<SEC-DOCUMENT>0001493152-24-004951.txt : 20240205
<SEC-HEADER>0001493152-24-004951.hdr.sgml : 20240205
<ACCEPTANCE-DATETIME>20240205170028
ACCESSION NUMBER:		0001493152-24-004951
CONFORMED SUBMISSION TYPE:	424B4
PUBLIC DOCUMENT COUNT:		18
FILED AS OF DATE:		20240205
DATE AS OF CHANGE:		20240205

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Cingulate Inc.
		CENTRAL INDEX KEY:			0001862150
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				863825535
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		424B4
		SEC ACT:		1933 Act
		SEC FILE NUMBER:	333-276502
		FILM NUMBER:		24596594

	BUSINESS ADDRESS:	
		STREET 1:		1901 W. 47TH PLACE
		CITY:			KANSAS CITY
		STATE:			KS
		ZIP:			66205
		BUSINESS PHONE:		(913) 942-2300

	MAIL ADDRESS:	
		STREET 1:		1901 W. 47TH PLACE
		CITY:			KANSAS CITY
		STATE:			KS
		ZIP:			66205
</SEC-HEADER>
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<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Filed
Pursuant to Rule 424(b)(4)</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Registration
No. 333-276502</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 34%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>PROSPECTUS</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 32%; text-align: center"></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 32%; text-align: right"></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>1,375,000</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B> Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>3,750,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Series
A Warrants to Purchase up to 3,750,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>1,875,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Series
B Warrants to Purchase up to 1,875,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>2,375,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Pre-Funded
Warrants to Purchase up to 2,375,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>8,000,000</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B> Shares of Common Stock Underlying
the Series A Warrants, Series B Warrants and Pre-Funded Warrants </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>150,000
</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Placement Agent Warrants to Purchase up to
150,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>150,000</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B> Shares of Common Stock Underlying
the Placement Agent Warrants</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_001.jpg" ALT="" STYLE="height: 59px; width: 173px"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cingulate
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are offering 1,375,000 shares of common stock, par value $0.0001 per share, together with Series A warrants to purchase up to
3,750,000 shares of common stock, which we refer to as the &#8220;Series A warrants,&#8221; and Series B warrants to purchase
up to 1,875,000 shares of common stock, which we refer to as the &#8220;Series B warrants,&#8221; at a combined public
offering price of $2.00 per share and accompanying warrants. The Series A warrants and the Series B warrants are hereinafter referred
to as the &#8220;warrants.&#8221; Each share of our common stock is being sold together with one Series A warrant to purchase one share
of common stock and one Series B warrant to purchase one-half of a share of common stock. The Series A warrants will have an exercise
price of $2.00 per share and will be exercisable immediately. The Series A warrants will expire on the five-year anniversary
of the date of issuance. The Series B warrants will have an exercise price of $2.00 per share and will be exercisable immediately.
The Series B warrants will expire on the two-year anniversary of the date of issuance. This prospectus also relates to
the offering of the shares of common stock issuable upon exercise of the Series A warrants and Series B warrants. </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are also offering to those investors, if any, whose purchase of shares of our common stock in this offering would result in such investor,
together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the investor, 9.99%)
of our outstanding common stock following the consummation of this offering, the opportunity to purchase, in lieu of the common stock
that would otherwise result in the investor&#8217;s beneficial ownership exceeding 4.99% (or, at the election of the investor, 9.99%),
pre-funded warrants each to purchase one share of our common stock at an exercise price of $0.0001, which we refer to as the &#8220;pre-funded
warrants.&#8221; Each pre-funded warrant will be exercisable upon issuance and will expire when exercised in full. Each pre-funded warrant
is being sold together with one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one-half
of a share of common stock. The public offering price for each pre-funded warrant and the accompanying warrants is equal to the price
per share of common stock and the accompanying warrants being sold to the public in this offering, minus $0.0001. This prospectus also
relates to the offering of the shares of common stock issuable upon exercise of the pre-funded warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
offering will terminate on February 14, 2024, unless we decide to terminate the offering (which we may do at any time in our discretion)
prior to that date. We will have one closing for all the securities purchased in this offering. The combined public offering price per
share (or pre-funded warrant) and accompanying warrants will be fixed for the duration of this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
shares of common stock and/or pre-funded warrants and the accompanying warrants can only be purchased together in this offering but will
be issued separately and will be immediately separable upon issuance.</FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have engaged H.C. Wainwright &amp; Co., LLC, or the placement agent, to act as our exclusive placement agent in connection with
this offering. The placement agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by
this prospectus. The placement agent is not purchasing or selling any of the securities we are offering and the placement agent is not
required to arrange the purchase or sale of any specific number or dollar amount of securities. We have agreed to pay to the placement
agent the placement agent fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus.
Since we will deliver the securities to be issued in this offering upon our receipt of investor funds, there is no arrangement for funds
to be received in escrow, trust or similar arrangement. There is no minimum offering requirement as a condition of closing of this offering.
Because there is no minimum offering amount required as a condition to closing this offering, we may sell fewer than all of the securities
offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive
a refund in the event that we do not sell an amount of securities sufficient to pursue our business goals described in this prospectus.
In addition, because there is no escrow account and no minimum offering amount, investors could be in a position where they have invested
in our company, but we are unable to fulfill all of our contemplated objectives due to a lack of interest in this offering. Further,
any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we
would be able to use such funds to effectively implement our business plan. See the section entitled &#8220;Risk Factors&#8221; for more
information. We will bear all costs associated with the offering. See &#8220;Plan of Distribution&#8221; on page 137 of this prospectus
for more information regarding these arrangements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>We
effected a 1-for-20 reverse stock split on November 30, 2023, pursuant to which every 20 shares of our issued and outstanding common
stock were reclassified as one share of common stock. The reverse stock split had no impact on the par value of our common stock or the
authorized number of shares of our common stock. Unless otherwise indicated, all share and per share information in this prospectus is
adjusted to reflect the reverse stock split. </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
common stock is listed on Nasdaq under the symbol &#8220;CING.&#8221; The closing price of our common stock on Nasdaq on February
2, 2024 was $1.33 per share. There is no established public trading market for the pre-funded warrants, Series A warrants
or Series B warrants, and we do not expect such a market to develop. We do not intend to apply to list the pre-funded warrants, Series
A warrants or Series B warrants on any securities exchange or other nationally recognized trading system. Without an active trading market,
the liquidity of the pre-funded warrants, Series A warrants and Series B Warrants will be limited.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are an &#8220;emerging growth company&#8221; under applicable Securities and Exchange Commission rules and will be subject to reduced
public company reporting requirements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Investing
in our securities is highly speculative and involves a high degree of risk. See &#8220;Risk Factors&#8221; beginning on page 7 of this
prospectus for a discussion of information that should be considered in connection with an investment in our securities.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="3" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Per Share and Accompanying Warrants</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="3" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Per Pre-Funded Warrant and Accompanying Warrants</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="3" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Total</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 46%">Public offering price</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right">2.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right">1.9999</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right">7,499,762.50</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Placement agent fees<SUP>(1)</SUP></FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">0.1560</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">0.1560</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">585,000.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Proceeds to us, before expenses <SUP>(2)</SUP></FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1.8440</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1.8439</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">6,914,762.50</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have agreed to pay the placement agent a cash fee equal to 7.8% of the gross proceeds raised in this offering. We have also
    agreed to reimburse the placement agent for certain of its offering related expenses, including reimbursement for non-accountable
    expenses in an amount up to $50,000, legal fees and expenses in the amount of up to $100,000, and for its clearing expenses in the
    amount of $15,950. In addition, we have agreed to issue the placement agent or its designees warrants to purchase a number of shares
    of common stock equal to 4.0% of the shares of common stock sold in this offering (including the shares of common stock issuable
    upon the exercise of the pre-funded warrants), at an exercise price of $2.50 per share, which represents 125% of the public
    offering price per share and accompanying warrant. For a description of compensation to be received by the placement agent, see &#8220;Plan
    of Distribution&#8221; for more information.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
    there is no minimum number of securities or amount of proceeds required as a condition to closing in this offering, the actual public
    offering amount, placement agent fees, and proceeds to us, if any, are not presently determinable and may be substantially less than
    the total maximum offering amounts set forth above. For more information, see &#8220;Plan of Distribution.&#8221;</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Delivery
of the securities offered hereby is expected to be made on or about February 6, 2024, subject to satisfaction of customary
closing conditions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 14pt"><B>H.C. Wainwright
&amp; Co.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
date of this prospectus is February 2, 2024.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>TABLE
OF CONTENTS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; width: 45px; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Page</B></FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#di_001">PROSPECTUS SUMMARY</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">1</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#di_002">THE OFFERING</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">5</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#di_003">RISK FACTORS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">7</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#TT_001">CAUTIONARY
    NOTE REGARDING FORWARD-LOOKING STATEMENTS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">58</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#TT_002">MARKET PRICE AND DIVIDEND INFORMATION</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">59</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#TT_003">BUSINESS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">60</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#di_004">MANAGEMENT&#8217;S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">100</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#s_001">SECURITY OWNERSHIP AND CERTAIN BENEFICIAL OWNERS AND MANAGEMENT</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">115</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_001">CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">117</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_002">MANAGEMENT</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">119<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_003">EXECUTIVE AND DIRECTOR COMPENSATION</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT>121</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_004">USE OF PROCEEDS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">128</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_005">DILUTION</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">129</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_006">DESCRIPTION OF CAPITAL STOCK</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">130<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_007">DESCRIPTION OF SECURITIES WE ARE OFFERING</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">133</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_008">PLAN OF DISTRIBUTION</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">137</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_009">LEGAL MATTERS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">140</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_010">EXPERTS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">140</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#p_011">WHERE YOU CAN FIND MORE INFORMATION</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">141</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#lpa_002">INDEX TO FINANCIAL STATEMENTS</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center">F-1<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>You
should rely only on the information contained in this prospectus. No one has been authorized to provide you with information that is
different from that contained in this prospectus. This prospectus is dated as of the date set forth on the cover hereof. You should not
assume that the information contained in this prospectus is accurate as of any date other than that date.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>For
investors outside the United States: </B>We have not done anything that would permit this offering or possession or distribution of this
prospectus in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform
yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="di_001"></FONT>PROSPECTUS
SUMMARY</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>This
summary highlights information contained elsewhere in this prospectus and does not contain all of the information that you should consider
before making your investment decision. Before investing in our securities, you should carefully read this entire prospectus, including
the &#8220;Risk Factors&#8221; section in this prospectus. If any of the risks materialize, our business, financial condition, operating
results, and prospects could be materially and adversely affected. In that event, the price of our securities could decline, and you
could lose part or all of your investment. Unless we state otherwise or the context otherwise requires, the terms &#8220;we,&#8221; &#8220;us,&#8221;
&#8220;our,&#8221; &#8220;our business,&#8221; &#8220;the Company&#8221; and &#8220;Cingulate&#8221; refer to and similar references
refer: (1) on or following the consummation of the Reorganization Merger (as defined below), including our initial public offering, to
Cingulate Inc. and its consolidated subsidiaries, including Cingulate Therapeutics LLC, or CTx; and (2) prior to the consummation of
the Reorganization Merger, including our initial public offering, to CTx and its consolidated subsidiaries.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Overview</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company using our proprietary Precision Timed Release<SUP>TM</SUP> (&#8220;PTR<SUP>TM</SUP>&#8221;) drug
delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives
of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment
outcomes. With an initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (&#8220;ADHD&#8221;), we are identifying
and evaluating additional therapeutic areas where our PTR technology may be employed to develop future product candidates, such as anxiety
disorders. Our PTR platform incorporates a proprietary Erosion Barrier Layer (&#8220;EBL&#8221;) designed to allow for the release
of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We are targeting the ADHD
treatment market, with an estimated US market size of over $23 billion as of November 2023, of which $18.6 billion is attributable
to stimulants. Stimulants are the most commonly prescribed class of medications for ADHD and account for approximately88% of all ADHD
medication prescriptions in the United States. By contrast, non-stimulant medications are typically employed only in the second-line
or adjunctive therapy setting and accounting for approximately 12% of all ADHD medication prescriptions. Extended-release, or long-acting,
dosage forms of stimulant medications are most frequently deployed as the first-line treatment for ADHD and constitute approximately
$16 billion of the overall ADHD market spend and accounting for 54% of all stimulant prescriptions. Most of these extended-release dosage
forms are approved for once-daily dosing in the morning and were designed to eliminate the need for re-dosing during the day. However,
with the current &#8216;once-daily&#8217; extended-release dosage forms, most patients still receive a second or &#8220;booster&#8221;
dose for administration later in the day (typically in the early afternoon) to achieve active-day coverage and suffer from a multitude
of unwanted side effects as a result. We believe there is a significant, unmet need within the current treatment paradigm for true once-daily
ADHD stimulant medications with a duration that provides entire active-day coverage combined with an improved side effect profile to
better serve the numerous unmet needs of patients.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
two proprietary, first-line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), are being developed
for the treatment of ADHD in the three main patient segments: children (ages 6 -12), adolescents (ages 13-17), and adults (ages18+).
Both CTx-1301 and CTx-1302 are designed to address the key shortcomings of currently approved stimulant therapies by: providing an immediate
onset of action (within 30 minutes); offering &#8216;entire active-day&#8217; duration; eliminating the need for a &#8216;booster/recovery&#8217;
dose of short-acting stimulant medications; minimizing or eliminating the rebound/crash symptoms associated with early medication &#8216;wear-off;&#8217;
and providing favorable tolerability with a controlled descent of drug blood levels. Furthermore, by eliminating the &#8216;booster&#8217;
dose used by up to 60% of ADHD patients in conjunction with their primary medication, we believe our product candidates will provide
important societal and economic benefits: reducing the abuse and diversion associated with short-acting stimulant medications; allowing
physicians to prescribe one medication versus two; allowing patients to pay for one medication versus two; and allowing payers to reimburse
one medication versus two.&#160;</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Recent
Developments</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>Debt Conversion </I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>&#160;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">In August 2022, we issued
a $5.0 million (the &#8220;Original Principal Amount&#8221;) promissory note (the &#8220;Original Note&#8221;) in favor of Werth Family
Investment Associates LLC (&#8220;WFIA&#8221;), and in May 2023, we issued an Amended and Restated Promissory Note (the &#8220;WFIA Note&#8221;)
increasing the principal amount under the Original Note by $3.0 million to $8.0 million. On September 8, 2023, Cingulate Inc. and CTx
entered into a note conversion agreement with WFIA, pursuant to which WFIA agreed to convert the Original Principal Amount under the
WFIA Note plus all accrued interest thereon, or $5,812,500, into pre-funded warrants (&#8220;September WFIA Pre-Funded Warrants&#8221;)
to purchase 341,912 shares of our common stock at a conversion price per pre-funded warrant of $17.00.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On January 25, 2024, we
entered into a note conversion agreement with WFIA (the &#8220;January 2024 Note Conversion Agreement&#8221;) and converted the remaining
$3.0 million of principal plus all accrued interest, or $3,287,500 into pre-funded warrants (the &#8220;January WFIA Pre-Funded Warrants&#8221;)
to purchase 687,043 shares of Common Stock at a conversion price per January WFIA Pre-Funded Warrant of $4.785 (the &#8220;January 2024
Debt Conversion&#8221;). The closing price of our common stock on January 24, 2024 was $4.35. The January WFIA Pre-Funded Warrants have
no expiration date and are exercisable immediately at an exercise price of $0.0001 per share, to the extent that after giving effect
to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section 13(d) of the Exchange Act, no more than 19.99%
of the outstanding shares of our common stock. After the conversion of the remaining principal amount plus all accrued interest thereon
and the issuance of the pre-funded warrants, the WFIA Note has been paid in full and the Company has no further obligations under the
WFIA Note.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>&#160;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>Chief Financial Officer Appointment </I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>&#160;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">On January 25, 2024, we
appointed Jennifer L. Callahan as our Senior Vice President and Chief Financial Officer. Ms. Callahan will serve as our Principal Financial
Officer and Principal Accounting Officer. In connection with Ms. Callahan&#8217;s appointment, CTx entered into an employment agreement
with Ms. Callahan on January 25, 2024. The employment agreement provides for a base salary of $350,000 annually. However, in connection
with the cost-containment measures disclosed on December 15, 2023, Ms. Callahan&#8217;s annual base salary is reduced by 40% to $210,000.
In connection with such reduction, we will pay Ms. Callahan, on the date that is three months after the filing date of the New Drug Application
for CTx-1301 with the Federal Drug Administration, an amount equal to the aggregate dollar amount of base salary through the payment
date that was not paid to her due to the salary reductions plus 20% of the reduction amount. In addition, Ms. Callahan is eligible to
receive an annual bonus, with a target amount equal to twenty-five percent (25%) of Ms. Callahan&#8217;s annual base salary. The actual
amount of each bonus will be determined by the sole discretion of our Compensation Committee and will be based upon both our performance
and Ms. Callahan&#8217;s individual performance, as recommended by our Chief Executive Officer.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Warrant
Exercises and ATM Sales</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>&#160;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the period beginning October 1, 2023 and ending on the date of this prospectus, investors have exercised certain of our outstanding pre-funded
warrants to purchase 260,261 of our common stock (such exercises, the &#8220;Warrant Exercises&#8221;). </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the period beginning October 1, 2023 and ending on the date of this prospectus, we sold 283,800 shares of common stock pursuant to an
At The Market Offering Agreement with H.C. Wainwright &amp; Co., LLC (the &#8220;ATM Agreement&#8221;), for net proceeds of $3,115,303
(the &#8220;ATM Sales&#8221;).</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><I>Reverse Stock Split</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B><I>&#160;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">We effected a 1-for-20
reverse stock split on November 30, 2023, pursuant to which every 20 shares of our issued and outstanding common stock were reclassified
as one share of common stock. The reverse stock split had no impact on the par value of our common stock or the authorized number of
shares of our common stock. Unless otherwise indicated, all share and per share information in this prospectus is adjusted to reflect
the reverse stock split<B>.</B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Going
Concern</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
offering is being made on a best efforts basis and we may sell fewer than all of the securities offered hereby and may receive significantly
less in net proceeds from this offering. We believe that the net proceeds from this offering, together with our cash on hand,
will satisfy our capital needs through late second quarter of 2024 under our current business plan. Following this offering,
we will need to raise additional capital to fund our operations and continue to support our planned development and commercialization
activities.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Nasdaq</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
common stock and warrants are currently listed for trading on Nasdaq. On May 16, 2023, we received a notice from the Listing Qualifications
Staff (the &#8220;Staff&#8221;) of The Nasdaq Stock Market LLC stating that we no longer comply with the minimum stockholders&#8217;
equity requirement of $2.5 million under the Nasdaq Stock Market Listing Rule 5550(b)(1) (the &#8220;Minimum Stockholders&#8217;
Equity Rule&#8221;) for continued listing. We submitted a plan of compliance to Nasdaq on June 30, 2023. On July 28, 2023, The Nasdaq
Stock Market notified us that that it granted an extension until November 13, 2023 to regain compliance with the Minimum Stockholders&#8217;
Equity Rule, conditioned upon achievement of certain milestones included in the plan of compliance previously submitted to The
Nasdaq Stock Market, including a plan to raise additional capital. On November 14, 2023, we received a letter from Nasdaq indicating
that, based upon our continued non-compliance with the Minimum Stockholders&#8217; Equity Rule, the Staff had determined to delist our securities from Nasdaq, subject to our request for a hearing before the Nasdaq Hearings Panel (the &#8220;Panel&#8221;).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
timely requested a hearing before Panel and Nasdaq granted our request. At the Panel hearing, which is expected to take place
in February 2024, we will submit our plan to regain compliance, as well as our ability to sustain long-term compliance, with all applicable
requirements for continued listing on Nasdaq, including compliance with the Minimum Stockholders&#8217; Equity Rule and the Independent
Director Rule (defined below). The delisting action by the Staff will be stayed pending the hearing and the expiration of any additional
extension period granted by the Panel following the Panel hearing. We intend to continue to take definitive steps in an effort to evidence
compliance with the Minimum Stockholders&#8217; Equity Rule, the Independent Director Rule and other Nasdaq listing requirements; however,
there can be no assurance that the Panel will grant our request for continued listing or that we will be able to evidence compliance
with the Minimum Stockholders&#8217; Equity Rule, the Independent Director Rule and other Nasdaq listing requirements within any extension
period that may be granted by the Panel. Even if we regain compliance with the Minimum
Stockholders&#8217; Equity Rule, to remain listed we will need to evidence the ability to maintain long term compliance with the Minimum
Stockholders&#8217; Equity Rule.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
July 28, 2023, we received notice from The Nasdaq Stock Market indicating that we were not in compliance with the requirement
to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq. We were provided a compliance period of 180 calendar
days from the date of the notice, or until January 24, 2024, to regain compliance with the minimum closing bid requirement, pursuant
to the Nasdaq Stock Market Listing Rule 5810(c)(3)(A). On November 30, 2023, we effected a reverse stock split of our common stock,
and on December 15, 2023, we received notice from The Nasdaq Stock Market that we have regained compliance with minimum closing
bid price requirement. There can be no assurance that we will continue to maintain compliance with the minimum closing bid price requirement
or the other Nasdaq listing requirements.</FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
December 26, 2023, we received a letter from the Staff indicating that, based upon the resignation of three members of our Board of Directors
(&#8220;Board&#8221;) on December 12, 2023 and December 13, 2023, we no longer comply with the independent director, audit committee,
compensation committee and independent director oversight of director nominations requirements as set forth in Nasdaq Listing Rule 5605
(the &#8220;Independent Director Rule&#8221;). Our Board currently consists of two directors, neither of whom are independent.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are in the process of identifying potential new directors and intend to show progress in complying with the Independent Director Rule
prior to the Panel hearing. There can be no assurance that we will regain compliance with the Independent Director Rule.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
must satisfy Nasdaq&#8217;s continued listing requirements, including, among other things, the Minimum Stockholders&#8217; Equity Rule
and the Independent Director Rule or risk delisting, which could have a material adverse effect on our business. If our common stock
and warrants are delisted from Nasdaq, it could materially reduce the liquidity of our common stock and warrants and result in a corresponding
material reduction in the price of our common stock and warrants as a result of the loss of market efficiencies associated with Nasdaq
and the loss of federal preemption of state securities laws. In addition, delisting could harm our ability to raise capital through alternative
financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers
and employees and fewer business development opportunities. If our common stock and warrants are delisted, it could be more difficult
to buy or sell our common stock and warrants or to obtain accurate quotations, and the price of our common stock and warrants could suffer
a material decline. Delisting could also impair our ability to raise capital on acceptable terms, if at all.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Organizational Structure</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is a Delaware corporation that was formed to serve as a holding company. In connection with our initial public offering, we effected
certain organizational transactions. On September 29, 2021, Cingulate acquired Cingulate Therapeutics LLC, or CTx, through the merger
of a wholly-owned acquisition subsidiary of Cingulate with and into CTx (the &#8220;Reorganization Merger&#8221;). As a result of the
Reorganization Merger, CTx became a wholly-owned subsidiary of Cingulate. Unless otherwise stated or the context otherwise requires,
all information in this prospectus reflects the consummation of the Reorganization Merger.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Corporate
Information</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
primary executive offices are located at 1901 West 47<SUP>th</SUP> Place, Kansas City, Kansas 66205 and our telephone number is (913)
942-2300. Our website address is <I>www.cingulate.com</I>. The information contained on, or that can be accessed through, our website
is not part of this prospectus and should not be considered as part of this prospectus or in deciding whether to purchase our securities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate,
PTR, Cingulate Therapeutics, Enfoqis, Enfoqus, Trodesca, Ivoqus, Taylerza, Tymprezi, Accomplish, Mastery and our logo are some of our
trademarks used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of other
organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus may appear without the &#174; and
&#8482; symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under
applicable law, our rights or the right of the applicable licensor to these trademarks and tradenames.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Implications
of Being an Emerging Growth Company</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a company with less than $1.235 billion in revenue during our most recently completed fiscal year, we qualify as an &#8220;emerging growth
company&#8221; as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage
of relief from certain reporting requirements and other burdens that are otherwise applicable generally to public companies. These provisions
include:</FONT></P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced
    obligations with respect to financial data, including presenting only two years of audited financial statements and only two years
    of selected financial data in this prospectus;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    exception from compliance with the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act of 2002, as amended,
    or the Sarbanes-Oxley Act;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may take advantage of exemptions for up to five years or such earlier time that we are no longer an emerging growth company. Accordingly,
the information contained herein may be different than the information you receive from other public companies in which you hold stock.
We would cease to be an emerging growth company upon the earliest to occur of: (1) the last day of the fiscal year in which we have more
than $1.235 billion in annual gross revenue; (2) December 31, 2026; (3) the date we are deemed to be a &#8220;large accelerated filer&#8221;
as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act; and (4) the date on which we have during the previous
three-year period issued more than $1.0 billion in non-convertible debt securities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
JOBS Act also permits us, as an emerging growth company, to take advantage of an extended transition period to comply with the new or
revised accounting standards applicable to public companies and thereby allow us to delay the adoption of those standards until those
standards would apply to private companies. We have irrevocably elected to avail ourselves of this exemption and therefore, we will not
be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="di_002"></FONT>THE
OFFERING</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>The
following summary contains basic information about this offering. This summary is qualified in its entirety by the more detailed information
included in this prospectus. Before making your investment decision with respect to our securities, you should carefully read this entire
prospectus, including the information under &#8220;Risk Factors,&#8221; &#8220;Management&#8217;s Discussion and Analysis of Financial
Condition and Results of Operations,&#8221; and the financial statements included elsewhere in this prospectus.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 30%; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Common
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,375,000</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">
    shares.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Pre-Funded
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are also offering pre-funded warrants to purchase up to 2,375,000 shares of common stock  to those investors whose purchase
    of shares of our common stock in this offering would result in such investor, together with its affiliates and certain related parties,
    beneficially owning more than 4.99% (or, at the election of the investor, 9.99%) of our outstanding common stock following the consummation
    of this offering, in lieu of the common stock that would otherwise result in such excess. Each pre-funded warrant is being
    sold together with one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one-half of a
    share of common stock. The combined public offering price for each pre-funded warrant and accompanying warrants is equal to the combined
    public offering price per share of common stock and accompanying warrants being sold in this offering, minus $0.0001, and the exercise price of each pre-funded warrant will be $0.0001 per share. This prospectus
    also relates to the offering of the shares of common stock issuable upon exercise of the pre-funded warrants. See &#8220;Description
    of Securities We Are Offering&#8221; for additional information.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Warrants
    Offered</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Each
    share of common stock or pre-funded warrant is being offered together with one Series A warrant to purchase one share of common stock
    and one Series B warrant to purchase one-half of a share of common stock. The Series A warrants will have an exercise price of $2.00
    per share and will be exercisable immediately. The Series A warrants will expire on the five-year anniversary of the date
    of issuance. The Series B warrants will have an exercise price of $2.00 per share and will be exercisable immediately.
    The Series B warrants will expire on the two-year anniversary of the date of issuance. See &#8220;Description of
    Securities We Are Offering&#8221; for additional information.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Common
    Stock Outstanding prior to this Offering (1)</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,450,171
    shares.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Common
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">5,200,171 shares, assuming all of the pre-funded
    warrants offered hereby are exercised and no exercise of the warrants offered hereby.</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Use
    of Proceeds</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">We estimate that the net proceeds of this offering assuming
    no exercise of the warrants, after deducting placement agent fees and estimated offering expenses, will be approximately $6.5
    million. We intend to use all of the net proceeds we receive from this offering for continued research and development and commercialization
    activities of CTx-1301, and for working capital, capital expenditures and general corporate purposes, including investing further
    in research and development efforts. We believe that the net proceeds from this offering, together with our cash on hand,
    will satisfy our capital needs through late second quarter of 2024 <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">under
    our current business plan. Following this offering, we will need to raise additional capital to fund our operations and continue
    to support our planned development and commercialization activities. See &#8220;Use of Proceeds.&#8221;</FONT></TD></TR>
</TABLE>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 30%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Nasdaq
    Capital Market Symbol</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
    common stock is listed on Nasdaq under the symbol &#8220;CING.&#8221; We do not intend to apply to list the pre-funded
    warrants, Series A warrants or Series B warrants on any securities exchange or other nationally recognized trading system. Without
    an active trading market, the liquidity of the pre-funded warrants, Series A warrants and Series B warrants will be limited.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Lock-up</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
    of our directors and executive officers have agreed, subject to certain exceptions, not to sell, transfer or dispose of, directly
    or indirectly, any of our common stock or securities convertible into or exercisable or exchangeable for our common stock for a period
    of 90 days after the closing of this offering. See &#8220;Plan of Distribution&#8221; for more information.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Placement
    Agent Warrants</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;We
    have agreed to issue to the placement agent or its designees, warrants, or the placement agent warrants, to purchase up to 4.0%
    of the aggregate number of shares of common stock sold in this offering (including the shares of common stock issuable upon the
    exercise of the pre-funded Warrants) at an exercise price equal to 125% of the public offering price per share and accompanying warrants
    to be sold in this offering. The placement agent warrants will be exercisable upon issuance and will expire five years from the commencement
    of sales under this offering. See &#8220;Plan of Distribution&#8221; for additional information.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risk
    Factors</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Investment
    in our securities involves a high degree of risk and could result in a loss of your entire investment. See &#8220;Risk Factors&#8221;
    beginning on page 7 of this prospectus for a discussion of the factors you should consider carefully before deciding to invest
    in our securities.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)
The number of shares of our common stock to be outstanding immediately after this offering is based on 1,450,171 shares of our common
stock outstanding as of January 25, 2024 and excludes, as of such date, the following:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">73,647
    </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of our common stock issuable upon exercise
    of outstanding stock options issued under our 2021 Equity Incentive Plan (the &#8220;2021 Plan&#8221;), with a weighted average exercise
    price of $59.72 per share;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock issuable upon the exercise
    of pre-funded warrants with a weighted average exercise price of $0.0007314 per share.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 20pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unless
expressly indicated or the context requires otherwise, all information in this prospectus assumes (i) we issue no pre-funded warrants
and (ii) no exercise of the warrants offered hereby.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="di_003"></FONT>RISK
FACTORS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Investment
in our securities involves risk. You should carefully consider the following risk factors in addition to the other information included
in this prospectus, including matters addressed in the section entitled &#8220;Cautionary Note Regarding Forward-Looking Statement.&#8221;
These risk factors are not exhaustive, and investors are encouraged to perform their own investigation with respect to our business,
financial condition and prospects. We may face additional risks and uncertainties that are not presently known to us, or that we currently
deem immaterial, which may also impair our business or financial condition. If any of these risks actually occur, our business, financial
condition and results of operations could be materially and adversely affected and we may not be able to achieve our goals, the value
of our securities could decline and you could lose some or all of your investment. Additional risks not presently known to us or that
we currently believe are immaterial may also significantly impair our business operations. If any of these risks occur, our business,
results of operations or financial condition and prospects could be harmed. In that event, the market price of our common stock and the
value of the warrants could decline, and you could lose all or part of your investment. The following discussion should be read in conjunction
with the financial statements and notes to the financial statements included herein.</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Summary
of Risks</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following summarizes key risks and uncertainties that could materially adversely affect us. You should read this summary together with
the more detailed description of each risk factor contained below.</FONT></P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are a biopharmaceutical company with a limited operating history and need additional capital to continue operations, including to
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have incurred a history of operating losses and expect to continue to incur substantial costs for the foreseeable future. We are
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Following
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    required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for
    the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are in either in product/early clinical development
    (CTx-2103), clinical development (CTx-1301) or planned for future product development (CTx-1302) and are not yet
    approved. We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product
    candidates, which is necessary before they can be commercialized.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
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    ongoing government regulation. The commercial success of our product candidates, if approved, depends partially upon attaining market
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Social
    issues around the abuse of opioids and stimulants, including law enforcement concerns over diversion and regulatory efforts to combat
    abuse, could decrease the potential market for our product candidates.</FONT></TD></TR>
  </TABLE>
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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Our Financial Position and Need for Capital</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
are a biopharmaceutical company with a limited operating history.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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are a biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We must complete
clinical studies and receive regulatory approval before commercial sales of a product can commence. The likelihood of success of our
business plan must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered
in connection with developing and expanding early-stage businesses and the regulatory and competitive environment in which we operate.
Pharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive
business.</FONT></P>

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you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in
the early stages of development, especially early-stage pharmaceutical companies such as ours. Potential investors should carefully consider
the risks and uncertainties that a company with a limited operating history will face. In particular, potential investors should consider
that we cannot assure you that we will be able to, among other things:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">raise
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">attract
    and retain an experienced management and advisory team in light of the departure of executive officers and other employees in December
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">secure
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">utilize
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we cannot successfully execute any one of the foregoing, our business, financial condition, results of operations and future growth prospects
would be materially and adversely affected.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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have incurred a history of operating losses and expect to continue to incur substantial costs for the foreseeable future. We are not
currently profitable, and we may never achieve or sustain profitability.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have never generated revenue from operations, are unlikely to generate revenues for several years, and are currently operating at a loss
and expect our operating costs will increase significantly as we incur costs related to formulation/manufacturing development, the clinical
trials for our drug candidates and operating as a public company. We expect to incur expenses without corresponding revenues unless and
until we are able to obtain regulatory approval and successfully commercialize our product candidates, CTx-1301, CTx-1302 and CTx-2103.
We may never be able to obtain regulatory approval for the marketing of our drug candidates in any indication in the United States or
internationally. Even if we obtain regulatory approval for CTx-1301, CTx-1302 and/or CTx-2103, development expenses will continue to
increase for any future assets. As we conduct CTx-1301 Phase 3 clinical trials in pursuit of Federal Drug Administration (&#8220;FDA&#8221;)
approval, we will incur additional clinical development expenses.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have incurred recurring losses since inception and had an accumulated deficit of approximately $86.0 million as of September 30, 2023.
These conditions raise substantial doubt about our ability to continue as a going concern, meaning that we may be unable to continue
operations for the foreseeable future or realize assets and discharge liabilities in the ordinary course of operations. If we are unable
to obtain further funding, we  may be unable to continue operations. Although we continue to pursue
these plans, there can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing
operations, if at all.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
will continue to expend substantial cash resources for the foreseeable future for the clinical development of our product candidates
and development of any other indications and product candidates we may choose to pursue. These expenditures will include costs associated
with manufacturing and clinical development, such as conducting clinical trials, manufacturing operations and product candidate supply,
as well as marketing and selling any products approved for sale. In particular, our Phase 3 trials in the United States require substantial
funds to complete. Because the conduct and results of any clinical trial are highly uncertain, we cannot reasonably estimate the actual
amounts necessary to successfully complete the development and commercialization of our current and any future product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are uncertain when or if we will be able to achieve or sustain profitability. If we achieve profitability in the future, we may not be
able to sustain profitability in subsequent periods. Failure to become and remain profitable would impair our ability to sustain operations
and adversely affect the price of our securities and our ability to raise capital.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B><I>Following this offering, we will need to raise
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or other alternatives that would likely result in our securityholders losing some or all of their investment in us.</I></B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I></I></B></FONT></P>

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this offering, we will need to raise significant additional capital to continue operations and continue to support our planned development
and commercialization activities We believe that the net proceeds from this offering, together with our cash on hand, will satisfy
our capital needs through late second quarter of 2024 under our current business plan. The amount and timing of our future
funding requirements will depend on many factors, including:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot be certain that additional funding will be available on acceptable terms, or at all. In addition, future debt financing into which
we may enter may impose upon us covenants that restrict our operations, including limitations on our ability to incur liens or additional
debt, pay dividends, redeem our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
late 2023, we initiated several cost cutting measures. These measures include reductions in employee base salaries and a review of essential
vendors. In addition, non-management members of the Board had agreed to defer their cash Board fees until a future date. If we are unable
to raise additional capital when required or on acceptable terms or if we are unable to enter into strategic collaborations for CTx-1301,
CTx-1302, and/or CTx-2103, we may be required to further restrict our operations or obtain funds by entering into agreements on unattractive
terms, which would likely have a material adverse effect on our business, stock price and our relationships with third parties with whom
we have business relationships, at least until additional funding is obtained.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Raising
additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product
candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through public or private equity
or debt financings, third-party funding, marketing and distribution arrangements, as well as other collaborations, strategic alliances
and licensing arrangements, or any combination of these approaches. We do not have any committed external source of funds. To the extent
that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest in our company may
be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder.
Debt and equity financings, if available, may involve agreements that include covenants limiting or restricting our ability to take specific
actions, such as redeeming our shares, making investments, incurring additional debt, making capital expenditures, declaring dividends
or placing limitations on our ability to acquire, sell or license intellectual property rights. In addition, WFIA holds pre-funded
warrants to purchase 1,028,955 shares of our common stock. Upon any exercise of such pre-funded warrants, your ownership interest in
our company will be diluted. </FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we raise additional capital through future collaborations, strategic alliances or third-party licensing arrangements, we may have to
relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, or grant licenses
on terms that may not be favorable to us. If we are unable to raise additional capital when needed, we may be required to delay, limit,
reduce or terminate our product candidates&#8217; development or future commercialization efforts, or grant rights to develop and market
product candidates that we would otherwise develop and market ourselves.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Changes
in tax laws may materially adversely affect our business, financial condition, results of operations and cash flows.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are subject to tax laws, regulations and policies of the jurisdictions in which we do business, which may include United States
federal, state, and local governments and taxing authorities in foreign jurisdictions. Changes in tax laws, as well as other factors,
could cause us to experience fluctuations in our tax obligations and otherwise adversely affect our tax positions and/or our tax liabilities.
The income tax rules in the jurisdictions in which we operate are constantly under review by taxing authorities and other governmental
bodies. Changes to tax laws (which changes may have retroactive application) could adversely affect us or our stockholders. We are unable
to predict what tax proposals may be proposed or enacted in the future or what effect such changes would have on our business, but such
changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our financial position
and overall effective tax rates in the future in jurisdictions where we have operations, and increase the complexity, burden, and cost
of tax compliance.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
ability to use our net operating losses to offset future taxable income may be subject to certain limitations.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
net operating loss carryforwards (&#8220;NOLs&#8221;), and certain other tax attributes could be unavailable to offset future
income tax liabilities because of restrictions under U.S. tax law. Under the Tax Cuts and Jobs Act, or the TCJA, federal NOLs generated
in tax years ending after December 31, 2017 may be carried forward indefinitely. The carryforwards are limited to 80% of each subsequent
year&#8217;s net income.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, Sections 382 and 383 of the Code, contain rules that limit the ability of a corporation that undergoes an &#8220;ownership
change&#8221; (generally, any change in ownership of more than 50% of the corporation&#8217;s stock over a three-year period) to utilize
its pre-change NOLs and tax credit carryforwards to offset future taxable income. These rules generally operate by focusing on ownership
changes involving stockholders owning directly or indirectly 5% or more of the stock of a corporation and any change in ownership arising
from a new issuance of stock by the company. Generally, if an ownership change occurs, the yearly taxable income limitation on the use
of NOLs and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate
and the value of the corporation&#8217;s stock immediately before the ownership change. As a result, following any such ownership change,
we might be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire,
in which event we could incur larger federal and state income tax liabilities than we would have had we not experienced an ownership
change.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>The
report of our independent registered public accounting firm for the fiscal years ended December 31, 2022 and 2021 contains an explanatory
paragraph regarding substantial doubt about our ability to continue as a going concern.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
report of our independent registered public accounting firm on our financial statements as of and for the years ended December 31, 2022
and December 31, 2021 includes an explanatory paragraph indicating that there is substantial doubt about our ability to continue as a
going concern. Since inception, we have experienced recurring operating losses and negative cash flows, and we expect to continue to
generate operating losses and consume significant cash resources for the foreseeable future. Without additional financing, these conditions
raise substantial doubt about our ability to continue as a going concern, meaning that we may be unable to continue operations for the
foreseeable future or realize assets and discharge liabilities in the ordinary course of operations. If we are unable to obtain funding,
we may be unable to continue operations. Although we continue to pursue
these plans, there can be no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing
operations, if at all.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Development, Clinical Testing, Manufacturing and Regulatory Approval</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I></I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B><I>We are dependent primarily on the successful
development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for
the treatment of anxiety, which are either in product/early clinical development (CTx-2103), clinical development
(CTx-1301) or planned for future product development (CTx-1302) and are not yet approved. We cannot give any assurance that we
will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized.</I></B></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I></I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have not completed development of and/or obtained regulatory approval for any of our product candidates. Development will require the
commitment of substantial financial resources, extensive product candidate development, and clinical trials. This process takes years
of effort without any assurance of ultimate success.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to generate revenue from our product candidates, which we do not expect will occur for several years, if ever, will depend heavily
on their successful development, regulatory approval, and eventual commercialization. The success of our product candidates will depend
on many factors, including, but not limited to:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">successful
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">successful
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">competing
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtaining
    and maintaining healthcare coverage and adequate reimbursement; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">maintaining
    a continued acceptable safety and efficacy profile of the drug products following approval.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are unable to achieve one or more of the above factors, many of which are beyond our control, in a timely manner or at all, we could
experience significant delays and increased costs or an inability to obtain regulatory approvals or commercialize our product candidates.
Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly,
we cannot assure you that we will be able to generate sufficient revenue through the sale of our product candidates or any future product
candidates to continue operations.</FONT></P>

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product development efforts with respect to CTx-1301, CTx-1302 and/or CTx-2103 may fail for many reasons, including but not limited to:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in">&#160;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Premarket
review of our product candidates by the FDA or other regulatory authorities is a lengthy and uncertain process and approval may be delayed,
limited or denied, any of which would adversely affect our ability to generate operating revenues.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are not permitted to market our drug product candidates in the United States until we receive the respective approval of a New Drug
Application (&#8220;NDA&#8221;) from the FDA. The time required to obtain approval, if any, by the FDA is unpredictable, but
typically takes multiple years following the commencement of clinical trials, and depends upon numerous factors, including the substantial
discretion of the regulatory authorities and the type, complexity and novelty of the product candidates involved. We have not submitted
a marketing application such as an NDA to the FDA or any similar application to any other regulatory authority in any jurisdiction.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of a product candidate
for many reasons. For example, the FDA:</FONT></P>

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    marketing approval in the United States, including any findings that the safety risks outweigh clinical and other benefits of our
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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time and expense of the approval process, as well as the unpredictability of future clinical trial results and other contributing factors,
may result in our failure to obtain regulatory approval to market, in the United States or other jurisdictions, CTx-1301, CTx-1302, CTx-2103,
or any other drug candidates we are developing or may seek to develop in the future, which would significantly harm our business, results
of operations and prospects. In such case, we may also not have the resources to conduct new clinical trials and/or we may determine
that further clinical development of any such drug candidate is not justified and may discontinue any such programs.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Clinical
testing is expensive, difficult to design and implement, can take many years to complete and is outcome uncertain. We may incur additional
costs or experience delays in completing, or ultimately be unable to complete, the commercialization of our product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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is impossible to predict when or if any of our product candidates will prove effective or safe in humans and will receive regulatory
approval. Before obtaining marketing approval from regulatory authorities for the sale of any product candidate, we must complete product/manufacturing
development and then conduct clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical trials
are expensive, difficult to design and implement, can take many years to complete and are uncertain as to outcome. A failure of
one or more clinical trials can occur at any stage of development. The outcome of early clinical trials may not be predictive of the
success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Interpretation of
results from early, usually smaller, studies that suggest positive trends in some subjects, requires caution. Results from later stages
of clinical trials enrolling more subjects may fail to show the desired safety and efficacy results or otherwise fail to be consistent
with the results of earlier trials of the same product candidates. Later clinical trial results may not replicate earlier clinical trials
for a variety of reasons, including differences in trial design, different trial endpoints, or lack of trial endpoints in studies, subject
population, number of subjects, subject selection criteria, trial duration, drug dosage and formulation and lack of statistical power
in the earlier studies. Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies that
have believed their product candidates performed satisfactorily in early and later stage clinical trials have nonetheless failed to obtain
marketing approval of their products.</FONT></P>

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may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive
marketing approval or commercialize our product candidates, including but not limited to:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    delay or failure in identifying and maintaining a sufficient number of trial sites, many of which may already be engaged in other
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    in cases where that is required, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">failure
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</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    to initiate or delay of or inability to complete a clinical trial as a result of a clinical hold imposed by the FDA or comparable
    regulatory authority due to observed safety findings or other reasons;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    authorities may not agree with our trial design or implementation;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">inability
    to manufacture sufficient quantities of a drug candidate of acceptable quality for use in clinical trials; and</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators
    or institutional review boards to suspend or terminate the trials.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate,
if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials
or tests are not positive or are only modestly positive or if there are safety concerns, we may:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">be
    delayed in obtaining marketing approval for our product candidates;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain
    approval for indications or patient populations that are not as broad as intended or desired;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">be
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">have
    the product removed from the market after obtaining marketing approval.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
development costs may also increase if we experience delays in testing, clinical trials, manufacturing or obtaining marketing approvals.
For example, our development costs increased for CTx-1301 due to rescheduling of the Phase 3 fixed-dose study as a result of manufacturing
delays for the final dosage strengths needed for that study. We do not know whether any of our clinical trials will begin as planned,
will need to be restructured or will be completed on schedule, or at all. In late 2023, we announced a change in the clinical development
plan for CTx-1301 based on feedback from FDA, and accordingly stopped enrollment in two Phase 3 trials of CTx-1301. We may need
to restart these trials and/or start new trials in order to win regulatory approval of CTx-1301. We may find it difficult or impossible
to restart or start such clinical trials.. Significant product manufacturing or clinical trial delays also could shorten any periods
during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market
before we do and impair our ability to successfully commercialize our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Obtaining
regulatory approval for clinical trials of CTx-1301 and CTx-1302 in children and adolescents may require additional studies and/or longer
duration of studies since the requirements for regulatory approval for the pediatric populations are more stringent.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pediatric
drug development may require additional studies to determine safe dosing and long-term safety. These additional studies may require investment
of significant additional resources beyond those required for regulatory approval of the drugs in adults. Although, we have stopped enrollment
in the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study of CTx-1301 and the Phase 3 pediatric dose-optimization
onset and duration study of CTx-1301, we may have to restart and complete these and other trials in order to obtain approval. Approval
of CTx-1301 and CTx-1302 may be delayed due to these additional requirements and this may have an adverse effect on the commercial prospects
of CTx-1301 and CTx-1302, as well as delay our ability to generate product revenue, possibly materially. In addition, as a result of
COVID-19 (or other potential pandemics), there may be a smaller pool of children from which we can enroll for our clinical trials. We
cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric populations or the
adult population.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Changes
in methods of product candidate manufacturing or formulation may result in additional costs or delay.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
product candidates are developed through nonclinical testing and early to late-stage clinical trials towards potential approval and commercialization,
various aspects of the development program, such as manufacturing methods and formulation, may be altered along the way in an effort
to optimize processes and results. Such changes may not achieve these intended objectives. Any of these changes could cause our product
candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the
altered materials, or they may alter the safety or risk profile of the product candidate that could involve further FDA or other regulatory
agency inquiries. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of
clinical trials, require the performance of bridging clinical trials or the repetition of one or more clinical trials, increase clinical
trial costs, delay approval of our product candidates and jeopardize our ability to commence product sales and generate revenue.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
product candidates CTx-1301 and CTx-1302 contain controlled substances, the manufacture, use, sale, importation, exportation, prescribing
and distribution of which are subject to regulation by the DEA.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Before
we can commercialize our product candidates, the DEA will need to determine the controlled substance schedule, taking into account
the recommendation of the FDA. This may be a lengthy process that could delay our marketing of a product candidate and could potentially
diminish any regulatory exclusivity periods for which we may be eligible. Our CTx-1301 and CTx-1302 product candidates, if approved,
will be regulated as &#8220;controlled substances&#8221; as defined in the Controlled Substances Act of 1970 (the &#8220;CSA&#8221;)
and the implementing regulations of the DEA, which establish registration, security, recordkeeping, reporting, storage, distribution,
importation, exportation, inventory, quota and other requirements administered by the DEA. These requirements are applicable to us, our
contract manufacturers and distributors, as well as prescribers and dispensers of our product candidates. The DEA regulates the handling
of controlled substances through a closed chain of distribution. This control extends to the equipment and raw materials used in the
manufacturing and packaging, in order to prevent loss and diversion into illicit channels of commerce. A number of states and foreign
countries also independently regulate these drugs as controlled substances.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
DEA regulates controlled substances as Schedule I, II, III, IV or V substances. An approved pharmaceutical product may be listed as Schedule
II, III, IV or V, depending on the potential for abuse and physical or psychological dependence, with Schedule II substances considered
to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances. Schedule II drugs
are those that meet the following characteristics:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">abuse
    of the drug may lead to severe psychological or physical dependence.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
active pharmaceutical ingredients in CTx-1301 and CTx-1302 (dexmethylphenidate and dextroamphetamine) are currently listed as Schedule
II products. We expect that some of our future product candidates may also be listed by the DEA as Schedule II controlled substances
under the CSA. Consequently, the manufacturing, shipping, storing, selling and using of the products, if approved, will be subject to
a high degree of regulation. Schedule II drugs are subject to the strictest requirements for registration, security, recordkeeping and
reporting, and the distribution, prescribing and dispensing of these drugs are highly regulated.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Annual
registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance. The
registration is specific to the particular location, activity and controlled substance schedule.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, a DEA quota system controls and limits the availability and production of controlled substances, and our products may be subject
to the DEA&#8217;s production and procurement quota scheme. The DEA establishes an aggregate quota for how much of a controlled substance
may be produced in total in the United States based on the DEA&#8217;s estimate of the quantity needed to meet legitimate scientific
and medicinal needs. Manufacturers of controlled substances are required to apply for quotas on an annual basis. If we or our contract
manufacturers or suppliers do not obtain a sufficient quota from DEA, we may not be able to obtain sufficient quantities of these controlled
substances in order to complete our clinical trials or meet commercial demand, if our product candidates are approved for marketing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
of their restrictive nature, these laws and regulations could limit commercialization of our product candidates containing controlled
substances. Failure to comply with these laws and regulations could also result in withdrawal of our DEA registrations, disruption in
manufacturing and distribution activities, consent decrees, criminal and civil penalties and state actions, among other consequences.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we experience delays or difficulties in the enrollment of subjects in clinical trials, our receipt of necessary regulatory approvals
could be delayed or prevented.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient
number of eligible subjects to participate in these trials as required by the FDA or similar regulatory authorities outside the United
States. We cannot predict how successful we will be at enrolling subjects in future clinical trials. If we are not successful at enrolling
subjects in one clinical trial, it may affect when we are able to initiate our next clinical trial, which could result in significant
delays in our efforts to pursue regulatory approval of and commercialize our product candidates. In addition, some of our competitors
have ongoing clinical trials to treat the same indications as our product candidates, and subjects who would otherwise be eligible for
our clinical trials may instead enroll in clinical trials of our competitors. Subject enrollment is affected by other factors including,
but not limited to:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    presence of other drug candidates in clinical development for the same indication; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    proximity and availability of clinical trial sites for prospective subjects.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
inability to enroll a sufficient number of subjects for clinical trials would result in significant delays and could require us to abandon
one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs for our
product candidates, which could cause our value to decline and limit our ability to obtain additional financing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects
may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization,
increase our costs or necessitate the abandonment or limitation of the development of some or all of our product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate thorough, lengthy, complex and
expensive product development and clinical trials that our product candidates are both safe and effective for use in each target indication,
and failures can occur at any stage of development. Clinical trials often fail to demonstrate safety and efficacy of the product candidate
studied for the target indication.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
with many pharmaceutical products, treatment with our product candidates may produce undesirable side effects or adverse reactions or
events. Although our product candidates contain active pharmaceutical ingredients that have already been approved, meaning that the side
effects arising from the use of the active pharmaceutical ingredient or class of drug in our product candidates are generally known,
our product candidates still may cause undesirable side effects.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
our product candidates are associated with serious side effects in clinical trials or have characteristics that are unexpected, we may
need to limit development to more narrow uses or subpopulations in which the side effects or other characteristics are less prevalent,
less severe or more acceptable from a risk-benefit perspective. The FDA or an institutional review board may also require that we suspend,
discontinue, or limit our clinical trials based on safety information to limit potential serious harm to enrolled subjects. Such findings
could further result in regulatory authorities failing to provide marketing authorization for our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit
the scope of any approved label or market acceptance, or result in significant negative consequences following marketing approval, if
any.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
any of our products cause serious or unexpected side effects after receiving market approval, a number of potentially significant negative
consequences could result, including, but not limited to:</FONT></P>

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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    required to implement a Risk Evaluation and Mitigation Strategy (&#8220;REMS&#8221;) to ensure that the benefits of the product
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    may be required to change the way the product is distributed or administered;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    may need to voluntarily recall our products;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we
    could be sued and held liable for harm caused to individuals exposed to or taking our product candidates; or</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    reputation may suffer.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
of these events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate and could
substantially increase the costs of commercializing our products and product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
the FDA does not conclude that our product candidates are sufficiently bioequivalent, or have comparable bioavailability, to approved
reference drugs, or if the FDA does not allow us to pursue the 505(b)(2) NDA pathway as anticipated, the approval pathway for our product
candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than
anticipated, and the FDA may not ultimately approve our product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section
505(b)(2) of the Federal Food, Drug and Cosmetic Act (the &#8220;FDCA&#8221;) permits the filing of an NDA where at least some
of the information required for approval comes from investigations that were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. The FDA interprets
Section 505(b)(2) of the FDCA, for the purposes of approving an NDA, to permit the applicant to rely, in part, upon published literature
or the FDA&#8217;s previous findings of safety and efficacy for an approved product. The FDA may also require the applicant to perform
additional clinical trials or measurements to support any deviation from the previously approved product. The FDA may then approve the
new product candidate for all or some of the label indications for which the referenced product has been approved, as well as for any
new indication sought by the Section 505(b)(2) applicant. The FDA may require an applicant&#8217;s product label to have all or some
of the limitations, contraindications, warnings or precautions included in the reference product&#8217;s label, including a black box
warning, or may require the label to have additional limitations, contraindications, warnings or precautions. A key element of our strategy
is to seek FDA approval for our current product candidates, CTx-1301, CTx-1302, and CTx-2103, through the 505(b)(2) NDA pathway. If the
FDA determines that our product candidates do not meet the requirements of Section 505(b)(2), or if we cannot demonstrate bioequivalence
or comparable bioavailability of our product candidates to approved products, we may need to conduct additional clinical trials, provide
additional data and information, and meet additional standards for regulatory approval applicable to a traditional NDA submitted pursuant
to Section 505(b)(1). Moreover, even if the FDA does allow us to pursue the 505(b)(2) NDA pathway, depending on the product candidate,
we may still need to conduct additional clinical trials, including clinical trials to assess product safety or efficacy. If this were
to occur, the time and financial resources required to obtain FDA approval for our product candidates, and complications and risks associated
with our product candidates, would likely substantially increase.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
an inability to pursue the 505(b)(2) NDA pathway could result in new competitive products reaching the market more quickly than our product
candidates, which could hurt our competitive position and our business prospects. Even if we are allowed to pursue the 505(b)(2) NDA
pathway, we cannot assure that our product candidates will receive the requisite approvals for commercialization on a timely basis, if
at all. Other companies may achieve product approval of similar products before we do, which would delay our ability to obtain product
approval, and expose us to greater competition.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, notwithstanding the approval of a number of products by the FDA under 505(b)(2) over the last few years, some pharmaceutical
companies and others have objected to the FDA&#8217;s interpretation of 505(b)(2) of the FDCA to allow reliance on the FDA&#8217;s prior
findings of safety and effectiveness. If the FDA changes its interpretation of Section 505(b)(2), or if the FDA&#8217;s interpretation
of 505(b)(2) is successfully challenged in court it could delay or even prevent the FDA from approving any 505(b)(2) NDA that we submit
in the future. Moreover, the FDA has adopted an interpretation of the three-year exclusivity provisions whereby a 505(b)(2) application
can be blocked by exclusivity even if it does not rely on the previously-approved drug that has exclusivity (or any safety or effectiveness
information regarding that drug). Under the FDA&#8217;s interpretation, the approval of one or more of our product candidates may be
blocked by exclusivity awarded to a previously-approved drug product that shares certain innovative features with our product candidates,
even if our 505(b)(2) application does not identify the previously-approved drug product as a listed drug or rely upon any of its safety
or efficacy data. Any failure to obtain regulatory approval of our product candidates would significantly limit our ability to generate
revenues, and any failure to obtain such approval for all of the indications and labeling claims we deem desirable could reduce our potential
revenues.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if our product candidates are approved under 505(b)(2) regulatory pathway, the approval may be subject to limitations on the indicated
uses for which the products may be marketed, including more limited subject populations than we request, may require that contraindications,
warnings or precautions be included in the product labeling, including a black box warning, may be subject to other conditions of approval,
or may contain requirements for costly post-marketing clinical trials, testing and surveillance to monitor the safety or efficacy of
the products, or other post-market requirements, such as a REMS. The FDA also may not approve a product candidate with a label that includes
the labeling claims necessary or desirable for the successful commercialization of that product candidate.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Obtaining
and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining
regulatory approval of our product candidates in other jurisdictions.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we obtain and maintain regulatory approval of our product candidates in one jurisdiction, such approval does not guarantee that we
will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval
in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing
approval of a product candidate within the United States comparable regulatory authorities in foreign jurisdictions must also
approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions
and can involve requirements and administrative review periods different from those in the United States, including additional nonclinical
studies or clinical trials as investigations conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Obtaining
foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and
costs for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory
requirements in international markets and/or to receive applicable marketing approvals, our target market will be reduced and our ability
to realize the full market potential of our product candidates will be harmed.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
the acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA or applicable
foreign regulatory authority may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve
as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign
data alone unless (i) the data are applicable to the United States population and United States medical practice and (ii)
the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations. Additionally, the FDA&#8217;s
clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory
bodies have similar approval requirements. In addition, any foreign trials would be subject to the applicable local laws of the foreign
jurisdictions where the trials are conducted. There can be no assurance that the FDA or any applicable foreign regulatory authority will
accept data from trials conducted outside of the United States or the applicable jurisdiction.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may be unable to successfully complete our Phase 3 clinical trials for CTx-1301 or any future clinical trials for any other product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
conduct of a Phase 3 clinical trial is a complicated process. Although members of our management team have conducted Phase 3 clinical
trials in the past while employed at other companies, we as a company have not conducted a Phase 3 clinical trial before, and as a result
may require more time and incur greater costs than we anticipate. Failure to include the correct treatment regimen, complete, or delays
in, our Phase 3 clinical trials, could prevent us from or delay us in commencing future clinical trials for CTx-1301, obtaining regulatory
approval of and commercializing our product candidates, which would adversely impact our financial performance. In addition, some of
our competitors are currently conducting clinical trials for product candidates that treat the same indications as CTx-1301, and patients
who are otherwise eligible for our clinical trials may instead enroll in clinical trials of our competitors&#8217; product candidates.</FONT></P>

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enrollment is affected by other factors including:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">factors
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
recently announced a change in the clinical development plan for CTx-301 based on feedback from FDA, and accordingly stopped enrollment
in two Phase 3 trials of CTx-1301. We may need to restart these trials and/or start new trials in order to win regulatory approval of
CTx-1301. We may find it difficult or impossible to restart or start such clinical trials.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Even
if we obtain regulatory approval for CTx-1301, CTx-1302, and/or CTx-2103, such approval may be limited, and we will be subject to stringent,
ongoing government regulation</I></B>&#160;<B><I>.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if regulatory authorities approve CTx-1301, CTx-1302, and/or CTx-2103 for commercialization, the FDA could approve less than the full
scope of indications or labeling claims that we seek or may otherwise require special warnings or other restrictions on their use or
marketing. Regulatory authorities may limit the segments of the target population to which we or others may market CTx-1301, CTx-1302,
and/or CTx-2103 or limit the target population for our other product candidates. The advantages of CTx-1301, CTx-1302, and/or CTx-2103
may not be agreed to by the FDA or other regulatory authorities or such authorities may otherwise object to the inclusion of related
claims in product labeling or advertising and, as a result CTx-1301, CTx-1302, and/or CTx-2103 may not have our expected competitive
advantages when compared to other similar products. In particular, the FDA may limit labeling claims based upon the duration of
efficacy of our products. In addition, any new legislation addressing drug safety issues could result in delays in product development
or commercialization, or increased costs to assure compliance.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we obtain regulatory approval for any of our product candidates, activities such as the manufacturing processes, labeling, packaging,
distribution, adverse event reporting, storage, advertising, promotion and record keeping for the products will be subject to extensive
and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports,
registration, as well as continued compliance with cGMPs.
The FDA or comparable regulatory authorities may also impose requirements for costly post-marketing nonclinical studies or clinical trials
(often called &#8220;Phase 4 trials&#8221;) and post-marketing surveillance to monitor the safety or efficacy of the product. If we or
a regulatory authority discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
production problems or issues with the facility where the product is manufactured or processed, such as product contamination or significant
not-compliance with applicable cGMPs, a regulator may impose restrictions on that product, the manufacturing facility or us. Accordingly,
we and our CMOs will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made
in any NDA submission to the FDA or any other type of domestic or foreign marketing application. If we or our third-party providers,
including our CMOs fail to comply fully with applicable regulations, then we may be required to initiate a recall or withdrawal of our
products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency,
or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in the
following, among other things:</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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addition, the FDA&#8217;s or other regulatory authorities&#8217; policies may change and additional government regulations may be enacted
that could prevent, limit or delay regulatory approval of our drug candidates. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are otherwise not able to maintain regulatory compliance, we may
lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or
sustain profitability.</FONT></P>

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FDA&#8217;s policies may change, and additional government regulations may be enacted that could prevent, limit or delay marketing approval
of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements
or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which
would adversely affect our business, prospects and ability to achieve or sustain profitability.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
employees, independent contractors, principal investigators, consultants, vendors, CROs, CMOs and any partners with which we may collaborate
may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, CROs, CMOs,
and any partners with which we may collaborate may engage in fraudulent or other illegal activity. Misconduct by these persons could
include intentional, reckless or negligent conduct or unauthorized activity that violates laws or regulations, including those laws requiring
the reporting of true, complete and accurate information to the FDA or other regulatory authorities; manufacturing standards; federal,
state and foreign healthcare fraud and abuse laws; data privacy laws and regulations; or laws that require the true, complete and accurate
reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare industry
are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict
or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing and
promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve
the improper use or misrepresentation of information obtained in the course of clinical trials, or illegal misappropriation of drug product,
which could result in regulatory sanctions or other actions or lawsuits stemming from a failure to be in compliance with such laws or
regulations, and serious harm to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in
connection with government contracts and require certain contractors to maintain a code of business ethics and conduct. Additionally,
we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such
actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have
a material and adverse impact on our business, financial condition, results of operations and prospects including the imposition of civil,
criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, loss of eligibility to obtain marketing approvals
from the FDA, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages,
reputational harm, diminished profits and future earnings, additional reporting requirements if subject to a corporate integrity agreement
or other agreement to resolve allegations of non-compliance with any of these laws, and curtailment or restructuring of our operations,
any of which could adversely affect our ability to operate our business and our operating results.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may be required to modify our business practices, pay fines and significant expenses or experience other losses due to governmental investigations
or other enforcement activities.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may become subject to litigation or governmental investigations in the United States and/or foreign jurisdictions that may arise
from the conduct of our business. Like many companies in our industry, we may from time to time receive inquiries and subpoenas and other
types of information requests from government authorities and we may be subject to claims and other actions related to our business activities.</FONT></P>

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the ultimate outcome of investigations and legal proceedings are difficult to predict, adverse resolutions or settlements of those matters
could result in, among other things:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reputational
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">expenditure
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
we maintain insurance for certain risks, the amount of our insurance coverage may not be adequate to cover the total amount of all adverse
resolutions and settlements of claims and liabilities. It also is not possible to obtain insurance to protect against all potential risks
and liabilities.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
or our current and prospective partners may be subject to product recalls in the future that could harm our brand and reputation and
could negatively affect our business.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
or our current and prospective partners may be subject to product recalls, withdrawals or seizures if any of our product candidates,
if approved for marketing, fail to meet specifications or are believed to cause injury or illness or if we are alleged to have violated
governmental regulations including those related to the manufacture, labeling, promotion, sale or distribution. Any recall, withdrawal
or seizure in the future could materially and adversely affect consumer confidence in our brands and lead to decreased demand for our
approved products. In addition, a recall, withdrawal or seizure of any of our approved products would require significant management
attention, would likely result in substantial and unexpected expenditures and would harm our business, financial condition and operating
results.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
will need to obtain FDA approval of any proposed names for our product candidates that gain marketing approval, and any failure or delay
associated with such naming approval may adversely impact our business.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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name we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured a formal trademark
registration from the United States Patent and Trademark Office (&#8220;USPTO&#8221;). The FDA typically conducts a review
of proposed product names, including an evaluation of whether proposed names may be confused with other product names. The FDA may object
to any product name we submit if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed
product names, we may be required to adopt an alternative name for our product candidates, which could result in further evaluation of
proposed names with the potential for additional delays and costs.</FONT></P>

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at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain
or deploy key leadership and other personnel, or otherwise prevent new or modified products and services from being developed, approved
or commercialized in a timely manner, which could negatively impact our business.</I></B></FONT></P>

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ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding
levels, ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory, and policy changes and other
events that may otherwise affect FDA&#8217;s ability to perform routine functions. Average review times at the agency have fluctuated
in recent years as a result. In addition, government funding of other government agencies that fund research and development activities
is subject to the political process, which is inherently fluid and unpredictable.</FONT></P>

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at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved or cleared by necessary government
agencies, which would adversely affect our business. For example, over the last several years, the United States government has
shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical
activities.</FONT></P>

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response to the global pandemic of COVID-19 and public health emergency declarations in the United States, in March 2020, the FDA temporarily
postponed most inspections of foreign manufacturing facilities and products, postponed routine surveillance inspections of domestic manufacturing
facilities and provided guidance regarding the conduct of clinical trials. The FDA utilized a rating system to assist it in determining
when and where it was safest to conduct such inspections based on data about the virus&#8217;s trajectory in a given state and locality
and the rules and guidelines that were put in place by state and local governments. The FDA used similar data to inform resumption of
prioritized operations abroad.</FONT></P>

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a prolonged government shutdown or slowdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from
conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or
other regulatory authorities to timely review and process regulatory submissions, which could have a material adverse effect on our business.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens
and other risks and uncertainties.</I></B></FONT></P>

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future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend
to rely on collaborations with third parties. If we commercialize our other product candidates in foreign markets, we would be subject
to additional risks and uncertainties, including:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">foreign
    currency exchange rate fluctuations; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Foreign
sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability,
trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>A
pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, could cause a disruption to the development of our product
candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Public
health crises such as pandemics or similar outbreaks could adversely impact our business. In December 2019, COVID-19 spread worldwide. The coronavirus pandemic led to the implementation of various responses, including government-imposed quarantines,
travel restrictions and other public health safety measures. The extent to which a pandemic, epidemic or outbreak of an infectious disease
impacts our operations or those of our third-party partners, including our development studies or clinical trial operations, will depend
on future occurrences, which are highly uncertain and cannot be predicted with confidence, including the duration of any outbreak and
the actions to contain or treat its impact, among others. Although the majority of our operations are conducted in the United States,
the spread of an infectious disease globally could adversely impact our product candidate development or clinical trial operations in
the United States and abroad. Any negative impact infectious diseases have on patient enrollment or treatment or the execution of our
product candidates could cause costly delays to clinical trial activities, which could adversely affect our ability to obtain regulatory
approval for and to commercialize our product candidates, increase our operating expenses, and have a material adverse effect on our
financial results.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Some
factors that may delay or otherwise adversely affect enrollment in the clinical trials of our product candidates, as well as our business
generally, in the event of a pandemic, epidemic or outbreak of an infectious disease include:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">diversion
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    sites and hospital staff supporting the conduct of our clinical trials;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    federal or state governments, employers and others, or interruption of clinical trial participant visits and study procedures, the
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">risk
    that participants enrolled in our clinical trials will acquire an infectious disease while the clinical trial is ongoing, which could
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">limitations
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Commercialization</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Recently
enacted and future policies and legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize
our product candidates and may affect the reimbursement made for any product candidate for which we receive marketing approval.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Legislative
and regulatory actions affecting government prescription drug procurement and reimbursement programs occur relatively frequently. In
the United. States, for example, the Patient Protection and Affordable Care Act (&#8220;PPACA&#8221;) was enacted in 2010 to expand
healthcare coverage and made significant changes to drug reimbursement. Other legislative changes that affect the pharmaceutical industry
have been proposed and adopted in the United States since PPACA was enacted. For example, the Inflation Reduction Act of 2022 included,
among other things, a provision that authorizes Centers for Medicare and Medicaid Services (&#8220;CMS&#8221;) to negotiate a
&#8220;maximum fair price&#8221; for a limited number of high-cost, single-source drugs every year, and another provision that requires
drug companies to pay rebates to Medicare if prices rise faster than inflation. Complying with any new legislation could be time-intensive
and expensive, resulting in a material adverse effect on our business.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, many states have proposed or enacted legislation that seeks to indirectly or directly regulate pharmaceutical drug
pricing, such as by requiring biopharmaceutical manufacturers to publicly report proprietary pricing information or to place a
maximum price ceiling on pharmaceutical products purchased by state agencies. For example, in 2017, California&#8217;s governor
signed a prescription drug price transparency state bill into law, requiring prescription drug manufacturers to provide advance
notice and explanation for price increases of certain drugs that exceed a specified threshold. Both Congress and state legislatures
are considering various bills that would reform drug purchasing and price negotiations, allow greater use of utilization management
tools to limit Medicare Part D coverage, facilitate the import of lower-priced drugs from outside the United States and encourage the use of generic drugs. Such initiatives and legislation may cause added pricing pressures on our
products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Changes
to the Medicaid program at the federal or state level could also have a material adverse effect on our business. Proposals that could
impact coverage and reimbursement of our products, including giving states more flexibility to manage drugs covered under the Medicaid
program and permitting the re-importation of prescription medications from Canada or other countries, could have a material adverse effect
by limiting our products&#8217; use and coverage. Furthermore, state Medicaid programs could request additional supplemental rebates
on our products as a result of an increase in the federal base Medicaid rebate. To the extent that private insurers or managed care programs
follow Medicaid coverage and payment developments, they could use the enactment of these increased rebates to exert pricing pressure
on our products, and the adverse effects may be magnified by their adoption of lower payment schedules.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We cannot predict the likelihood,
nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the
United States or abroad. We expect that additional state and federal health care reform measures will be adopted in the future, any of
which could limit the amounts that federal and state governments will pay for health care products and services. Moreover, the Biden
Administration, including the Secretary of the United States Department of Human and Health Services, has indicated that lowering
prescription drug prices is a priority, but we do not yet know what steps the administration will take or whether such steps will be
successful.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Other proposed regulatory actions
affecting manufacturers could have a material adverse effect on our business. It is difficult to predict the impact, if any, of any such
proposed legislative and regulatory actions or resulting state actions on the use and reimbursement of our products in the United
States, but our results of operations may be adversely affected.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Unfavorable
pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business in the future.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is increasing pressure on pharmaceutical companies to reduce healthcare costs. In the United States, these pressures come from a variety
of sources, such as managed care groups and institutional and government purchasers. Increased purchasing power of entities that negotiate
on behalf of federal healthcare programs and private sector beneficiaries could increase pricing pressures in the future. Such pressures
may also increase the risk of litigation or investigation by the government regarding pricing calculations. The pharmaceutical industry
will likely face greater regulation and political and legal actions in the future.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Adverse
pricing limitations may hinder our ability to recoup our investment in one or more future product candidates, even if our future product
candidates obtain regulatory approval. Adverse pricing limitations prior to approval will also adversely affect us by reducing our commercial
potential. Our ability to commercialize any potential products successfully also will depend in part on the extent to which coverage
and reimbursement for these products and related treatments becomes available from third-party payors, including government health administration
authorities, private health insurers and other organizations. Third-party payors decide which medications they will pay for and establish
reimbursement levels. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical products, will apply to
companion diagnostics.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
significant trend in the United States healthcare industry and elsewhere is cost containment. Third-party payors have attempted
to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are
requiring that companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical
products. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize in the future and,
if reimbursement is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any
product for which we obtain marketing approval in the future. If reimbursement is not available or is available only to limited levels,
we may not be able to successfully commercialize any product candidate that we successfully develop.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
may be significant delays in obtaining reimbursement for approved products, and coverage may be more limited than the purposes for which
the product is approved by the FDA or regulatory authorities in other countries. Moreover, eligibility for reimbursement does not imply
that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale
and distribution. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made
permanent. Payment rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments
allowed for lower cost products that are already reimbursed and may be incorporated into existing payments for other services. Net prices
for products may be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation of laws that
presently restrict imports of products from countries where they may be sold at lower prices than in the United States. Third-party payors
often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but also have their own
methods and approval process apart from Medicare coverage and reimbursement determinations. Accordingly, one third-party payor&#8217;s
determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Our inability
to promptly obtain coverage and adequate reimbursement from third-party payors for approved products could have a material adverse effect
on our operating results, our ability to raise capital needed to commercialize potential products and our overall financial condition.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates
or indications that may be more profitable or for which there is a greater likelihood of success.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
we have limited financial and management resources, we focus on development programs and product candidates that we identify for specific
indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that
later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial
drugs or profitable market opportunities. Our spending on current and future research and development programs and product candidates
for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or
target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration,
licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and
commercialization rights to such product candidate.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>The
commercial success of our product candidates, if approved, depends partially upon attaining market acceptance by physicians, patients,
third-party payors, and the medical community.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to generate product revenue will depend significantly on our ability to successfully obtain final marketing approval for and
commercialize our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if any of our product candidates CTx-1301, CTx-1302, and/or CTx-2103 obtain regulatory approval, they may not gain sufficient market
acceptance among physicians, patients, third-party payors, and the healthcare community. Failure to achieve market acceptance would limit
our ability to generate revenue and would affect our results of operations. The degree of market acceptance of CTx-1301, CTx-1302, and/or
CTx-2103 will depend on many factors, including:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    efficacy and potential advantages of CTx-1301, CTx-1302, and/or CTx-2103 and compared to alternative treatments or competitive products;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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</TABLE>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability to manufacture all our products CTx-1301, CTx-1302 as well as CTx-2103 in sufficient quantities and yields;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">perceptions
    of physicians, patients and the healthcare community, including third-party payors, regarding the safety, efficacy and potential
    benefits of CTx-1301, CTx-1302 and/or CTx-2103 compared to competing products or therapies;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    timing of any such marketing approval in relation to other product approvals;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">any
    restrictions on concomitant use of other medications;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">support
    from patient advocacy groups;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">relative
    convenience and ease of administration compared to alternative treatments; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    availability of adequate coverage and reimbursement from governmental health programs and third-party payors and pricing relative
    to other competing products and therapies.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 31.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
our drug candidates are approved but fail to achieve an adequate level of acceptance by key market participants, we will not be able
to generate significant revenues, and we may not become or remain profitable, which may require us to seek additional financing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 31.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to negotiate, secure and maintain third-party coverage and reimbursement for our product candidates may be affected by political,
economic and regulatory developments in the United States and other jurisdictions. Governments continue to impose cost containment measures,
and third-party payors are increasingly challenging prices charged for medicines and examining their cost effectiveness, in addition
to their safety and efficacy. These and other similar developments could significantly limit the degree of market acceptance of any product
candidate of ours that receives marketing approval in the future.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may face significant competition from other pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
pharmaceutical industry is intensely competitive and subject to rapid and significant technological change. If we fail to stay at the
forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors
may render our technologies or product candidates obsolete, less competitive or not economical.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect to have competitors both in the United States and internationally, including major multinational pharmaceutical companies. For
example, amphetamine XR is currently marketed in the United States by Shire under the brand name Adderall XR, and methylphenidate is
marketed in the United States by Janssen under the brand name Concerta, and by Novartis under the brand names Focalin XR and Ritalin
LA. Further, makers of branded drugs could also enhance their own formulations in a manner that competes with our enhancements of these
drugs. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development
staff and more experienced marketing and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical
industries may result in even more resources being concentrated in our competitors. As a result, these companies may obtain regulatory
approval more rapidly than we are able and may be more effective in selling and marketing their products as well. Smaller or early-stage
companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of
capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis drug
products or drug delivery technologies that are more effective or less costly than our PTR platform, or any product candidate that we
are currently developing or that we may develop. In addition, our competitors may file citizens petitions with the FDA in an attempt
to persuade the FDA that our products, or clinical trials that support their approval, contain deficiencies or that new regulatory requirements
be placed on the product candidate or drug class of the product candidate. Such actions by our competitors could delay or even prevent
the FDA from approving any NDA that we submit under Section 505(b)(2).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we are successful in achieving regulatory approval to commercialize a product candidate ahead of our competitors, our future pharmaceutical
products may face direct competition from generic and other follow-on drug products. Any of our product candidates that may achieve regulatory
approval in the future may face competition from generic products earlier or more aggressively than anticipated, depending upon how well
such approved products perform in the United States prescription drug market. Our ability to compete also may be affected in many cases
by insurers or other third-party payors seeking to encourage the use of generic products. Generic products are expected to become available
over the coming years. Even if our product candidates achieve marketing approval, they may be priced at a significant premium over competitive
generic products, if any have been approved by then.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to creating the 505(b)(2) NDA pathway, the Hatch-Waxman Amendments to the FDCA authorized the FDA to approve generic
drugs that are the same as drugs previously approved for marketing under the NDA provisions of the statute pursuant to Approved Abbreviated
New Drug Applications (&#8220;ANDAs&#8221;). An ANDA relies on the preclinical and clinical testing conducted for a previously approved
reference listed drug (&#8220;RLD&#8221;) and must demonstrate to the FDA that it is &#8220;bioequivalent&#8221; to the RLD. The
FDA is prohibited by statute from approving an ANDA when certain marketing or data exclusivity protections apply to the RLD. If any such
competitor or third party is able to demonstrate bioequivalence without infringing our patents, then this competitor or third party may
then be able to introduce a competing generic product onto the market.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe that our ability to successfully compete will depend on, but is not limited to:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    efficacy and safety of our product and product candidates, including as relative to marketed products and product candidates in development
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability to commercialize and market any of our product candidates that receive regulatory approval;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">whether
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability to protect intellectual property rights related to our product and product candidates;</FONT></TD></TR>

<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    ability to manufacture on a cost-effective basis and sell commercial quantities of our product and product candidates that receive
    regulatory approval; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">acceptance
    of any of our products and product candidates that receive regulatory approval by physicians and other healthcare providers.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
our competitors market products that are more effective, safer or less expensive than our product, if any, or that reach the market sooner
than our products, if any, we may enter the market too late in the cycle and may not achieve commercial success, or we may have to reduce
our price, which would impact our ability to generate revenue and obtain profitability.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, successful commercialization will also depend on whether we can adequately protect against and effectively respond to any claims
by holders of patents and other intellectual property rights that our products infringe their rights, whether any unanticipated adverse
effects or unfavorable publicity develops in respect of our products, as well as the emergence of new or existing products as competition,
which may be proven to be more clinically effective and cost-effective. If we are unable to successfully complete these tasks, we may
not be able to commercialize in a timely manner, or at all, in which case we may be unable to generate sufficient revenues to sustain
and grow our business.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot predict the interest of potential follow-on competitors or how quickly others may seek to come to market with competing products,
whether approved as a direct ANDA competitor or as a 505(b)(2) NDA referencing one of our future drug products. If the FDA approves generic
versions of our drug candidates in the future, should they be approved for commercial marketing, such competitive products may be able
to immediately compete with us in each indication for which our product candidates may have received approval, which could negatively
impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on our investments in
those product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Social
issues around the abuse of opioids and stimulants, including law enforcement concerns over diversion and regulatory efforts to combat
abuse, could decrease the potential market for our product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Media
stories regarding prescription drug abuse and the diversion of opioids, stimulants, and other controlled substances are commonplace.
Law enforcement and regulatory agencies may apply policies that seek to limit the availability of opioids and stimulants. Such efforts
may inhibit our ability to commercialize our product candidates. Aggressive enforcement and unfavorable publicity regarding opioid drugs,
the limitations of abuse-deterrent formulations, public inquiries and investigations into prescription drug abuse, litigation or regulatory
activity, sales, marketing, distribution or storage of our products could harm our reputation. Such negative publicity could reduce the
potential size of the market for our product candidates and decrease the revenue we are able to generate from their sale, if approved.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additionally,
current and future efforts by Congress, state legislatures, the FDA and other regulatory bodies to combat abuse of opioids and stimulants
may negatively impact the market for our product candidates. It is possible that lawmakers or the FDA will announce new legislation or
regulatory initiatives at any time that may increase the regulatory burden or decrease the commercial opportunity for our product candidates.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Our Dependence on Third Parties</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we fail to produce our product or product candidates in the volumes that are required on a timely basis, or fail to comply with stringent
regulations applicable to pharmaceutical drug manufacturers, we may face regulatory penalties and delays in the development and commercialization
of our product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
currently depend on third-party suppliers for the supply of the APIs and excipients for our product candidates. Any shortages
in the availability of raw materials could result in production or other delays with consequent adverse effects on us. In addition, because
regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material suppliers may
result in production delays or higher raw material costs. Any such delays could trigger penalties, which would have a negative impact
on our business. If our raw material manufacturers were to encounter difficulties or otherwise fail to comply with their obligations
to us, our ability to obtain FDA approval and market our product and product candidates would be jeopardized. In addition, any delay
or interruption in the supply of clinical trial supplies could delay or prohibit the completion of our bioequivalence and/or clinical
trials, increase the costs associated with conducting our bioequivalence and/or clinical trials and, depending upon the period of delay,
require us to commence new trials at significant additional expense or to terminate a trial.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of advanced manufacturing
techniques and process controls. Pharmaceutical companies may encounter difficulties in manufacturing scale up of production. These problems
include manufacturing difficulties relating to production costs and yields, quality control, including stability of the product and quality
assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations. We may also need
to purchase additional equipment, some of which can take several months or more to procure, setup and validate, and increase our software
and computing capacity to meet increased demand. Failure to manage this growth or transition could result in turnaround time delays,
higher product costs, declining product quality, or slower responses to competitive challenges. A failure in any one of these areas could
make it difficult for us to meet market expectations for our products and could damage our reputation and the prospects for our business.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Manufacturers
of pharmaceutical products need to comply with cGMP requirements enforced by the FDA through the agency&#8217;s facility inspection programs.
The cGMP requirements include, among other things, quality control, quality assurance, the maintenance of records and documentation,
and the obligation to investigate and correct any deviations from regulatory requirements. A failure to comply with these requirements
may result in fines and civil penalties, suspension of production, suspension or delay in product approval, product seizure or voluntary
recall, or withdrawal of product approval. If the safety of any of our products or product candidates is compromised due to failure to
adhere to applicable laws or for other reasons, we may not be able to obtain, or to maintain once obtained, regulatory approval for such
product candidate or successfully commercialize such products or product candidates, and we may be held liable for any injuries sustained
as a result. Any of these factors could cause a delay in clinical developments, regulatory submissions, approvals or commercialization
of our products or product candidates, entail higher costs or result in our being unable to effectively commercialize our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
rely on limited sources of supply for CTx-1301 and/or CTx-1302 as these are scheduled products, and any disruption in the chain
of supply may impact production and sales of CTx-1301 and/or CTx-1302 and cause delays in developing and commercializing
our product candidates. </I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">The NDAs we plan to submit for
CTx-1301 and/or CTx-1302 will include our proposed manufacturing process for each product candidate. Any change to our manufacturing
process, facilities or suppliers could require that we amend our NDA. Any change to our manufacturing process, facilities or suppliers
could require that we amend our NDA. Also, because of our proprietary processes for manufacturing our product candidates, we cannot immediately
transfer manufacturing activities for our drug products to an alternate supplier, and a change of manufacturing facilities would be time-
consuming and could be a costly endeavor. For example, in October 2022, we announced a new CMO. The CTx-1301 fixed-dose study was delayed
while the manufacturing process with the new CMO was established to manufacture the final dosage strengths needed for the fixed-dose
study. Potential future changes in manufacturing facilities would also require us to supplement our NDA filings to include the
change of manufacturing site. Identifying an appropriately qualified source of alternative supply for any one or more of the component
substances for our product candidates or product could be time consuming, and we may not be able to do so without incurring material
delays in the development and commercialization of our product candidates. Any alternative vendor would also need to be qualified through
an NDA supplement and may need to undergo an FDA inspection before the supplement can be approved, which could result in further delay,
including delays related to additional clinical trials.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates,
cause us to incur higher costs and prevent us from commercializing them successfully. Furthermore, if our suppliers fail to deliver the
required commercial quantities of components and APIs on a timely basis and at commercially reasonable prices, including if our suppliers
did not receive adequate DEA quotas for the supply of certain scheduled components, and we are unable to secure one or more replacement
suppliers capable of production at a substantially equivalent cost, commercialization of our product candidates, and clinical trials
of future potential product candidates, may be delayed or we could lose potential revenue and our business, financial condition, results
of operation and reputation could be adversely affected.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
rely and expect to continue to rely completely on third parties to formulate and manufacture our preclinical, clinical trial and commercial
drug supplies. The development and commercialization of any of our drug candidates could be stopped, delayed or made less profitable
if those third parties fail to provide us with sufficient quantities of such drug supplies or fail to do so at acceptable quality levels,
including in accordance with applicable regulatory requirements or contractual obligations, and our operations could be harmed as a result.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not currently have, nor do we plan to acquire, the infrastructure or capability internally, such as our own manufacturing facilities,
to manufacture our preclinical and clinical drug supplies for our clinical trials and preclinical studies or commercial quantities of
any drug candidates that may obtain regulatory approval. We procure bulk drug substance from a sole source, third-party supplier and
have contracted with a CMO to produce our drug candidates at its facilities, and we anticipate that we will continue to do so for the
foreseeable future. Therefore, we lack the resources and expertise to formulate or manufacture our own drug candidates, and our reliance
on third parties increases the risk that we will not have sufficient quantities of bulk drug substances or our product candidates, in
such quantities at an acceptable cost, which could delay, prevent or impair our ability to timely conduct our clinical trials or our
other development or commercialization efforts. For example, we experienced delays in the manufacturing and delivery of clinical supply
for the CTx-1301 fixed-dose study due to operational resource issues at our former CMO. The manufacture of the clinical supply was further
delayed while our new CMO establishes its manufacturing process for CTx-1301.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have entered into an agreement with a CMO and intend for that CMO to manufacture all clinical, registration and commercial batches of
our drug candidate, CTx-1301, and we plan to enter into agreements with one or more manufacturers to manufacture, supply, store, and
distribute drug supplies for our future clinical trials and/or commercial sales. We intend to establish or continue those relationships
for the supply of our drug candidates; however, there can be no assurance that we will be able to retain those relationships on commercially
reasonable terms, if at all. If we are unable to maintain those relationships, we could experience delays in our development efforts
as we locate and qualify new CMOs. If any of our current drug candidates or any drug candidates we may develop or acquire in the future
receives regulatory approval, we will rely on one or more CMOs to manufacture the commercial supply of such drugs.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if we are able to maintain our existing third-party relationships or establish any such agreements with other third-party manufacturers,
reliance on third-party manufacturers entails additional risks, including, but not limited to:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    and costs associated with changing suppliers, including additional regulatory filings;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    possible breach, termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to
    secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely
    fashion, in sufficient quantities or under acceptable terms.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Each
of these risks could delay our clinical trials, the approval, if any, of our drug candidates or the commercialization of our drug candidates,
could result in higher costs or could deprive us of potential product revenues. Some of these events could be the basis for FDA action,
including injunction, recall, seizure or total or partial suspension of production.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">While
we are ultimately responsible for the manufacture of our product candidates, we do not manufacture our products ourselves and are dependent
on our CMOs for compliance with cGMPs. Our agreements with our CMOs require them to perform according to certain cGMP requirements
such as those relating to quality control, quality assurance and qualified personnel, but we cannot control the conduct of our CMOs to
implement and maintain these standards. If our CMOs cannot successfully manufacture material that conforms to our specifications and
the strict regulatory requirements of the FDA or other regulatory authorities, we would be prevented from obtaining regulatory approval
for our drug candidates unless and until we engage a substitute CMO that can comply with such requirements, which we may not be able
to do. Any such failure by any of our CMOs would significantly impact our ability to develop, obtain marketing approval for or market
our product candidates, if approved.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Further,
if our product candidates are approved, our suppliers will be subject to regulatory requirements, covering manufacturing, testing, quality
control and record keeping relating to our product candidates, and subject to ongoing inspections by the regulatory agencies. Failure
by any of our suppliers to comply with applicable regulations may result in long delays and interruptions to our manufacturing capacity
while we seek to secure another supplier that meets all regulatory requirements, as well as market disruption related to any necessary
recalls or other corrective actions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Third-party
manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure,
or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us,
including warning letters, clinical holds or termination of clinical trials, fines, injunctions, restitution, disgorgement, civil penalties,
delays, suspension or withdrawal of approvals or other permits, FDA refusal to approve pending applications, product detentions, FDA
consent decrees placing significant restrictions on or suspending manufacturing and distribution operations, debarment, refusal to allow
import or export, product detentions, adverse publicity, dear-health-care-provider letters or other warnings, license revocation, seizures
or recalls of product candidates, operating restrictions, refusal of government contracts or future orders under existing contracts and
civil and criminal liability, including False Claims Act liability, exclusion from participation in federal health care programs, and
corporate integrity agreements among other consequences, any of which could significantly and adversely affect supplies of our products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Failure
by our third-party contract manufacturer to maintain DEA regulations as pertain to controlled substances may cause their license to be
revoked and production of our products and product candidates may be interrupted or stopped. This would impact our ability to develop,
obtain marketing approval for or market our product candidates, if approved.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
product candidates and any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing
facilities, and we may be unable to obtain access to these facilities on favorable terms.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are a limited number of manufacturers that operate under cGMP regulations and possess a DEA license to procure, hold and work with controlled
substances. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing
approval. We do not currently have arrangements in place for redundant supply or a second contract manufacturer. If our current contract
manufacturer cannot perform as agreed, we may be required to replace such manufacturer and we may incur added costs and delays in identifying
and qualifying any such replacement. For example, we experienced delays in the manufacturing and delivery of clinical supply for the
CTx-1301 fixed-dose study due to operational resource issues at our former CMO. The manufacture of the clinical supply was further delayed
while our new CMO establishes its manufacturing process for CTx-1301.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
expect to rely on third parties to conduct our clinical trials and our regulatory submissions for our product candidates, and those third
parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials and/or regulatory submissions.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect to engage CROs for our planned clinical trials and our regulatory submissions of our product candidates. We expect to rely on
CROs, as well as other third parties, such as clinical data management organizations, regulatory strategists, medical institutions and
clinical investigators, to conduct our planned clinical trials, prepare the appropriate regulatory submissions for our product candidates,
and assist with ensuring compliance with applicable regulatory requirements. Agreements with such third parties might terminate for a
variety of reasons, including a failure to perform by the third parties. If we need to enter into alternative arrangements, our drug
development activities would be delayed.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
reliance on these third parties for clinical development activities may reduce our control over these activities but will not relieve
us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance
with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with regulatory standards,
commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure
that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are
protected. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial
sites. We also are required to register specified ongoing clinical trials and post the results of completed clinical trials on a government-sponsored
database, ClinicalTrials.gov, within specified timeframes. In addition, we must conduct our clinical trials with product produced under
cGMP requirements. Failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory
approval process. Failure to comply with the applicable requirements related to clinical investigations by us, our CROs or clinical trial
sites can also result in clinical holds and termination of clinical trials, debarment, FDA refusal to approve applications based on the
clinical data, warning letters, withdrawal of marketing approval if the product has already been approved, fines and other monetary penalties,
delays, adverse publicity and civil and criminal sanctions, among other consequences.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do
not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory
requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product
candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and
may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result
in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation
of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical
trial itself may be jeopardized, which could result in the delay or rejection of any NDA we submit by the FDA. Any such delay or rejection
could prevent us from commercializing our product candidates. Further, our arrangements with principal investigators are also subject
to scrutiny under other health care regulatory laws, such as the federal Anti-Kickback Statute.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
also expect to rely on other third parties to store and distribute product supplies for our clinical trials. Any performance failure
or noncompliance with applicable regulatory requirements, including those of the FDA or DEA, on the part of our distributors could delay
clinical development or marketing approval of our product candidates or commercialization of our products, producing additional losses
and depriving us of potential product revenue.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
the third parties with whom we contract do not successfully carry out their contractual duties or obligations or meet expected deadlines
or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols
or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated, we may need to conduct additional
trials, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, the
commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be
delayed. To the extent we are unable to successfully identify and manage the performance of third-party service providers in the future,
our business may be adversely affected.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
depend on collaborations with third parties for the development and commercialization of our product candidates. If those collaborations
are not successful, we may not be able to capitalize on the market potential of these product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; background-color: white">On
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">March 7, 2023<FONT STYLE="background-color: white">,
we entered into a Joint Commercialization Agreement (the &#8220;Commercialization </FONT>Agreement<FONT STYLE="background-color: white">&#8221;)
with Indegene, Inc. (&#8220;</FONT>Indegene<FONT STYLE="background-color: white">&#8221;).</FONT></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the Commercialization Agreement, Indegene will provide us with commercialization services for CTx-1301, including services related
to (a) medical affairs &amp; pharmacovigilance; (b) pricing, reimbursement and market access; (c) commercial operations; and (d) marketing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may also seek additional third-party collaborators for the development and commercialization of our product candidates, including
for the commercialization of any of our product candidates that are approved for marketing outside the United States. Potential collaborators
include co-commercialization partners, as well as regional, national and international large and mid-size pharmaceutical companies.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may have limited control over the amount and timing of resources that our current and any future collaborators dedicate to the development
or commercialization of our product candidates. Our ability to generate revenue from these arrangements will depend on our collaborators&#8217;
abilities to successfully perform the functions assigned to them in these arrangements. Pursuant to the Commercialization Agreement,
we and Indegene will enter into statements of work that will set forth, among other things, the services to be performed by Indegene,
the deliverables for such services and the fees to be paid by us. We may be unable to negotiate the terms of the statements of work,
including the services to be performed by Indegene or the fees payable by us, on terms acceptable to us, or at all. If we are unable
to do so, we will have to seek other collaborations for the commercialization of CTx-1301, which may delay commercialization.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
current collaborations pose, and any future collaborations involving our product candidates would pose the following risks, including
but not limited to:</FONT></P>

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Commercialization Agreement and any future collaboration agreements may not lead to development or commercialization of product candidates
in the most efficient manner or at all. If a present or future collaborator of ours were to be involved in a business combination, the
continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished or terminated.</FONT></P>

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development of our product candidates and clinical programs and the potential commercialization will require substantial additional capital.
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companies for the development and/or commercialization of those product candidates.</FONT></P>

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face significant competition in seeking appropriate collaborators. Whether we reach additional definitive agreements for a collaboration
will depend, among other things, upon our assessment of the collaborator&#8217;s resources and expertise, the terms and conditions of
the proposed collaboration and the proposed collaborator&#8217;s evaluation of a number of factors. Those factors may include the design
or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the
potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate
to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can
exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally.
The collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate
on and whether such a collaboration could be more attractive than the one with us for our product candidate.</FONT></P>

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to be performed by Indegene, the deliverables for such services and the fees to be paid by us. We may be unable to negotiate the terms
of the statements of work, including the services to be performed by Indegene or the fees payable by us, on terms acceptable to us, or
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may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have
to curtail the development of product candidates, reduce or delay one or more of our development programs, delay potential commercialization
or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization
activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own,
we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all. If we do not have sufficient
funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.</FONT></P>

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rely on third parties to perform many essential services for any products that we commercialize, including distribution, customer service,
accounts receivable management, cash collection and adverse event reporting. If these third parties fail to perform as expected or to
comply with legal and regulatory requirements, our ability to commercialize CTx-1301, CTx-1302, and/or CTx-2103 will be significantly
impacted and we may be subject to regulatory sanctions.</I></B></FONT></P>

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may retain additional third-party service providers to perform a variety of functions related to the sale and distribution of any or
all of our products, including CTx-1301, CTx-1302, and CTx-2103, if approved, key aspects of which will be out of our direct control.
These service providers may provide key services related to distribution, customer service, accounts receivable management and cash collection.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
will substantially rely on Indegene and will substantially rely on any future third-party providers to perform services for us. If these
third-party service providers fail to comply with applicable laws and regulations, fail to meet expected deadlines, or otherwise do not
carry out their contractual duties to us, our ability to deliver product to meet commercial demand may be significantly impaired. In
addition, we may engage third parties to perform various other services for us relating to adverse event reporting, safety database management,
fulfillment of requests for medical information regarding our product candidates and related services. If the quality or accuracy of
the data maintained by these service providers is insufficient or if they fail to comply with various requirements, we could be subject
to regulatory sanctions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we are unable to achieve and maintain adequate levels of coverage and reimbursement for our product or product candidates, if approved,
their commercial success may be severely hindered.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Successful
sales of our product and any product candidates that receive regulatory approval depend on the availability of adequate coverage and
reimbursement from third-party payors. Patients who are prescribed medications for the treatment of their conditions generally rely on
third-party payors to reimburse all or part of the costs associated with their prescription drugs. Adequate coverage and reimbursement
from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Coverage
decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic
alternatives are already available or subsequently become available. Assuming we obtain coverage for a given product, the resulting reimbursement
payment rates might not be adequate or may require co-payments that patients find unacceptably high. Patients are unlikely to use our
products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, the market for CTx-1301, CTx-1302, and CTx-2103 will depend significantly on access to third-party payors&#8217; drug formularies
or lists of medications for which third-party payors provide coverage and reimbursement. The industry competition to be included in such
formularies often leads to downward pricing pressures on pharmaceutical companies. Also, third-party payors may refuse to include a particular
branded drug in their formularies or otherwise restrict patient access through formulary controls or otherwise to a branded drug when
a less costly generic equivalent or other alternative is available.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Third-party
payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling
healthcare costs. In addition, in the United States, no uniform policy requirement for coverage and reimbursement for drug products exists
among third-party payors. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a
result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and
clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will
be applied consistently or obtained in the first instance.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Further,
we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the United States and in international
markets. Third party coverage and reimbursement for our product candidates for which we may receive regulatory approval may not be available
or adequate in either the United States or international markets, which could have a material adverse effect on our business, results
of operations, financial condition and prospects.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Third-party
payors may not adequately cover or reimburse consumers for the purchase of our products.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
future revenues and ability to generate positive cash flow from operations may be affected by the continuing efforts of governments and
third-party payors to contain or reduce the costs of healthcare through various means. In certain foreign markets, the pricing of prescription
pharmaceuticals is subject to governmental control. In the United States, there has been, and we expect that there will continue to be,
a number of federal and state proposals to implement similar governmental controls. We cannot be certain what legislative proposals will
be adopted or what actions federal, state or private payors for healthcare goods and services may take in response to any drug pricing
reform proposals or legislation. Such reforms may make it difficult to complete the development and testing of our products, and therefore
may limit our ability to generate revenues from sales and achieve profitability. Further, to the extent that such reforms may affect
our business and collaborators, our ability to commercialize our products may be harmed.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the United States and elsewhere, sales of prescription pharmaceutical products still depend in large part on the availability of reimbursement
to the consumer from third-party payors, such as governmental and private insurance plans. Third-party payors are increasingly challenging
the prices charged for medical products. The market for CTx-1301, CTx-1302, and/or CTx-2103 will depend significantly on whether third-party
payors provide coverage and reimbursement. Industry competition to be eligible for reimbursement often leads to downward pricing pressures
on pharmaceutical products. Also, third-party payors may refuse to reimburse for a particular branded drug or product when a less costly
generic equivalent or other alternative is available. In the United States, no uniform policy of coverage and reimbursement for drug
products exists among third-party payors. Because each third-party payor individually approves coverage and reimbursement levels, obtaining
coverage and adequate reimbursement is a time-consuming and costly process. We would be required to provide scientific and clinical support
for the use of our products to each third-party payor separately with no assurance that approval would be obtained. This process could
delay the market acceptance of our products and could have a negative effect on our future revenues and operating results. Even if we
succeed in bringing CTx-1301, CTx-1302 and/or CTx-2103 to market, we cannot be certain that it would be considered cost effective or
that coverage and adequate reimbursement to patients would be available. Patients may be unlikely to use CTx-1301, CTx-1302 and/or CTx-2103
unless coverage is provided, and reimbursement is adequate to cover a significant portion of its cost.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, in many foreign countries, particularly countries within the European Union, the pricing of prescription drugs is subject
to government control. In some jurisdictions outside the United States, the proposed pricing for a drug must be approved before it may
be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides
options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement
and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product,
or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on
the market. Moreover, pricing negotiations with governmental authorities in these countries can take considerable time after the receipt
of marketing approval for a product. To obtain reimbursement or pricing approval in countries outside of the United States, we
may be required to conduct additional clinical trials that specifically compares the cost-effectiveness of our products
CTx-1301, CTx-1302, and/or CTx-2103 to other available therapies. We may face competition for CTx-1301 and/or CTx-1302 from lower-priced
products in foreign countries that have placed price controls on pharmaceutical products. In addition, there may be foreign products
imported that compete with CTx-1301, CTx-1302, and/or CTx-2103, which could negatively impact our profitability.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe CTx-1301, CTx-1302, and CTx-2103 will need to be priced competitively with current therapies to be eligible for full reimbursement
in the United States and international markets. If we are unable to obtain coverage of, and adequate payment levels for, CTx-1301, CTx-1302,
and/or CTx-2103 from third-party payors, physicians may limit how much or under what circumstances they will prescribe it and patients
may decline to purchase it. This in turn could affect our ability to successfully commercialize any or all of our products and harm our
business.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we are unable to support demand for CTx-1301, CTx-1302, and/ or CTx-2103, and any future product candidates, including ensuring that
we have adequate capacity to meet increased demand, or we are unable to successfully manage the evolution of our drug delivery technology
platform, our business could suffer.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
our volume grows, we will need to extend our platform to support product production at a larger scale within expected turnaround times.
We may need additional certified laboratory scientists and technical and manufacturing personnel to process higher volumes of CTx-1301,
CTx-1302, and/ or CTx-2103, if approved. We may also need to purchase additional equipment, some of which can take several months or
more to procure, setup and validate. There is no assurance that any of these increases in scale, expansion of personnel, equipment, or
process enhancements will be successfully implemented, or that we will have adequate space in our facilities to accommodate such required
expansion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws
and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished
profits and future earnings.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
our products and any product candidates that obtain regulatory approval and are marketed in the United States, if any, our arrangements
with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that
may constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for
which we obtain marketing approval. In addition, we may be subject to health information privacy and security regulation by United
States. federal and state governments and foreign jurisdictions in which we conduct our business. The laws that may affect our ability
to operate include:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering
    or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase
    or recommendation of an item or service for which payment may be made under a federal healthcare program, such as the Medicare and
    Medicaid programs; a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order
    to have committed a violation;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal
    civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal
    and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government,
    including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid,
    decrease or conceal an obligation to pay money to the federal government; actions may be brought by the government or a whistleblower
    and may include an assertion that a claim for payment by federal health care programs for items and services which results from a
    violation of the federal Anti-Kickback Statue constitutes a false or fraudulent claim for purposes of the False Claims Act;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal Health Insurance Portability and Accountability
    Act of 1996 (&#8220;HIPAA&#8221;) that imposes criminal and civil liability for executing a scheme to defraud any health care
    benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false
    statement in connection with the delivery of or payment for health care benefits, items or services; similar to the United States
    federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to
    violate it in order to have committed a violation; HIPAA, as amended by the Health Information Technology and Clinical Health Act
    of 2009 (&#8220;HITECH&#8221;) and their respective implementing regulations, which imposes certain obligations, including
    mandatory contractual terms, on covered healthcare providers, health plans and healthcare clearinghouses, as well as their business
    associates, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    Physician Payments Sunshine Act, enacted as part of the PPACA, which requires certain manufacturers of drugs, devices, biologics
    and medical supplies that are reimbursable under Medicare, Medicaid or the Children&#8217;s Health Insurance Program to report annually
    to CMS information related to payments and other transfers of value to physicians
    and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">analogous
    state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing
    arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private
    insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which
    differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Efforts
to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial
costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to
be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil,
criminal and administrative penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government
funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians
or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they
may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government funded healthcare
programs.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Product
liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
face an inherent risk of product liability claims as a result of the clinical testing of our product candidates despite obtaining appropriate
informed consents from our clinical trial participants. We will face an even greater risk if we obtain marketing approval for and commercially
sell CTx-1301, CTx-1302 and/or CTx-2103, or any other product candidate. For example, we may be sued if any product that we develop allegedly
causes injury or is found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability
claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product,
negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot
successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization
of our product candidates. Regardless of the merits or eventual outcome, liability claims may result in:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">decreased
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">injury
    to our reputation and significant negative media attention;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">withdrawal
    of clinical trial participants;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">initiation
    of investigations by regulators;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">product
    recalls, withdrawals or labeling, marketing or promotional restrictions;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">significant
    costs to defend resulting litigation;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">substantial
    monetary awards to trial participants or patients;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">loss
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
    inability to commercialize any products that we may develop.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
any of our product candidates are approved for commercial sale, we will be highly dependent upon consumer perceptions of us and the safety
and quality of our products. We could be adversely affected if we are subject to negative publicity. We could also be adversely affected
if any of our products or any similar products manufactured and distributed by other companies prove to be, or are asserted to be, harmful
to patients. Because of our dependence upon consumer perceptions, any adverse publicity associated with illness or other adverse effects
resulting from patients&#8217; use or misuse of our products or any similar products distributed by other companies could have a material
adverse impact on our financial condition or results of operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
product liability insurance coverage may not be adequate to cover any and all liabilities that we may incur.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
currently have $10.0 million in product liability insurance coverage in the aggregate, which may not be adequate to cover any and all
liabilities that we may incur. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable
cost or in an amount adequate to satisfy any liability that may arise. Large judgments have been awarded in class action lawsuits based
on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly
if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business. In addition, we may not be able
to obtain or maintain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability
claims, which could prevent or inhibit the commercial production and sale of our products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur
costs that could have a material adverse effect on the success of our business.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are subject to numerous environmental, health and safety laws and regulations. Our operations may involve the use of hazardous and flammable
materials, including chemicals and biological materials. Our operations produce hazardous waste products. We expect to contract with
third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials.
In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages,
and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
we maintain workers&#8217; compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting
from the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential
liabilities. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws
and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to
comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Managing Our Growth, Our Employees, and Our Operations</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing
our growth strategy and managing any growth.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
management, personnel, systems, and facilities currently in place are not adequate to support our business plan and near-term future
growth. We will need to further expand our manufacturing team, clinical team, managerial, operational, financial, and other resources
to support our planned research, development and commercialization activities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
manage our operations, growth and various projects effectively requires that we:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">continue
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">attract
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">manage
    our commercialization activities for our product candidates effectively and in a cost-effective manner;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">manage
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">manage
    our third-party supply and manufacturing operations effectively and in a cost-effective manner, while increasing production capabilities
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">manage
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, historically, we have utilized and continue to utilize the services of part-time outside consultants to perform a number of
tasks for us, including tasks related to product development and clinical testing. Our growth strategy may also entail expanding our
use of consultants to implement these and other tasks going forward. We rely on consultants for certain functions of our business and
will need to effectively manage these consultants to ensure that they successfully carry out their contractual obligations and meet expected
deadlines. There can be no assurance that we will be able to manage our existing consultants or find other competent outside consultants,
as needed, on economically reasonable terms, or at all. If we are not able to effectively manage our growth and expand our organization
by hiring new employees and expanding our use of consultants, we might be unable to implement successfully the tasks necessary to execute
effectively on our planned research, development and commercialization activities and, accordingly, might not achieve our research, development
and commercialization goals.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and/or sell
our product candidates, we may be unable to generate any revenue.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not currently have an organization for the sale, marketing or distribution of CTx-1301, CTx-1302, or CTx-2103. As a result, we must
build this organization, or enter into a marketing collaboration with a third party, in order to commercialize CTx-1301, CTx-1302, and/
or CTx-2103. The establishment and development of our own sales force in the United States to market CTx-1301, CTx-1302, and/or CTx-2103
will be expensive and time consuming and could delay any product launch. We cannot be certain that we would be able to successfully develop
this capacity, and even if we do, the cost of establishing and maintaining such an organization may exceed the benefit of doing so.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
are significant risks involved in building and managing a sales organization, including our ability to hire, retain and incentivize qualified
individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, effectively manage a geographically
dispersed sales and marketing team and successfully negotiate with managed care and third-party payors. Any failure or delay in the development
of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Pursuant to the Commercialization
Agreement, Indegene will provide us with commercialization services for CTx-1301, including services related to (a) medical affairs &amp;
pharmacovigilance; (b) pricing, reimbursement and market access; (c) commercial operations; and (d) marketing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
also may enter into additional strategic partnerships with third parties to commercialize our product candidates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the Commercialization Agreement, we and Indegene will enter into statements of work that will set forth, among other things, the services
to be performed by Indegene, the deliverables for such services and the fees to be paid by us. We may be unable to negotiate the terms
of the statements of work, including the services to be performed by Indegene or the fees payable by us, on terms acceptable to us, or
at all. If we are unable to do so, we will have to seek other collaborations for the commercialization of CTx-1301, which may delay commercialization.
We may also have difficulty establishing relationships with third parties on terms that are acceptable to us, or in all of the regions
where we wish to commercialize our products, or at all. If we are unable to establish adequate sales, marketing and distribution capabilities,
whether independently or with third parties, we may not be able to generate sufficient product revenue and may not become profitable.
We will be competing with many companies that currently have extensive and well-funded marketing and sales operations and/or ingrained
distribution channels. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable
to compete successfully against these more established companies.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize
our product candidates or otherwise implement our business plan.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Our ability to compete in the
highly competitive pharmaceuticals industry depends upon our ability to attract and retain highly qualified managerial, scientific, medical,
sales and marketing and other personnel. We are highly dependent on our management and scientific personnel. The loss of the services
of any of these individuals could impede, delay or prevent the successful development of our product pipeline, completion of our planned
clinical trials, commercialization of our product candidates or in-licensing or acquisition of new assets and could negatively impact
our ability to successfully implement our business plan. If we lose the services of any of these individuals, we might not be able to
find suitable replacements on a timely basis or at all, and our business could be harmed as a result. In December 2023, two executive
officers, including our Chief Financial Officer, and two clinical operations employees resigned. On January 25, 2024, we appointed
Ms. Callahan as our Senior Vice President and Chief Financial Officer.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In December 2023, our
four independent members of our Board resigned. The two current members of our Board are not independent, and we do not currently
have an Audit Committee, a Compensation Committee or a Nominating and Corporate Governance Committee. Because our Board is currently
comprised solely of non-independent directors, one of whom is our Chief Executive Officer, we do not receive the benefit of
independent oversight over actions being taken. Additionally, the lack of a majority independent board members may make it difficult
for us to maintain and develop internal controls, to cure any material weaknesses in internal controls and to raise money in the
financial markets. On December 26, 2023, we received a letter from the Staff indicating that, based upon the resignation of three
members of our Board on December 12, 2023 and December 13, 2023, we no longer comply with the independent director, audit committee,
compensation committee and independent director oversight of director nominations requirements as set forth in Nasdaq Listing Rule
5605 (the &#8220;Independent Director Rule&#8221;). We are in the process of identifying new directors but there is no assurance that we will be able to attract new directors, maintain
a majority independent board or regain compliance with the Independent Director Rule.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We maintain &#8220;key man&#8221;
insurance policies on the lives of specific individuals but not on the lives of all critical employees. In order to retain valuable employees
at our company, in addition to salary and cash incentives, we may provide stock options that vest over time. The value to employees of
stock options that vest over time will be significantly affected by movements in our stock price that are beyond our control and may at
any time be insufficient to counteract offers from other companies.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for
qualified personnel among biotechnology, pharmaceutical and other businesses. We could have difficulty attracting experienced personnel
to our company and may be required to expend significant financial resources in our employee recruitment and retention efforts. Many
of the other pharmaceutical companies with whom we compete for qualified personnel have greater financial and other resources, different
risk profiles and longer histories in the industry than we do. They also may provide more diverse opportunities and better chances for
career advancement. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience
constraints that will harm our ability to implement our business strategy and achieve our business objectives.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, we have scientific and clinical advisors who assist us in formulating our development and clinical strategies. These advisors
are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability
to us. In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies
that may compete with ours.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
research and development is focused on discovering and developing product candidates but these product candidates may not make it to
the market.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
development research and clinical development efforts to date have resulted in product candidates, CTx-1301, CTx-1302, for the treatment
of ADHD, and CTx-2103, for the treatment of anxiety. As part of our growth strategy, we intend to identify, develop and market additional
product candidates. We are exploring various therapeutic opportunities for our pipeline and proprietary technologies. We may spend several
years completing our development of any particular current or future internal product candidates, and failure can occur at any stage.
We may not be able to develop drugs that are bioequivalent, safe and effective and/or that have commercially significant improvements
over already approved drugs. The product candidates to which we allocate our resources may not end up being successful. The success of
this strategy depends partly upon our ability to identify, select, discover and acquire promising product candidates and products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
process of proposing, negotiating and implementing a license or acquisition of a product candidate or approved product is lengthy and
complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for
the license or acquisition of product candidates and approved products. We have limited resources to identify and execute the acquisition
or in-licensing of third-party products, businesses and technologies and integrate them into our current infrastructure. Moreover, we
may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the
anticipated benefits of such efforts. We may not be able to acquire the rights to additional product candidates on terms that we find
acceptable, or at all.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, future acquisitions may entail numerous operational and financial risks, including:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">higher
    than expected acquisition and integration costs; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulty
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Further,
any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical
testing and approval by the FDA and other regulatory authorities.</FONT></P>

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we do not successfully develop and commercialize product candidates based upon our Precision Timed Release platform technology, we will
not be able to obtain product revenue in future periods, which likely would result in significant harm to our financial position and
adversely affect our stock price.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating
results to fall below expectations.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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operations to date have been primarily limited to formulating and developing our product candidates and undertaking clinical trials of
our product candidates. We have not yet obtained regulatory approvals for any of our product candidates. Consequently, any predictions
about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products
on the market. Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control
and may be difficult to predict, including the following:</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">potential
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">market
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability and third parties&#8217; abilities to protect intellectual property rights;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to adequately support future growth;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">potential
    liabilities associated with hazardous materials;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">future
    accounting pronouncements or changes in our accounting policies.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
operating results and liquidity needs could be negatively affected by market fluctuations and economic downturn.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
operating results and liquidity could be negatively affected by economic conditions generally, both in the United States and elsewhere
around the world. The market for discretionary medical products and procedures may be particularly vulnerable to unfavorable economic
conditions. Some patients may consider certain of our product candidates to be discretionary, and if full reimbursement for such products
is not available, demand for these products may be tied to the discretionary spending levels of our targeted patient populations. Domestic
and international equity and debt markets have experienced and may continue to experience heightened volatility and turmoil based on
domestic and international economic conditions and concerns. In the event these economic conditions and concerns continue or worsen,
and the markets continue to remain volatile, our operating results and liquidity could be adversely affected by those factors in many
ways, including weakening demand for certain of our products and making it more difficult for us to raise funds if necessary, and our
stock price may decline. Additionally, although we plan to market our products primarily in the United States, our partners have extensive
global operations, indirectly exposing us to risk.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
business and operations would suffer in the event of failures in our internal computer systems.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Despite
the implementation of security measures, our internal computer systems and those of our current and any future partners, contractors
and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication
and electrical failures. While we have not experienced any such material system failure, accident or security breach to date, if such
an event were to occur and cause interruptions in our operations, it could result in a material disruption of our manufacturing activities,
development programs and our business operations. For example, the loss of manufacturing records or clinical trial data from completed
or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or
reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications,
or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further commercialization and
development of our products and product candidates could be delayed.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity
and data leakage risks.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Significant
disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary
course of business, we collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure
manner to maintain the confidentiality and integrity of such confidential information. The size and complexity of our information technology
systems, and those of our third-party vendors with whom we contract, make such systems potentially vulnerable to service interruptions
and security breaches from inadvertent or intentional actions by our employees, partners or vendors, from attacks by malicious third
parties, or from intentional or accidental physical damage to our systems infrastructure maintained by us or by third parties. Maintaining
the secrecy of this confidential, proprietary, or trade secret information is important to our competitive business position. While we
have taken steps to protect such information and invested in information technology, there can be no assurance that our efforts will
prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential
information that could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive
information. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation
or misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, fraud,
trickery or other forms of deception, or for any other reason, could enable others to produce competing products, use our proprietary
technology or information, or adversely affect our business or financial condition. Further, any such interruption, security breach,
loss or disclosure of confidential information, could result in financial, legal, business, and reputational harm to us and could have
a material adverse effect on our business, financial position, results of operations or cash flow.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to Our Intellectual Property</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
our intellectual property related to our products or product candidates is not adequate, we may not be able to compete effectively in
our market.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related
to our products, product candidates and technology. Any disclosure to or misappropriation by third parties of our confidential or proprietary
information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in
our market.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Due
to legal standards relating to patentability, validity, enforceability and scope of claim, patents covering pharmaceutical and biotechnology
inventions involve complex legal, scientific and factual questions. Formulation of drug products such as ours with complex release profiles
is an area of intense research, publishing and patenting, which limits the scope of any new patent applications. As a result, our ability
to obtain, maintain and enforce patents is uncertain and any rights under any existing patents, or any patents we might obtain or license,
may not provide us with sufficient protection for our products and product candidates to afford a commercial advantage against competitive
products or processes. The patent applications that we own may fail to result in issued patents in the United States or in foreign countries.
Even if patents do successfully issue, third parties may challenge their patentability, validity (e.g., by discovering previously unidentified
prior art, or a patent-barring event such as a prior public disclosure, use, sale or offer for sale of the invention), enforceability
or scope, which may result in such patents being narrowed, invalidated or held unenforceable. For example, United States patents
may be challenged by third parties via <I>inter partes </I>review, post grant review, derivation or interference proceedings at the USPTO,
and European patents may be challenged via an opposition proceeding at the European Patent Office. Furthermore, if we were to assert
our patent rights against a competitor, the competitor could challenge the validity and/or enforceability of the asserted patent rights.
Although a granted United States patent is entitled to a statutory presumption of validity, its issuance is not conclusive
as to its validity or its enforceability, and it may not provide us with adequate proprietary protection or competitive advantages against
competitors with similar products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
the breadth or strength of protection provided by the patents and patent applications we hold or pursue with respect to our products
and product candidates is successfully challenged, we may face unexpected competition that could have a material adverse impact on our
business. Even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or
prevent others from designing around our claims. For example, a third party may develop a competitive product that provides therapeutic
benefits similar to our products or product candidates but is sufficiently different to fall outside the scope of our patent protection.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
if we encounter delays in our clinical trials or entry onto the market in a particular jurisdiction, the period of time during which
we could market a particular product under patent protection would be reduced.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
where laws provide protection, costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary
rights, and the outcome of such litigation would be uncertain. If we or one of our future collaborators were to initiate legal proceedings
against a third party to enforce a patent covering a product or our technology, the defendant could counterclaim that our patent is invalid
and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability
are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including
lack of novelty, obviousness, lack of written description, non-enablement or a patent-barring event, such as a public disclosure, use
or sale of the invention more than a year before the filing date of the application. Grounds for an unenforceability assertion could,
for example, be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO, or
made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
With respect to validity, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner
were unaware during prosecution, or that a third party challenging one of our patents would not assert that a patent-barring event had
occurred. If a plaintiff or a defendant were to prevail on a legal assertion of invalidity and/or unenforceability against one or more
of our patents, we would lose at least part, and perhaps all, of the patent protection for one or more of our products or product candidates.
Such a loss of patent protection could have a material adverse impact on our business.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
we may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in reexamination, <I>inter partes
</I>review, or interference proceedings challenging our patent rights. Patents based on applications that we file in the future may also
be subject to derivation and/or post-grant review proceedings. An adverse determination in any such submission, proceeding or litigation
could reduce the scope of, or invalidate, our patent rights and allow third parties to commercialize our technology or products and compete
directly with us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened,
it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately
enforce our intellectual property rights even in the jurisdictions where we seek protection.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Filing,
prosecuting and defending patents on product candidates in all countries and jurisdictions throughout the world would be prohibitively
expensive, and our intellectual property rights in some countries outside the United States are less extensive than in the United States.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws
in the United States. Consequently, even where we do elect to pursue patent rights outside the United States, we may not be able to obtain
relevant claims and/or we may not be able to prevent third parties from practicing our inventions in all countries outside the United
States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Competitors
may use our technologies in jurisdictions where we do not pursue and obtain patent protection to develop their own products and further,
may possibly export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as
that in the United States. These products may compete with our products and our patents or other intellectual property rights may not
be effective or sufficient to prevent them from competing. Even if we pursue and obtain issued patents in particular jurisdictions, our
patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from competing with us.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.
The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual
property protection. This could make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation
of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner
must grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including
government agencies or government contractors. In these countries, patents may provide limited or no benefit.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patent
protection must ultimately be sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes.
Accordingly, we have, and may in the future, choose not to seek patent protection in certain countries. Furthermore, while we intend
to protect our intellectual property rights in certain markets for our products, we cannot ensure that we will be able to initiate or
maintain similar efforts in all jurisdictions in which we may wish to market our products. Accordingly, our efforts to protect our intellectual
property rights in such countries may be inadequate.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Obtaining
and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements
imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other
provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might
be able to enter the market earlier than would otherwise have been the case.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome
in that litigation would have a material adverse effect on our business.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell their approved
products and our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties.
Numerous United States and foreign issued patents and pending patent applications, which are owned by third parties, exist in
the fields in which we are developing product candidates. As the pharmaceutical industry expands and more patents are issued, the risk
increases that our products and product candidates may give rise to claims of infringement of the patent rights of others. There may,
for example, be issued patents of third parties of which we are currently unaware, that may be infringed by our products or product candidates,
which could prevent us from being able to commercialize our products or product candidates, respectively. Because patent applications
can take many years to issue, there may be currently pending applications which may later result in issued patents that our products
or product candidates may infringe.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
pharmaceutical industry is rife with patent litigation between patent holders and producers of follow-on drug products. The possibility
of blocking FDA approval of a competitor&#8217;s product for up to 30 months provides added incentive to litigate over Orange Book patents,
but suits involving non-Orange Book patents are also common in the ADHD space. There have been multiple patent litigations involving
nearly all of the medications for treatment of ADHD. This trend may continue and, as a result, we may become party to legal matters and
claims arising in the ordinary course of business.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
may be exposed to, or threatened with, future litigation by third parties alleging that our products or product candidates infringe their
intellectual property rights. If one of our products or product candidates is found to infringe the intellectual property rights of a
third party, we or our collaborators could be enjoined by a court and required to pay damages and could be unable to commercialize the
applicable approved products and product candidates unless we obtain a license to the patent. A license may not be available to us on
acceptable terms, if at all. In addition, during litigation, the patent holder could obtain a preliminary injunction or other equitable
relief which could prohibit us from making, using or selling our approved products, pending a trial on the merits, which may not occur
for several years.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is a substantial amount of litigation involving patent and other intellectual property rights in the pharmaceutical industry generally.
If a third-party claims that we or our collaborators infringe its intellectual property rights, we may face a number of issues, including,
but not limited to:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">infringement
    and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert
    our management&#8217;s attention from our core business;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">third
    parties bringing claims against us may have more resources than us to litigate claims against us;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">substantial
    damages for infringement, which we may have to pay if a court decides that the product at issue infringes on or violates the third
    party&#8217;s rights, and, if the court finds that the infringement was willful, we could be ordered to pay treble damages and the
    patent owner&#8217;s attorneys&#8217; fees;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a
    court prohibiting us from selling our product or any product candidate approved in the future, if any, unless the third party licenses
    its rights to us, which it is not required to do;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">if
    a license is available from a third party, we may have to pay substantial royalties, fees or grant cross-licenses to our intellectual
    property rights; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">redesigning
    any of our products and product candidates so they do not infringe, which may not be possible or may require substantial monetary
    expenditures and time.</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
drug development strategy relies heavily upon the 505(b)(2) regulatory approval pathway, which requires us to certify that we do not
infringe upon third-party patents covering approved drugs. Such certifications routinely result in third-party claims of intellectual
property infringement, the defense of which would be costly and time consuming, and an unfavorable outcome in any litigation may prevent
or delay our development and commercialization efforts which would harm our business.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
commercial success depends in large part on our avoiding infringement of the patents and proprietary rights of third parties for existing
approved drug products. Because we utilize the 505(b)(2) regulatory approval pathway for the approval of our products and product candidates,
we rely in whole or in part on studies conducted by third parties related to those approved drug products. As a result, upon filing with
the FDA for approval of our product candidates, we will be required to certify to the FDA that either: (1) there is no patent information
listed in the FDA&#8217;s Orange Book with respect to our NDA; (2) the patents listed in the Orange Book have expired; (3) the listed
patents have not expired, but will expire on a particular date and approval is sought after patent expiration; or (4) the listed patents
are invalid or will not be infringed by the manufacture, use or sale of our proposed drug product. If we certify to the FDA that a patent
is invalid or not infringed, or a Paragraph IV certification, a notice of the Paragraph IV certification must also be sent to the patent
owner once our 505(b)(2) NDA is accepted for filing by the FDA. The third party may then initiate a lawsuit against us asserting infringement
of the patents identified in the notice. The filing of a patent infringement lawsuit within 45 days of receipt of the notice automatically
prevents the FDA from approving our NDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled,
or the court reaches a decision in the infringement lawsuit in our favor. If the third party does not file a patent infringement lawsuit
within the required 45-day period, our NDA will not be subject to the 30-month stay. However, even if the third party does not sue within
the 45-day time limit, thereby invoking the 30-month stay, it may still challenge our right to market our product upon FDA approval;
therefore, some risk of an infringement suit remains even after the expiry of the 45-day limit.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may be unable to adequately prevent disclosure of trade secrets and other proprietary information.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent protection
is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our
employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other
proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate
remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade
secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our
proprietary rights. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information
to develop products that compete with our products or cause additional, material adverse effects upon our competitive business position.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming
ownership of what we regard as our own intellectual property.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Some
of our employees were previously employed at other companies, including actual or potential competitors. We may also engage advisors
and consultants who are concurrently employed at other organizations or who perform services for other entities. Although we try to ensure
that our employees, advisors and consultants do not use the proprietary information or know-how of others in their work for us, we may
be subject to claims that we or our employees, advisors, or consultants have used or disclosed intellectual property, including trade
secrets or other proprietary information, of any such party&#8217;s former employer or in violation of an agreement with or legal obligation
in favor of another party. Litigation may be necessary to defend against these claims.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, while we generally require our employees, consultants, advisors and contractors who may be involved in the development of intellectual
property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with
each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing
or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine
the ownership of what we regard as our intellectual property. Similarly, we may be subject to claims that an employee, advisor or consultant
performed work for us that conflicts with that person&#8217;s obligations to a third party, such as an employer or former employer, and
thus, that the third party has an ownership interest in the intellectual property arising out of work performed for us. Litigation may
be necessary to defend against these claims.</FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property
rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial
costs and be a distraction to management.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
decision to seek approval of CTx-1301, CTx-1302, and/or CTx-2103 and other product candidates under 505(b)(2) may increase the risk that
patent infringement suits are filed against us, which would delay the FDA&#8217;s approval of such product candidates.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
connection with any NDA that we file under the 505(b)(2) regulatory pathway, if there are patents that claim the approved drug contained
in our product candidates and referenced in our 505(b)(2) NDA, we must certify to the FDA and notify the patent holder that any patents
listed for the approved drug in the FDA&#8217;s Orange Book publication are invalid, unenforceable or will not be infringed by the manufacture,
use or sale of our drug. If a patent infringement lawsuit is filed against us within 45 days of its receipt of notice of our certification,
the FDA is automatically prevented from approving our 505(b)(2) NDA until the earliest of 30 months, expiration of the patent, settlement
of the lawsuit or a court decision in the infringement case that is favorable to us, or such shorter or longer period as may be ordered
by a court. Such actions are routinely filed by patent owners. Accordingly, we may invest significant time and expense in the development
of our product candidates only to be subject to significant delay and patent litigation before our product candidates may be commercialized.
We may not be successful in defending any patent infringement claim. Even if we are found not to infringe, or a plaintiff&#8217;s patent
claims are found invalid or unenforceable, defending any such infringement claim would be expensive and time-consuming, and would delay
launch of our products or our other product candidates and distract management from their normal responsibilities.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Risks
Related to this Offering, the Securities Markets and Ownership of Our Securities</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
we fail to regain compliance with the continued listing requirements of Nasdaq, our common stock and/or warrants may be delisted and
the price of our common stock and/or warrants and our ability to access the capital markets could be negatively impacted.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
common stock and warrants are currently listed for trading on Nasdaq. On May 16, 2023, we received a notice from the Staff stating that we no longer comply with the minimum stockholders&#8217; equity requirement of $2.5 million under the Nasdaq Stock Market Listing Rule 5550(b)(1) (the &#8220;Minimum
Stockholders&#8217; Equity Rule&#8221;) for continued listing. We submitted a plan of compliance to Nasdaq on June 30, 2023. On July 28, 2023, Nasdaq notified us
that that it granted an extension until November 13, 2023 to regain compliance with the Minimum Stockholders&#8217; Equity Rule, conditioned
upon achievement of certain milestones included in the plan of compliance previously submitted to Nasdaq, including a plan to raise additional
capital. On November 14, 2023, we received a letter from Nasdaq indicating that, based upon the our continued non-compliance
with the Minimum Stockholders&#8217; Equity Rule, the Staff had determined to delist the our securities from Nasdaq, subject to our request for a hearing before the Nasdaq Hearings Panel
(the &#8220;Panel&#8221;).</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
timely requested a hearing before the Panel and Nasdaq granted our request. At the Panel hearing, which is expected to take place in
February 2024, we will submit our plan to regain compliance, as well as our ability to sustain long-term compliance, with all applicable
requirements for continued listing on Nasdaq, including compliance with the Minimum Stockholders&#8217; Equity Rule and the Independent
Director Rule (defined below). The delisting action by the Staff will be stayed pending the hearing and the expiration of any additional
extension period granted by the Panel following the Panel hearing. We intend to continue to take definitive steps in an effort to evidence
compliance with the Minimum Stockholders&#8217; Equity Rule, the Independent Director Rule and other Nasdaq listing requirements; however,
there can be no assurance that the Panel will grant our request for continued listing or that we will be able to evidence compliance
with the Minimum Stockholders&#8217; Equity Rule, the Independent Director Rule and other Nasdaq listing requirements within any extension
period that may be granted by the Panel. To remain listed we will need to evidence the ability to maintain long term compliance
with the Minimum Stockholders&#8217; Equity Rule. There are limited ways we can improve our financial condition prior to our hearing
before the Panel in order to demonstrate compliance with the Minimum Stockholders&#8217; Equity Rule. We may attempt to raise further
capital, on less favorable terms, which may result in further dilution to you and our current shareholders. We may be unsuccessful in
raising further capital, or otherwise satisfying the Minimum Stockholders&#8217; Equity Rule.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
July 28, 2023, we received a notice from Nasdaq indicating that we were not in compliance with the requirement to maintain a minimum
bid price of $1.00 per share for continued listing on Nasdaq. We were provided a compliance period of 180 calendar days from the date
of the notice, or until January 24, 2024, to regain compliance with the minimum closing bid requirement, pursuant to Nasdaq Listing Rule
5810(c)(3)(A). On November 30, 2023, we effected a reverse stock split of our common stock, and on December 15, 2023, we received notice
from Nasdaq that we have regained compliance with minimum closing bid price requirement. There can be no assurance that we will continue
to maintain compliance with the minimum closing bid price requirement or the other Nasdaq listing requirements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
December 26, 2023, we received a letter from the Staff indicating that, based upon the resignation of three members of our Board on
December 12, 2023 and December 13, 2023, we no longer comply with the independent director, audit committee, compensation committee
and independent director oversight of director nominations requirements as set forth in Nasdaq Listing Rule 5605 (the
&#8220;Independent Director Rule&#8221;). Our Board currently consists of two directors, neither of
whom are independent.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are in the process of identifying potential new directors and intend to show progress in complying with the Independent Director Rule
prior to the Panel hearing. There can be no assurance that we will regain compliance with the Independent Director Rule.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
must satisfy Nasdaq&#8217;s continued listing requirements, including, among other things, the Minimum Stockholders&#8217; Equity Rule
and the Independent Director Rule or risk delisting, which could have a material adverse effect on our business. If our common stock
and warrants are delisted from Nasdaq, it could materially reduce the liquidity of our common stock and warrants and result in a corresponding
material reduction in the price of our common stock and warrants as a result of the loss of market efficiencies associated with Nasdaq
and the loss of federal preemption of state securities laws. In addition, delisting could harm our ability to raise capital through alternative
financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers
and employees and fewer business development opportunities. If our common stock and warrants are delisted, it could be more difficult
to buy or sell our common stock and warrants or to obtain accurate quotations, and the price of our common stock and warrants could suffer
a material decline. Delisting could also impair our ability to raise capital on acceptable terms, if at all.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>This
offering is being made on a best efforts basis and we may sell fewer than all of the securities offered hereby and may receive significantly
less in net proceeds from this offering, which will provide us only limited working capital</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
offering is being made on a best efforts basis and we may sell fewer than all of the securities offered hereby and may receive significantly
less in net proceeds from this offering. We believe that the net proceeds from this offering, together with our cash on hand,
will satisfy our capital needs through late second quarter of 2024 under our current business plan. Following this offering,
we will need to raise additional capital to fund our operations and continue to support our planned development and commercialization
activities.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Because
management has broad discretion as to the use of the net proceeds from this offering, you may not agree with how we use them, and such
proceeds may not be applied successfully.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
management will have considerable discretion over the use of proceeds from this offering. We currently intend to use the net proceeds
from this offering for continued research and development and commercialization activities for CTx-1301, and for working capital, capital
expenditures, and general corporate purposes, including investing further in research and development efforts. However, our management
will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not
necessarily improve our operating results or enhance the value of our securities, or that you otherwise do not agree with. You will be
relying on the judgment of our management concerning these uses and you will not have the opportunity, as part of your investment decision,
to assess whether the proceeds are being used appropriately. The failure of our management to apply these funds effectively could, among
other things, result in unfavorable returns and uncertainty about our prospects, each of which could cause the price of our securities
to decline.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
you purchase securities in this offering, you will suffer immediate dilution of your investment.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">You
will incur immediate and substantial dilution as a result of this offering. The public offering price per share of common stock and accompanying
warrants and the public offering price per pre-funded warrant and accompanying warrants will be substantially higher than the as adjusted
net tangible book value per share of our common stock after giving effect to this offering. Therefore, if you purchase securities in
this offering, you will pay a price per share of common stock you acquire that substantially exceeds our pro forma net tangible book
value per share after this offering. Based on the public offering price of $2.00 per share of common stock and accompanying
warrants and our pro forma net tangible book value as of September 30, 2023, you will experience immediate dilution of
$0.15 per share, representing the difference between our pro forma as adjusted net tangible book value per share after giving
effect to this offering and the public offering price.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>There
is no public market for the pre-funded warrants or warrants offered by us.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is no established public trading market for the pre-funded warrants or warrants, and we do not expect such a market to develop. In addition,
we do not intend to apply to list the pre-funded warrants or warrants on any national securities exchange or other nationally recognized
trading system. Without an active trading market, the liquidity of the pre-funded warrants and warrants will be limited.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Holders
of pre-funded warrants and warrants purchased in this offering will have no rights as common stockholders until such holders exercise
their pre-funded warrants or warrants and acquire our common stock.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Until
holders of the pre-funded warrants and warrants acquire shares of our common stock upon exercise thereof, such holders will have no rights
with respect to the shares of our common stock underlying the pre-funded warrants and warrants. Upon exercise of the pre-funded warrants
and warrants, the holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date
occurs after the exercise date.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>The
warrants are speculative in nature.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends,
but rather merely represent the right to acquire shares of common stock at a fixed price for a limited period of time. Moreover, following
this offering, the market value of the warrants, if any, will be uncertain and there can be no assurance that the market value of the
warrants will equal or exceed their imputed offering price. The warrants will not be listed or quoted for trading on any market or exchange.
There can be no assurance that the market price of our common stock will ever equal or exceed the exercise price of the warrants, and
consequently, the warrants may expire valueless.</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Purchasers
who purchase our securities in this offering pursuant to a securities purchase agreement may have rights not available to purchasers
that purchase without the benefit of a securities purchase agreement.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to rights and remedies available to all purchasers in this offering under federal securities and state law, the purchasers that
enter into a securities purchase agreement will also be able to bring claims of breach of contract against us. The ability to pursue
a claim for breach of contract provides those investors with the means to enforce the covenants uniquely available to them under the
securities purchase agreement including: (i) timely delivery of shares; (ii) agreement to not enter into variable rate financings for
one year from closing, subject to certain exceptions; (iii) agreement to not enter into any financings for 90 days from closing;
and (iv) indemnification for breach of contract.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>This
is a best efforts offering, with no minimum amount of securities is required to be sold, and we may not raise the amount of capital we
believe is required for our business plans, including our near-term business plans.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
placement agent has agreed to use its reasonable best efforts to solicit offers to purchase the securities in this offering. The placement
agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar
amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering.
Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement
agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above.
We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and
investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our
continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is required
for our operations in the short-term and may need to raise additional funds, which may not be available or available on terms acceptable
to us.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Because
there is no minimum required for the offering to close, investors in this offering will not receive a refund in the event that we do
not sell an amount of securities sufficient to pursue the business goals outlined in this prospectus.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have not specified a minimum offering amount nor have or will we establish an escrow account in connection with this offering. Because
there is no escrow account and no minimum offering amount, investors could be in a position where they have invested in our company,
but we are unable to fulfill our objectives due to a lack of interest in this offering. Further, because there is no escrow account in
operation and no minimum investment amount, any proceeds from the sale of securities offered by us will be available for our immediate
use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. Investor funds
will not be returned under any circumstances whether during or after the offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>&#160;</I></B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I></I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>An
active trading market for our common stock or warrants may not be sustained.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">An
active trading market for our common stock or warrants may not be sustained. The lack of an active market for our common stock or warrants
may impair investors&#8217; ability to sell their common stock or warrants at the time they wish to sell them or at a price that they
consider reasonable, may reduce the fair market value of their shares of common stock or warrants and may impair our ability to raise
capital to continue to fund operations by selling securities and may impair our ability to acquire additional intellectual property assets
by using our securities as consideration.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>The
prices of our securities may be volatile, which could subject us to securities class action litigation and our stockholders could incur
substantial losses.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 277.15pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
market price for our common stock and warrants may be volatile and subject to wide fluctuations in response to factors including the
following:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">issuance
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">general
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
particular, the market prices of clinical-stage companies like ours have been highly volatile due to factors, including, but not limited
to:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">failure
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">proposals
    for legislation that would place restrictions on the price of medical therapies.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
and other market and industry factors may cause the market price and demand for our common stock and warrants to fluctuate substantially,
regardless of our actual operating performance, which may limit or prevent investors from readily selling their shares of common stock
or warrants and may otherwise negatively affect the liquidity of our common stock and warrants. In addition, the stock market in general,
and Nasdaq and emerging growth companies in particular, have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of these companies. In the past, when the market price of a security
has been volatile, holders of that security have instituted securities class action litigation against the company that issued the security.
If any of our stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could
also divert the time and attention of our management.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
are an &#8220;emerging growth company,&#8221; and will be able take advantage of reduced disclosure requirements applicable to &#8220;emerging
growth companies,&#8221; which could make our securities less attractive to investors.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are an &#8220;emerging growth company,&#8221; as defined in the JOBS Act and, for as long as we continue to be an &#8220;emerging growth
company,&#8221; we intend to take advantage of certain exemptions from various reporting requirements applicable to other public companies
but not to &#8220;emerging growth companies,&#8221; including, but not limited to, not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and
stockholder approval of any golden parachute payments not previously approved. We could be an &#8220;emerging growth company&#8221; for
up to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1.235
billion, (ii) the date that we become a &#8220;large accelerated filer&#8221; as defined in Rule 12b-2 under the Exchange Act, or (iii)
the date on which we have issued more than $1 billion in non-convertible debt during the preceding three year period.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
intend to take advantage of these reporting exemptions described above until we are no longer an &#8220;emerging growth company.&#8221;
Under the JOBS Act, &#8220;emerging growth companies&#8221; can also delay adopting new or revised accounting standards until such time
as those standards apply to private companies. We have irrevocably elected to avail ourselves of this exemption from new or revised accounting
standards and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not
&#8220;emerging growth companies.&#8221;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot predict if investors will find our securities less attractive if we choose to rely on these exemptions. If some investors find
our securities less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for
our securities and the price of our common stock and warrants may be more volatile.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>As
a public company, we are obligated to develop and maintain proper and effective controls over financial reporting. If we fail to maintain
proper and effective internal controls over financial reporting in the future, our ability to produce accurate and timely financial statements
could be impaired, which could harm our operating results, investors&#8217; views of us and, as a result, the value of our securities.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section
404 of the Sarbanes-Oxley Act requires that we evaluate and determine the effectiveness of our internal controls over financial
reporting and provide a management report on internal control over financial reporting. When we lose our status as an &#8220;emerging
growth company,&#8221; as defined in the JOBS Act, and reach an accelerated filer threshold, our independent registered public accounting
firm will be required to attest to the effectiveness of our internal control over financial reporting. However, for so long as we remain
an emerging growth company, we intend to take advantage of an exemption available to emerging growth companies from these auditor attestation
requirements. The rules governing the standards that must be met for management to assess our internal control over financial reporting
are complex and require significant documentation, testing, and possible remediation. To comply with the requirements of being a reporting
company under the Exchange Act, we will need to upgrade our systems including information technology; implement additional financial
and management controls, reporting systems, and procedures; and hire additional accounting and finance staff. If we or, if required,
our auditors are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in
our financial reporting, and the trading price of our common stock or warrants may decline.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting
in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report
our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting
is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency
in our internal control over financial reporting once that firm begins its Section 404 reviews, we could lose investor confidence in
the accuracy and completeness of our financial reports, the market price of our common stock or warrants could decline, and we could
be subject to sanctions or investigations by Nasdaq, the SEC, or other regulatory authorities. Failure to remedy any material weakness
or significant deficiencies in our internal control over financial reporting, or to implement or maintain other effective control systems
required of public companies, could also restrict our future access to the capital markets.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
will incur significantly increased costs as a result of and devote substantial management time to operating as a public company.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
public company, we will incur significant legal, accounting and other expenses. For example, we will be subject to the reporting
requirements of the Securities Exchange Act of 1934, as amended, and will be required to comply with the applicable requirements of the
Sarbanes-Oxley Act and the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules and regulations subsequently implemented
by the SEC, including the establishment and maintenance of effective disclosure and financial controls, changes in corporate governance
practices and required filing of annual, quarterly and current reports with respect to our business and operating results. These requirements
will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. In addition, our
management and other personnel will need to divert attention from operational and other business matters to devote substantial time to
these public company requirements. We will also need to hire additional accounting and financial staff with appropriate public company
experience and technical accounting knowledge and may need to establish an internal audit function. We also expect that operating as
a public company will make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept
reduced coverage or incur substantially higher costs to obtain coverage. This could also make it more difficult for us to attract and
retain qualified people to serve on our Board, our board committees or as executive officers. In addition, after we no longer
qualify as an &#8220;emerging growth company,&#8221; as defined under the JOBS ACT we expect to incur additional management time and
cost to comply with the more stringent reporting requirements applicable to companies that are deemed accelerated filers or large accelerated
filers, including complying with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We are just beginning
the process of compiling the system and processing documentation needed to comply with such requirements. We may not be able to complete
our evaluation, testing and any required remediation in a timely fashion. In that regard, we currently do not have an internal audit
function, and we will need to hire or contract for additional accounting and financial staff with appropriate public company experience
and technical accounting knowledge.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
cannot predict or estimate the amount of additional costs we may incur as a result of becoming a public company or the timing of such
costs.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price
and trading volume could decline.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
trading market for our common stock and warrants will depend in part on the research and reports that securities or industry analysts
publish about us or our business. We currently have limited research coverage by securities and industry analysts. If we fail to maintain
adequate coverage by securities or industry analysts, the trading price for our stock could be negatively impacted. If one or more of
the analysts who covers us downgrades our stock or publishes inaccurate or unfavorable research about our business, our stock price would
likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock
could decrease, which could cause our stock price and trading volume to decline.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Future
sales of our common stock, warrants, or securities convertible into our common stock may depress our stock price.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
price of our common stock or warrants could decline as a result of sales of a large number of shares of our common stock or warrants
or the perception that these sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult
for us to sell equity securities in the future at a time and at a price that we deem appropriate.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, in the future, we may issue additional shares of common stock, warrants or other equity or debt securities convertible into
common stock in connection with a financing, acquisition, litigation settlement, employee arrangements or otherwise. Any such issuances
could result in substantial dilution to our existing stockholders and could cause the price of our common stock or warrants to decline.
WFIA holds pre-funded warrants to purchase 1,028,955 shares of our common stock. Upon any exercise of such pre-funded warrants, your
ownership interest in our company will be diluted.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Anti-takeover
provisions contained in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a takeover attempt.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
amended and restated certificate of incorporation, bylaws and Delaware law contain provisions which could have the effect of rendering
more difficult, delaying or preventing an acquisition deemed undesirable by our Board. Our corporate governance documents include
provisions:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">controlling
    the procedures for the conduct and scheduling of Board and stockholder meetings; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">providing
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provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation
law, which prevents some stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations
without approval of the holders of substantially all of our outstanding common stock.</FONT></P>

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provision of our amended and restated certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring
a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock or warrants
and could also affect the price that some investors are willing to pay for our common stock and warrants.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We
do not anticipate paying any cash dividends on our common stock in the foreseeable future.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend to retain any future earnings
to finance the operation and expansion of our business, and we do not expect to declare or pay any dividends in the foreseeable future.
Consequently, stockholders must rely on sales of their common stock and warrants after price appreciation, which may never occur, as
the only way to realize any future gains on their investment. There is no guarantee that shares of our common stock or warrants will
appreciate in value or even maintain the price at which stockholders have purchased their shares or warrants.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change of corporate
control.</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of January 25, 2024, our directors, current executive officers and holders of more than 5% of our common stock, together with
their affiliates, beneficially own, in the aggregate, approximately 27% of our outstanding common stock. As a result, these stockholders,
acting together, would have the ability to control the outcome of matters submitted to our stockholders for approval, including the election
of directors and any merger, consolidation or sale of all or substantially all of our assets. In addition, these stockholders, acting
together, would have the ability to control the management and affairs of our company. Accordingly, this concentration of ownership could
harm the market price of our common stock and warrants by:</FONT></P>

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&#8220;Security Ownership of Certain Beneficial Owners and Management&#8221; below for more information regarding the ownership of our
outstanding stock by our executive officers, directors and holders of more than 5% of our common stock, together with their affiliates.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
amended and restated certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive
forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders&#8217;
ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
amended and restated certificate of incorporation requires that, unless we consent in writing to the selection of an alternative forum,
the Court of Chancery of the State of Delaware will, to the fullest extent permitted by law, be the sole and exclusive forum for each
of the following:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">any
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">provided,
that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter
jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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exclusive forum provision is limited to the extent permitted by law, and it will not apply to claims arising under the Exchange Act or for any other federal securities laws which provide for exclusive federal jurisdiction.</FONT></P>

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Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly,
both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions
and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate
of incorporation provides that the federal district courts of the United States of America will be the exclusive forum for resolving
any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice
of forum provisions are facially valid, a stockholder may nevertheless seek to bring such a claim arising under the Securities Act against
us, our directors, officers, or other employees in a venue other than in the federal district courts of the United States of America.
In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended
and restated certificate of incorporation.</FONT></P>

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we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits
to which it applies, this provision may limit or discourage a stockholder&#8217;s ability to bring a claim in a judicial forum that it
finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and
our directors, officers and other employees and may result in increased costs for investors to bring a claim. Alternatively, if a court
were to find the choice of forum provision contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable
in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect
our business and financial condition.</FONT></P>

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note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the
federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased
consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging
lawsuits against our directors and officers.</FONT></P>

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NOTE REGARDING FORWARD-LOOKING STATEMENTS</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">This
prospectus may contain certain forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify
forward-looking statements by terms such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;should,&#8221; &#8220;expect,&#8221; &#8220;plan,&#8221;
&#8220;anticipate,&#8221; &#8220;could,&#8221; &#8220;intend,&#8221; &#8220;target,&#8221; &#8220;project,&#8221; &#8220;estimate,&#8221;
&#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;predict,&#8221; &#8220;potential&#8221; or &#8220;continue&#8221; or the negative
of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date
of this prospectus and involve known and unknown risks, uncertainties and other important factors that may cause our actual results,
performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the
forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about
future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking
statements include, without limitation, statements about the following:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    commercialization, marketing and manufacturing capabilities and strategy;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    expected use of cash;</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our
    ability to identify, recruit, and retain key personnel;</FONT></P></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    expectations regarding the time during which we will be an emerging growth company under the JOBS Act;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Because
forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some
of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events
and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially
from those projected in the forward-looking statements. You should refer to the &#8220;Risk Factors&#8221; section of this prospectus
for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking
statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it
is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that
the forward-looking statements in this prospectus will prove to be accurate. Except as required by applicable law, we do not plan to
publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events,
changed circumstances or otherwise. You should, however, review the factors and risks and other information we describe in the reports
we will file from time to time with the SEC after the date of this prospectus.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">You
should read this prospectus, including the financial statements and notes to the financial statements included herein, with the understanding
that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these
cautionary statements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="TT_002"></FONT>MARKET
PRICE AND DIVIDEND INFORMATION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Market
Information</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in">Our common stock trades on Nasdaq under the
symbol &#8220;CING.&#8221;</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Holders
of Record</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of January 5, 2024, we had 206 holders of record of our common stock. The actual number of holders of our common stock is greater than
this number of record holders and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers
or held by other nominees. This number of holders of record also does not include stockholders whose shares may be held in trust by other
entities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Dividend
Policy</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Except
with respect to the stock dividend that was effective on September 20, 2021 for the purpose of establishing the correct number of shares
outstanding based upon our valuation prior to our initial public offering (&#8220;IPO&#8221;), we have never declared or paid
any dividends on our common stock. We currently intend to retain all available funds and any future earnings, if any, to fund the development
and expansion of our business, and we do not anticipate paying any cash dividends in the foreseeable future. Any future determination
to pay dividends will be made at the discretion of our Board.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="TT_003"></FONT>BUSINESS</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Overview</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company using our proprietary Precision Timed Release<SUP>TM</SUP> (PTR<SUP>TM</SUP>) drug delivery platform
technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering
from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial
focus on the treatment of Attention Deficit/Hyperactivity Disorder (&#8220;ADHD&#8221;) and anxiety, we are identifying and evaluating
additional therapeutic areas where our PTR technology may be employed to develop future product candidates. Our PTR platform incorporates
a proprietary Erosion Barrier Layer (EBL) designed to allow for the release of drug substance at specific, pre-defined time intervals,
unlocking the potential for once-daily, multi-dose tablets.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We are targeting the ADHD treatment
market, with an estimated US market size of over $23 billion as of November 2023, of which $18.6 billion is attributable to stimulants.
Stimulants are the most commonly prescribed class of medications for ADHD and account for approximately 88% of all ADHD medication
prescriptions in the United States. By contrast, non-stimulant medications are typically employed only in the second-line or adjunctive
therapy setting and accounting for approximately 12% of all ADHD medication prescriptions. Extended-release, or long-acting,
dosage forms of stimulant medications are most frequently deployed as the first-line treatment for ADHD and constitute approximately
$16 billion of the overall ADHD market spend and accounting for 54% of all stimulant prescriptions. Most of these extended-release dosage
forms are approved for once-daily dosing in the morning and were designed to eliminate the need for re-dosing during the day. However,
with the current &#8216;once-daily&#8217; extended-release dosage forms, most patients still receive a second or &#8220;booster&#8221;
dose for administration later in the day (typically in the early afternoon) to achieve active-day coverage and suffer from a multitude
of unwanted side effects as a result. We believe there is a significant, unmet need within the current treatment paradigm for true once-daily
ADHD stimulant medications with a duration that provides entire active-day coverage combined with an improved side effect
profile to better serve the numerous unmet needs of patients.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
two proprietary, first-line stimulant medications: CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), are being
developed for the treatment of ADHD across all three patient segments: children (ages 6 -12), adolescents (ages 13-17), and adults
(ages 18+). Both CTx-1301 and CTx-1302 are designed to address the key shortcomings of currently approved stimulant therapies by:
providing an immediate onset of action (within 30 minutes); offering entire &#8216;active-day&#8217; duration; eliminating the need
for &#8216;booster/recovery&#8217; doses of additional stimulant medications; minimizing or eliminating the rebound/crash symptoms
associated with early medication &#8216;wear-off;&#8217; and providing favorable tolerability with a controlled descent of drug
blood levels. Furthermore, by eliminating the &#8216;booster&#8217; dose used by up to 60% of ADHD patients in conjunction with
their primary medication, we believe our product candidates will provide important societal and economic benefits: reducing the
abuse and diversion associated with short-acting stimulant medications; allowing physicians to prescribe one medication versus two;
allowing patients to pay for one medication versus two; and allowing payers to reimburse one medication versus two.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
completed a proof-of-concept trial in human subjects to validate our PTR platform and in October 2020, announced positive results from
a Phase 1/2 study of CTx-1301 in ADHD patients establishing tolerability, comparative bioavailability, and dose proportionality of CTx-1301
versus Focalin&#174; XR. In order to meet the pharmacology requirement for the CTx-1301 NDA submission, we completed a food effect
study in October 2022, which demonstrated that CTx-1301 can be taken with or without food.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">A Phase 3 adult dose-optimization
study to assess the efficacy and safety, along with onset and duration, of CTx-1301 in adults with ADHD was initiated in December 2022
and completed in June 2023. Results were presented at the 2023 Psych Congress and will be presented at the 2024 American
Professional Society of ADHD and Related Disorders (APSARD) in January 2024. This Phase 3 CTx-1301study (NCT05631626) assessed efficacy
and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom
setting. It did not achieve statistical significance on the primary efficacy endpoint but CTx-1301 demonstrated a trend
toward significance in improving Permanent Product Measure of Performance (&#8220;PERMP&#8221;) scores compared to placebo. Clinical
Global Impression Scale (&#8220;CGI-S&#8221;) scores with CTx-1301 compared to placebo also showed significant improvements that
were indeed statistically significant for this secondary endpoint. The treatment effect size of CTx-1301 in this trial was notable
&#8211; starting at 30 minutes and demonstrated the ability of CTx-1301 to improve upon ADHD symptoms in patients over an entire active
day.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In addition, we initiated two
CTx-1301 Phase 3 clinical studies in pediatric and adolescent patients- a fixed dose study (NCT05286762) and a dose-optimized onset and
duration study in a laboratory classroom setting (NCT05924594) &#8211; in the third quarter of 2023. Based on guidance received from
the FDA regarding our clinical program for CTx-1301, we stopped enrollment in these two studies. All enrolled
patients in these studies can complete the study and data will be reported accordingly. Additionally, based on this guidance, we
expect to submit the NDA for CTx-1301 in the first half of 2025 under the Section 505(b)(2) pathway with Focalin&#174; XR as the reference
listed drug, using its efficacy and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence
data and efficacy/safety data from our CTx-1301 clinical program. If we receive FDA approval for CTx-1301, we may conduct Phase 4 trials.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We plan to initiate the clinical
plan for CTx-1302 (dextroamphetamine), our second investigational asset for the treatment of ADHD, as soon as 2025, pending additional
capital resources.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe that our PTR platform has the potential to provide patients and physicians with differentiated pharmaceutical treatment options
that will enhance patient compliance and improve health outcomes in several additional therapeutic areas. We intend to leverage our PTR
platform technology to expand and augment our clinical-stage pipeline by identifying and developing additional assets in other therapeutic
areas where one or more APIs need to be delivered several times a day at specific, pre-defined time intervals and released in
a manner that would offer significant improvement over existing therapies. Our criteria for the selection of additional, future pipeline
candidates will include the potential for $1 billion or more in peak annual sales, the potential to deliver a clearly differentiated
therapeutic advantage and the potential to overcome unmet medical needs.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are constructing a clinical program for CTx-2103 (buspirone), our anxiety candidate, under Section 505(b)(2) of the Federal Food, Drug,
and Cosmetic Act, which may result in a faster time to NDA submission. As part of that effort we presented results from the human formulation
study of CTx-2103 in September 2022 at the annual Psych Congress. Pharmacokinetics were evaluated for this trimodal tablet providing
three precisely timed doses of buspirone versus one immediate release dose. In addition, scintigraphic imaging visualized transit of
the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated with pharmacokinetic
data to establish the full release profile of the CTx-2103 formulation.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">CTx-2103 is being designed as
a novel, extended-release tablet of buspirone that incorporates our proprietary PTR&#8482; drug delivery platform. Buspirone,
an azapirone derivative and a 5-HT1A partial agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized
anxiety disorder. Buspirone may exhibit a decreased side-effect profile compared to other anxiolytic treatments. Unlike benzodiazepines
and barbiturates, there is no associated risk of physical dependence or withdrawal with buspirone use due to the lack of effects on gamma-aminobutyric
acid receptors.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">The positive results from the
human formulation study provided the critical information required and allowed us to request a Pre-IND meeting with the FDA to discuss
the design of our clinical and regulatory program for CTx-2103, which occurred in the fourth quarter of 2023. We received input
from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing of an IND. Based on this
FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2) pathway, which typically requires
less time and resources than the 505(b)(1) full NDA pathway.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In 2020, United States sales
for this of buspirone in various forms accounted for over $2 billion of sales in the $5.2 billion anxiety market. CTx-2103 will
be designed as a once-daily, modified-release tablet with clear differentiation and compelling advantages over standard treatment options
which must be taken multiple times per day to maximize efficacy. We are in active license conversations and, pending a definitive
agreement and additional capital resources, development of CTx-2103 (buspirone) for the treatment of anxiety may begin as soon
as 2025.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Clinical Development Pipeline</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Strategy</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
goal is to be a leading, innovative biopharmaceutical company focused on the development, manufacturing and commercialization of next
generation pharmaceutical products that utilize our PTR drug delivery platform technology to create dosing schedules and drug release
profiles that will improve the lives of patients suffering from a multitude of frequently diagnosed conditions. Key initial elements
of our business strategy to achieve this goal are to:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Complete
    development and obtain regulatory approval for CTx-1301 for the treatment of ADHD.</I></B></FONT></P>
                                                         <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>&#160;</I></B></FONT></P>
                                                         <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I></I></B></FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    October 2020, we announced positive results from a Phase 1/2 study of CTx-1301 in ADHD patients establishing tolerability,
    comparative bioavailability, and dose proportionality of CTx-1301 versus Focalin&#174; XR. A Phase 3 adult dose-optimization study
    to assess the efficacy and safety, along with onset and duration, of CTx-1301 in adults with ADHD was initiated in December 2022
    and completed in June 2023. Results were presented at the 2023 Psych Congress In addition we initiated two CTx-1301 Phase
    3 clinical studies in pediatric and adolescent patients- a fixed dose study and a dose-optimized onset and duration study in a laboratory
    classroom setting &#8211; in the third quarter of 2023. Based on guidance received from the FDA regarding our clinical
    program for CTx-1301 (dexmethylphenidate), enrollment in these two studies. All enrolled patients in these studies can complete
    the study and data will be reported accordingly. Additionally, based on this guidance, we expect to submit the NDA for CTx-1301
    in the first half of 2025 under the Section 505(b)(2) pathway with Focalin&#174; XR as the reference listed drug, using its efficacy
    and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence data and efficacy/safety
    data from our CTx-1301 clinical program.</FONT></P></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Successfully
                                            commercialize CTx-1301</I>.</B></FONT></P>
                                                                              <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0">&#160;</P>
                                                                              <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If we receive FDA approval for  CTx-1301, we plan to commercialize our lead candidate with the assistance of Indegene, Inc. In March 2023, we entered into to a Joint Commercialization Agreement with Indegene pursuant to which Indegene will provide commercialization services for CTx-1301, including marketing, sales, market access and distribution, on a fee for service basis.</FONT></P></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Advance
    clinical trials for CTx-2103 for the treatment of anxiety. </I></B>In September 2022, we announced that data from the human formulation
    study for CTx-2103 demonstrated its ability to deliver a single administration of triple-release buspirone. We will use these
    results to design the clinical program for CTx-2103, which will be designed as a once-daily, multi-dose tablet with what we believe
    will be clear differentiation and compelling advantages over standard treatment options. We are in active license conversations and
    pending a definitive agreement, development of CTx-2103 (buspirone) for the treatment of anxiety may begin as soon as 2025 pending
    additional capital resources. </FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Advance
                                            development of CTx-1302 for the treatment of ADHD. </I></B>We plan to initiate a clinical
                                            plan for CTx-1302 (dextroamphetamine), our second investigational asset for the treatment
                                            of ADHD, as soon as 2025 pending additional capital resources.</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Maximize
    the potential of our PTR platform to develop additional product candidates in new indications with significant unmet medical need
    and billion-dollar revenue potential. </I></B>We intend to use our PTR drug delivery platform technology and the streamlined 505(b)(2)
    development pathway to develop additional therapeutic assets in other therapeutic areas where one or more active pharmaceutical ingredients
    need to be administered several times a day at specific, pre-defined time intervals and released in a manner that would offer significant
    improvement over existing therapies. We believe this will lead to improved patient compliance and better health outcomes. Further
    indications we intend to evaluate include insomnia, non-opioid pain, Alzheimer&#8217;s, hypothyroidism, psychosis, depression, cardiovascular
    disorders, Parkinson&#8217;s disease, migraine, oral oncology, xerostomia (dry mouth) and bipolar disorder, among others.</FONT></TD></TR>
  </TABLE>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Acquire
    or in-license additional assets or programs to complement our portfolio and/or leverage our technology</I>. </B>We
    continuously evaluate potential partnering opportunities or asset acquisitions that can bolster our current product candidate portfolio
    and provide substantial value to our organization. We intend to focus on early to mid-stage development product candidates to generate
    clinical data and potentially move to later stages of development and ultimately on to commercialization.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Out-license
    our PTR platform to other companies and license our product candidates outside of the United States.</I></B> We are actively seeking
    and evaluating opportunities to license our current assets and the PTR drug delivery platform technology to other companies looking
    to serve large patient populations with unmet needs and/or looking to transform multiple daily dosing to once
    daily administration to satisfy patient needs. We are also in on-going conversations to pursue and evaluate opportunities to license
    our product candidates to third parties for use outside of the United States.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Further
    strengthen our intellectual property portfolio</I></B>. We intend to continue to manage and expand our diverse intellectual property
    portfolio and maintain our trade secrets and know-how focused on our PTR platform, current and future pipeline candidates, and proprietary
    manufacturing process. We believe these activities will be critical to protect our platform and product candidates from potential
    competitors that may try to compete with our therapeutic assets and compression tableting approach.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Capitalize
    on our existing cGMP expertise.</I></B> We have developed a proprietary, reliable, high output, specialized manufacturing equipment
    with the potential for real-time testing and release that is employed by our third-party manufacturing partner. Our process has been
    designed to allow for the creation of a platform that can incorporate other drug substances thus permitting expansion into additional
    indications and therapeutic areas. We expect that our investment in these manufacturing capabilities and equipment will substantially
    reduce our development timelines and overall development costs for current and future assets. We currently utilize commercial manufacturing
    equipment and will not require technology transfer or large scale-up processes to meet clinical or commercial manufacturing needs.
    In October 2022, we announced that we have selected Societal CDMO, Inc. (&#8220;Societal&#8221;) as our new contract development
    and manufacturing organization (&#8220;CDMO&#8221;) that will manufacture all clinical, registration, and commercial batches
    of our lead candidate CTx-1301. Societal has dedicated a specific manufacturing suite within its Gainesville, GA facility and outfit
    it with proprietary equipment supplied by us. </FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Team</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
founders and management team have many years of experience in the biopharmaceutical space, holding management positions at leading biopharmaceutical
companies, including Pfizer Inc., Novartis International AG, DuPont de Nemours, Inc. and Sanofi S.A., among others. Our team possesses
substantial experience and expertise across the spectrum of drug development and commercialization of pharmaceutical products, including
multiple psychiatric and nervous system products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Shane
J. Schaffer, our Co-Founder, Chairman and Chief Executive Officer, has held senior leadership roles at Pfizer Inc., Novartis International
AG and Sanofi S.A. and has over 25 years of experience in drug development and commercialization. Dr. Matthew Brams, our Co-Founder and
Chief Medical Officer, has over 30 years of clinical experience managing patients in the field of adult and child psychiatry and has
been involved in the research, development, and evaluation of multiple ADHD medications. Dr. Raul R. Silva, our Co-Founder and Chief
Science Officer, is a practicing child and adolescent psychiatrist who has served as Associate Professor and Vice Chairman of Child and
Adolescent Psychiatry at NYU School of Medicine in New York City. Laurie A. Myers, our Chief Operating Officer, has held leadership positions
for leading global pharmaceutical companies, including Pfizer Inc., Novartis International AG, DuPont de Nemours, Inc. and Sanofi S.A.
and has over 25 years of experience in drug development, marketing and commercialization.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>ADHD
Overview and Drawbacks of Current Therapies</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">ADHD
is a chronic neurobehavioral and developmental disorder that affects millions of children, adolescents and adults. In the United States,
approximately 6.4 million, or 11%, of children and adolescents aged 4-17 have been diagnosed with ADHD. Among this group, 80% receive
treatment and 65% demonstrate clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence in the United States is estimated
at approximately 11 million patients, or 4.4%, of the population, almost double the size of the child and adolescent segment combined.
Currently, approximately 20% of the adult ADHD population receives treatment, however an increasing number of adult patients are being
diagnosed and seeking treatment causing the adult ADHD market to grow approximately 10% year over year. Total ADHD medication sales in
the United States continue to grow with sales of all ADHD medications reaching over $23 billion for the 12-months ended November 2023.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">ADHD
is marked by an on-going pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning and/or development.
According to the American Academy of Child and Adolescent Psychiatry, common manifestations of ADHD in children and adolescents include:</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Hyperactivity</FONT>:
Children always seem to be in motion. A child who is hyperactive may move around touching or playing with whatever is around, or talk
continually. During story time or school lessons, the child might squirm around, fidget, or get up and move around the room. Some children
wiggle their feet or tap their fingers. A teenager or adult who is hyperactive may feel restless and need to stay busy all the time.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Impulsivity</FONT>:
Children often blurt out comments without thinking first. They may often display their emotions without restraint. They may also fail
to consider the consequences of their actions. Such children may find it hard to wait in line or take turns. Impulsive teenagers and
adults tend to make choices that have a small immediate payoff rather than working toward larger delayed rewards.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Inattentiveness</FONT>:
Inattentive children may quickly get bored with an activity if it&#8217;s not something they really enjoy. Organizing and completing
a task or learning something new is difficult for them. As students, they often forget to write down a school assignment or bring a book
home. Completing homework can be huge challenge. At any age, an inattentive person may often be easily distracted, make careless mistakes,
forget things, have trouble following instructions, or skip from one activity to another without finishing anything.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Adult
ADHD patients typically suffer from restlessness, impulsivity, difficulty with time management, trouble regulating emotions and difficulty
managing finances. Adults with ADHD report experiencing an internal sense of fidgetiness and restlessness and experience greater difficulty
communicating with others. Upon entering the job market, many adults have difficulty gaining employment and are at increased risk of
termination due to repeated tardiness or absenteeism. Adults with ADHD earn approximately 30% less and are 10% less likely to be employed
versus their unaffected peers. Additionally, adults with ADHD are more likely to exhibit a variety of comorbidities including drug and
alcohol abuse, social anxiety and depression.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">ADHD
in both children and adults has an impact not only on the individual but on their families, friends and peers and because of its prevalence
as one of the most commonly diagnosed behavioral disorders, a critical impact on society, the healthcare system and the economy at large.
On a societal level, versus control groups, ADHD patients experience a greater than 40% higher rate of vehicle accidents, 2x greater
divorce rate, have a 2-fold greater incidence of accidental death, and research from prospective studies indicates that children and
adults with ADHD have approximately twice the incarceration rate. On an economic level, in the United States alone, national annual incremental
cost of ADHD ranged from $143 billion to $266 billion.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Although
there is no single medical, physical, or genetic test for ADHD, qualified mental health care professionals and physicians are able to
provide a diagnostic evaluation after gathering information from multiple sources including ADHD symptom checklists, standardized behavior
rating scales, detailed histories of past and current functioning, and information obtained from close family members or significant
others. Some practitioners will also conduct tests of cognitive ability and academic achievement in order to rule out a possible learning
disability.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Stimulants
are the most commonly prescribed class of medications for ADHD, accounting for approximately 88% of all ADHD medication prescriptions.
Stimulants are Schedule II controlled substances and are believed to work by enhancing the effects of dopamine and norepinephrine neurotransmitters
in the brain. Approximately 82 million stimulant prescriptions were written during the 12-months ended November 2023. In contrast, non-stimulant
medications are typically deployed as second line or adjunctive therapies and account for 12% of all ADHD medication prescriptions. Currently,
the ADHD market is dominated by four main stimulant medications: Vyvanse&#174;, Adderall&#174; XR, Concerta&#174;, and Focalin&#174; XR.
These products were approved and became available between 2000 and 2007 and were believed to revolutionize the ADHD treatment paradigm
by finally providing a solution to avoid the late morning second dose of stimulant medication then required by ADHD patients.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unfortunately,
as designed, all four of the mostly commonly prescribed stimulant drugs deliver all the drug substance during the morning hours. As a
result, most patients still require additional medication to cover the remainder of their active day. Currently, 60% of ADHD patients
require an afternoon &#8216;booster/recovery&#8217; dose due to lack of duration, slow onset of efficacy, and the crash or rebound effects
in the early afternoon. Additionally, their PK-PD release profiles are such that they leave patients significantly impaired by crash
and rebound effects even while on therapy.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patients
and practitioners report, that an ideal ADHD stimulant medication would provide <B><I>all </I></B>of the following characteristics: entire
active-day duration ; immediate onset of action (within 30 minutes); ability to minimize or avoid crash / rebound effects associated
with rapid decline in medication blood levels; and elimination of the need for short-acting stimulant booster/recovery doses.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
chart above is based upon the Package Inserts and Summary Basis of Approvals for the approved products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_005.jpg" ALT="" STYLE="height: 268px; width: 670px"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
chart above is based upon the Package Inserts and Summary Basis of Approvals for the approved products.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
recent years, the FDA has approved additional stimulant medications that were designed to meet some of the remaining unmet needs. Chewables,
liquids and oral disintegrating tablets have come to market as has one product with an evening dosing schedule intended to provide early
morning onset. None of these products have been able to meet all of the unmet needs of ADHD patients and prescribers and consequently
all have failed to gain traction as first-line agents. Furthermore, these recent stimulant medications, based on their market share,
appear to offer little advantage over widely available generic products for healthcare practitioners and their patients. They have proven
to be niche remedies occupying a combined 2.0% of the total ADHD prescriptions written in the United States in 2020. Thus, there is an
unmet need for a true once-daily dose providing a fast onset of action, minimization or elimination of the crash/rebound, elimination
of the booster/recovery dose, and most importantly, providing entire &#8216;active-day&#8217; efficacy.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
chart above is based upon the Package Inserts and Summary Basis of Approvals for the approved products.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Solution: Our Proprietary Precision Timed Release Drug Delivery Platform Technology</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are developing medications capable of achieving true once-daily dosing using our internally developed PTR drug delivery platform technology.
Our CTx-1301, CTx-1302 and CTx-2103 drug candidates contain three releases of active pharmaceutical ingredient combined into one small
tablet dosage form (smaller than many comparable single dose ADHD products). Each release of API is separated with a proprietary EBL,
a functional excipient that is designed to gradually erode throughout the day to provide controlled drug release at specific time intervals,
allowing for a favorable target efficacious period.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Illustration
of Our PTR Platform Film-Coated Tablet</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Size
Comparison of CTx-1301 Tablet versus Common ADHD and Other Medications</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_008.jpg" ALT="Different types of pills&#10;&#10;Description automatically generated" STYLE="height: 351px; width: 560px"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe our PTR technology affords our drug candidates the following advantages over currently available ADHD treatments:</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Fast
Onset. </I></B>Many currently available therapies often take up to 60 minutes or longer to start working and thus can leave patients
with long gaps between dosing and onset. In an effort to minimize this onset gap, patients will often wake up early to take their medication
and attempt to go back to sleep until the medication takes effect. We have designed our drug candidates to be fast-acting so they can
be taken in the morning when the patient starts their day, not predawn while they wait for onset.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Elimination
of Need For Additional Stimulant Boosters. </I></B>With entire active-day coverage, we believe our technology will eliminate the need
for patients to take afternoon booster doses when their currently prescribed therapies wear off. By eliminating the need for a booster
dose, we believe our candidates will cause less embarrassment for patients, especially child and adolescent patients who are often forced
to take a second dose while at school surrounded by classmates and increase patient compliance especially in the ADHD population where
patients are prone to forget to take the additional dose they need to get through their active day.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Lower
Abuse Potential. </I></B>We believe our fast onset and entire active-day solution for ADHD patients, if approved, will lower the incidence
of short-acting stimulant drug abuse and diversion. We believe by eliminating the need for the short-acting stimulant booster dose, the
potential for illicit sales and recreational use that often comes as a result of patients carrying short-acting Schedule II controlled
substances to school or work for afternoon dosing will decrease.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Elimination
Crash and Rebound Symptoms. </I></B>Patients on currently available therapies may report adverse effects or a flare of ADHD symptoms
as their medications wear off; these effects are termed &#8220;crash&#8221; and &#8220;rebound.&#8221; Using our precise timing, ratio,
and style of drug delivery, we believe our candidates provide a controlled descent of blood levels, eliminating this uncomfortable experience
for patients<I>.</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Lower
Cost</I>.</B> By providing entire active-day efficacy, our drug candidates eliminate the need for doctors to prescribe more than one
medication lowering the overall cost of the condition to individual patients and within the healthcare system at large. Furthermore,
generic medications in the stimulant ADHD category are not tremendously less expensive as they are in other categories of non-controlled
medications. Generic stimulant medications cost anywhere from 55%-90% of the cost of their brand counterparts. We believe, if approved,
our drug candidates will offer a much more cost-effective solution to patients.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Significantly
Improved Tolerability.</I></B> Because of the PK and PD profile of our drug, we believe patients will experience fewer treatment related
adverse events associated with existing stimulant therapies including insomnia, appetite suppression, and feelings of extreme restlessness,
dysphoria, irritability, fatigue, and flattening of affect.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Availability
in Eight Dosage Strengths at Launch and Single-Enantiomer API Selection</I>.</B> Our CTx-1301 and CTx-1302 product candidates are both
round film-coated tablets that we intend to provide in eight matching dosage strengths. We believe providing practitioners with the ability
to properly titrate and optimize their patients&#8217; daily dosing needs is critical. By having eight dosage strengths at launch, practitioners
will not have to constantly switch their patients to other medications or supplement patients with more short-acting booster medications.
In addition, we believe that eight dosage strengths will allow healthcare practitioners to appropriately treat the range of patients
in their practice, from early childhood through adulthood. Medications that have launched with three dosage strengths are often ignored
or avoided until at least six or seven strengths are available. Both CTx-1301 and CTx-1302 contain APIs that are Schedule II controlled
substances. The APIs of both product candidates utilize just one of the multiple enantiomers, which may result in improvements in potency,
adverse events (Aes), and drug interactions profiles along with an enhanced therapeutic index.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Lead Candidate CTx-1301: Dexmethylphenidate for the Treatment of ADHD in 6 Years and Older</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe our most advanced drug product candidate, CTx-1301, will be the first true once-daily dexmethylphenidate tablet for the treatment
of ADHD, providing onset-of-action within 30 minutes and entire &#8216;active-day&#8217; efficacy. CTx-1301 is a trimodal extended-release
tablet, based on tablet-in-tablet technology, which provides three distinguishing releases of dexmethylphenidate hydrochloride at precise
times, ratio, and modality of release. Our CTx-1301 release profile is as follows:</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
#1: An initial immediate-release, or IR, dose providing 35% of the total daily dose beginning within five to six minutes after administration
and designed to achieve therapeutic efficacy within 30 minutes; and</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
#2: Three hours after the administration of the dosage form, the first delayed, sustained release (DR1) provides 45% of the total daily
dose released over 90 minutes; and</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
#3: Seven hours after the administration of the dosage form, a second delayed, immediate release (DR2, the built-in-booster) provides
20% of the total daily dose released over approximately 30 minutes.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Release
Comparison of CTx-1301 versus Focalin XR (Reference Listed Drug)</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_009.jpg" ALT="A graph showing the growth of a number of active-day&#10;&#10;Description automatically generated" STYLE="height: 247px; width: 576px"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
proprietary, trimodal release profile is engineered to provide patients with a rapid onset of relief from symptoms and to maintain that
relief throughout the entire active day. Further, we believe CTx-1301 will continue to demonstrate a more favorable tolerability profile
that results from this specialized three-release design and unique 35%-45%-20% release profile, compared to the currently available 50%-50%
or 33%-33%-33% release profile that would be produced if a patient were to take three individual doses of dexmethylphenidate in the same
milligram strengths. CTx-1301 delivers a release profile that cannot be replicated with commercially available (branded or generic) short
and long-acting formulations and was precisely engineered and designed to meet the specific needs of ADHD patients and providers.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect CTx-1301 film-coated tablets to be available in eight dosage strengths ranging from 6.25mg to 50mg of dexmethylphenidate. All
excipients are compendial and/or non-novel, well established for use in oral formulations, and are present in the drug product at levels
well below their maximum potencies listed in FDA&#8217;s inactive ingredient database (IID).</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
CTx-1301 Clinical Development Program</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
proposed clinical program for CTx-1301 consists of two Phase 1/2 clinical pharmacology studies and our Phase 3 Mastery clinical efficacy
and safety trials.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Our
Phase 1/2 Bioavailability Trial Results</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In October 2020, we announced
positive results from a Phase 1/2 comparative bioavailability study in ADHD subjects, under fasted conditions, and demonstrated similar
bioavailability to our RLD, Focalin XR. Adjusted geometric mean ratios of primary exposure parameters (C<SUB>max</SUB>, AUC<SUB>0-inf</SUB>,
and AUC<SUB>last</SUB>) between CTx-1301 and Focalin XR were within the required 80% to 125% range, both at the high and the low doses,
demonstrating a bridge to the RLD as well as dose proportionality. There were no unexpected adverse events, no serious adverse events,
no deaths, and no other safety signals observed during this study.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Key
Findings</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Bridged
to Focalin&#174; XR</FONT></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Confirmed
    similar bioavailability to Focalin XR and confirmation of our ability to utilize the 505(b)2 pathway</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Demonstrated
    dose proportionality, allowing us to avoid the need to evaluate all individual strengths <I>in vivo</I></FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Eliminated
    any requirement for nonclinical studies and ability to utilize existing safety from the Focalin XR label, potentially resulting in
    a faster pathway to market</FONT></TD></TR>
  </TABLE>
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Plasma Levels versus Focalin&#174; XR </FONT></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CTx-1301
    blood levels demonstrated the potential for a fast onset, active-day duration, and favorable tolerability.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Performed
    as designed, with its precise 20% &#8216;built-in-booster&#8217; 3rd delivery confirming that if approved, CTx-1301 would eliminate
    patients need for short-acting stimulants and avoid the potential for non-ideal blood levels that could impact normal sleep and appetite</FONT></TD></TR>
  </TABLE>
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Controlled Descent of Plasma Levels versus Focalin&#174; XR</FONT></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Precise
    20% 3rd delivery stopped the mid-afternoon plummeting of blood levels, controlling the decline.</FONT></TD></TR>
  </TABLE>
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Significantly Lower Treatment Emergent Adverse Events</FONT></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patients
    received 25% more medication via the PTR Platform in a precisely timed, unique ratio</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CTx-1301
    patients experienced a 28.6% reduction of TEAE&#8217;s related to study drug versus Focalin XR</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
comparative bioavailability data study versus Focalin XR is presented in Figure 1, Figure 2, and Figure 3</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Figure
1: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in Adult ADHD subjects under Fasted Conditions (low dose comparison)</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_010.jpg" ALT="A graph showing the number of data&#10;&#10;Description automatically generated with medium confidence" STYLE="height: 283px; width: 576px"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Figure
2: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in Adult ADHD subjects under Fasted Conditions (high dose)</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Figure
3: Comparative Bioavailability Study of CTx-1301 versus Focalin XR in individual Adult ADHD subjects under Fasted Conditions (low and
high dose)</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Additional Phase 1 Study</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
completed a Phase 1 Food Effect study in October 2022. Primary endpoints demonstrated that CTx-1301 can be taken with or without food.</FONT></P>

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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Fast-Fed
    Study</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    Phase 1, open-label, randomized, single-dose, two-period, two-treatment (fed vs fasted), two-sequence, crossover study in 23 healthy
    adult subjects, 18-50 years of age, to assess the effect of food on the absorption and bioavailability of CTx-1301</I>. The objectives
    of this study were to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single
    dose of CTx-1301. Secondary objectives were to provide pharmacokinetic data on blood plasma levels of CTx-1301 in both a fasted and
    fed state, and to evaluate the safety of a single dose of CTx-1301 25 mg tablet. Exploratory objectives were to further explore the
    characteristics of CTx-1301 25 mg tablet within selected time intervals.</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Phase 3 MASTERY Trials</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
Phase 3 adult dose-optimization study to assess the efficacy and safety, along with onset and duration, of CTx-1301 in adults with ADHD
was initiated in December 2022 and completed in June 2023. Results were presented at the 2023 Psych Congress and will be
presented at the 2024 American Professional Society of ADHD and Related Disorders (APSARD) in January 2024. This Phase 3 CTx-1301study
(NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD
in an adult laboratory classroom setting. It did not achieve statistical significance on the primary efficacy endpoint but CTx-1301
demonstrated a trend toward significance in improving PERMP scores compared to placebo. CGI-S scores with CTx-1301 compared to placebo
also showed significant improvements that were indeed statistically significant for this secondary endpoint. The treatment effect
size of CTx-1301 in this trial was notable &#8211; starting at 30 minutes and demonstrated the ability of CTx-1301 to improve upon ADHD
symptoms in patients over an entire active day.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I><FONT STYLE="text-decoration: underline">Key
Findings</FONT></I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
PERMP is a skill-adjusted math test deployed in this Phase 3 study. The PERMP score is the sum of the number of math problems attempted
plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating
better performance.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_012.jpg" ALT="A graph of different colored bars&#10;&#10;Description automatically generated with medium confidence" STYLE="height: 185px; width: 318px"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.5in; text-align: justify">The CGI-S is a single-item scale that measures
the severity of psychopathology from 1-7 and was measured during this Phase 3 study in adults.</P>
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RPCP: Randomized Double-Blind Placebo Controlled Period</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The AISRS, or ADHD
Rating Scale is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (American Psychiatric
Association 2013) which evaluates the criteria of ADHD and rates symptoms on a 4-point scale and was also measured in this adult study.
Each item is scored using a combination of severity and frequency ratings from zero (reflecting no symptoms or a frequency of never or
rarely) to three (reflecting severe symptoms or a frequency of very often), so that the total AISRS-5 scores range from zero to
54.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_015.jpg" ALT="A graph of a patient's performance&#10;&#10;Description automatically generated" STYLE="height: 218px; width: 313px"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
Phase 3 CTx-1301 diagnostic tools and ADHD evaluations including the AISRS-5, the CGI-S, and the PERMP are commonly used as
study endpoints in support of an NDA filing.</FONT></P>

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Phase 3 CTx-1301 clinical safety and efficacy studies also include two child and adolescent studies which were initiated in the third
quarter of 2023:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    Phase 3, dose-optimized, randomized, double-blind, placebo-controlled, single-center, parallel-group efficacy and safety laboratory
    classroom study in</I> children (6-12) with ADHD. The primary objective is to evaluate the efficacy of CTx-1301 compared to
    placebo in treating children with ADHD in a laboratory classroom study using the PERMP. Secondary objectives are to determine
    onset and duration of clinical effect of CTx-1301 and to determine safety and tolerability of CTx-1301 compared to placebo.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group, efficacy and safety study in children
    and adolescent (6-17 y/o) with ADHD.</I> The primary objective is to evaluate the efficacy of a fixed dose of CTx-1301 compared to
    placebo using the ADHD-RS-5. Secondary objectives are to evaluate the efficacy of a fixed dose of CTx-1301 compared to placebo using
    the CGI-S, safety and tolerability of a fixed dose of CTx-1301, and PK levels after a single dose and at steady state.</FONT></TD></TR>
  </TABLE>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Exploratory
    objectives will be evaluated in the adult dose-optimization study to define and evaluate the unique benefits and satisfaction of
    optimized treatment with CTx-1301 against prior therapies using patient reported outcomes (&#8220;PROs&#8221;). The PRO evaluation
    will include:</FONT></TD></TR>
  </TABLE>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Subjects
    required use of &#8220;booster&#8221; doses for entire active-day efficacy, avoidance of wear-off effect, crash/rebound, and abuse/diversion
    of short-acting stimulants.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Compare
    overall treatment satisfaction of prior therapies versus CTx-1301.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Compare
    adverse events of prior therapies versus CTx-1301.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Evaluate
    importance of a true, once-daily treatment for ADHD.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Evaluate
    the incidence of abuse and/or diversion of short-acting booster doses.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Evaluate
    important differentiators for patients requiring ADHD treatment by providing a complete solution with entire active-day efficacy,
    fast onset of action, avoiding crash/rebound, and eliminating the required short-acting stimulant booster/recovery dose.</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
exploratory measures will not only provide critical information for clinicians but also provide important data to payers and market access
teams.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">Based on
guidance received from the FDA regarding our clinical program for CTx-1301, we stopped enrollment in these two studies.
All enrolled patients in these studies can complete the study and data will be reported accordingly. Additionally, based on this guidance,
we expect to submit the NDA for CTx-1301 in the first half of 2025 under the Section 505(b)(2) pathway with Focalin&#174; XR as the reference
listed drug, using its efficacy and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence
data and efficacy/safety data from our CTx-1301 clinical program. If we receive FDA approval for CTx-1301, we may conduct Phase 4 trials.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CTx-1302:
Dextroamphetamine for the treatment of ADHD in 6 years and older</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
believe our drug product candidate CTx-1302, will be the first true once-daily dextroamphetamine tablet for the treatment of ADHD, providing
onset-of-action within 30 minutes and efficacy for the entire active day. CTx-1302 is a trimodal extended-release tablet, based on tablet-in-tablet
technology, that provides three releases of dextroamphetamine at precise times, ratio, and modality of release. Our CTx-1302 release
profile is as follows:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
    #1: An initial immediate-release, or IR, dose providing 45% of the total daily dose begins within five to six minutes after administration
    is designed to achieve therapeutic efficacy within 30 minutes; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
    #2: Three hours after the administration of the dosage from, the DR1 provides 35% of the total daily dose released over 90 minutes;
    and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Release
    #3: Seven hours after the administration of the dosage form, a DR2, the built-in-booster provides 20% of the total daily dose released
    over approximately 30 minutes.</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect CTx-1302 tablets will be available in eight dosage strengths ranging from 6.25mg to 50mg of dextroamphetamine. All excipients
are compendial and/or non-novel, well established for use in oral formulations, and are present in the drug product at levels well below
their maximum potencies listed in FDA&#8217;s IID.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
CTx-1302 Clinical Development Program</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
proposed clinical program for CTx-1302 consists of Phase 1/2 clinical pharmacology studies and Phase 3 clinical efficacy and safety
trials. We plan to initiate a Phase 1/2 bioavailability study in ADHD patients for CTx-1302 in 2025 and, if the results from this study
are successful, subsequently initiate pivotal Phase 3 clinical trials, the branded ACCOMPLISH trials, in late 2025 or early 2026; all
dependent on capital resources. Our Phase 1/2 trials are expected to include approximately 100 patients and the Phase 3
clinical plan will include approximately 500 patients.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Our
Planned Phase 1 Trials</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
proposed Phase 1 CTx-1302 clinical pharmacology studies include:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Phase
    1/2 Comparative Bioavailability Study:</I> To evaluate and compare the pharmacokinetic profile of CTx-1302 to the RLD, Dexedrine
    Spansule in adults with ADHD (18+ y/o).</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Phase
    1 Food Effect Study:</I> To evaluate the pharmacokinetic profile of CTx-1302 under fed and fasted conditions in adults (18+ y/o).</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Phase
    1 Single-Dose, Fully-Replicate Crossover Study:</I> To evaluate the intra-subject variability of the in vivo pharmacokinetic profile
    of CTx-1302 to the RLD, Dexedrine Spansule in adults (18+ y/o).</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Planned
Phase 3 ACCOMPLISH Trials</B></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    Phase 3, fixed-dose, parallel-design, placebo-controlled, 5-week study in children and adolescent patients (6-17 y/o). </I>The primary
    efficacy endpoint is the ADHD-RS-5. The Clinical Global Improvement Severity Scale (CGI-S) will be evaluated as a secondary endpoint.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    Phase 3, analog workplace efficacy and safety study in adults (18+): </I>The primary efficacy endpoint is the PERMP. Time to onset
    and duration of effect will also be evaluated as key secondary endpoints.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>A
    long-term dose-optimization safety study will evaluate safety of the pediatric population (6-17 y/o) for six months.</I> This study
    will collect and monitor any adverse events that occur during the timeframe of the study.</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Important
exploratory endpoints included in the analog Phase 3 protocols will define and evaluate the unique benefits and satisfaction of optimized
treatment with CTx-1302 against prior therapies using PROs similar to those from the CTx-1301 Phase 3 plan.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect the 505(b)(2) NDA filing for CTx-1302 will use Dexedrine&#174; Spansule&#174; as a reference drug, using as a basis for approval
that drug&#8217;s efficacy and safety data on file at FDA, together with bioavailability/bioequivalence data and efficacy/safety data
from our CTx-1302 clinical program.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a complete Phase 3 safety and efficacy studies package will be required for CTx-1302 we can expect that similar diagnostic tools and
ADHD evaluations including the ADHD-RS-5, the CGI-S, and the PERMP will be incorporated as in CTx-1301. However, based on our current
knowledge about the clinical program for CTx-1301, we may again approach the FDA for their guidance on an alternate, more cost and time
efficient approach for CTx-1302.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CTx-2103:
Buspirone product candidate for the treatment of anxiety related disorders</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We have embarked on a program
to develop CTx-2103 (buspirone) for the treatment of anxiety, which is the most common mental health concern in the United States
We believe CTx-2103 has the potential to be the first once-daily formulation of buspirone, one of the most widely prescribed agents
in the anxiety market. CTx-2103 is a novel, extended-release tablet that contains the active pharmaceutical ingredient buspirone hydrochloride,
a non-benzodiazepine medication, for which there is no evidence of the development or risk of dependency. However, due to its short half-life,
buspirone is prescribed to be taken several times a day for management of anxiety, which can be challenging for patients and may lead
to sub-optimal treatment outcomes. CTx-2103 will be designed as a once-daily, multi-dose tablet, which we believe will offer clear differentiation
and compelling advantages over currently available treatment options.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our
CTx-2103 Clinical Development Program</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
June 2022, we completed a human formulation study for CTx-2103. The first human subject study of CTx-2103 was a single-center, open-label,
four-arm crossover study in 10 healthy subjects. Each participant received four different doses of buspirone at different assessment
visits: one timed-release 10mg tablet releasing drug after a four-hour delay, one timed-release 10mg tablet releasing drug after an eight-hour
delay, one triple-pulse 10mg tablet releasing drug at zero, four and eight hours, and one immediate release 10mg tablet of generic buspirone
(the reference product, which is a commercially available formulation).</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
primary objective was to evaluate the absorption of buspirone and the presence of metabolite 1-pyrimidinylpiperazine (1-PP) in blood
plasma from time-delayed formulations and correlate this with scintigraphic time and site of release data. Secondary objectives of the
study will compare the pharmacokinetic performance of the time delayed buspirone products with a commercially available formulation.
Additionally, the study will evaluate the absorption of buspirone and the presence of metabolite 1-PP in blood plasma from a triple-release
product.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Safety
evaluations demonstrated that CTx-2103 is safe and well tolerated. No serious, severe, or clinically meaningful treatment-emergent adverse
events (&#8220;TEAEs&#8221;) occurred during this study. Most TEAEs were mild in severity and were consistent with events expected
for buspirone. The evaluation of TEAEs, laboratory examinations, physical examinations, ECG recordings, and measurement of vital signs
(blood pressure and pulse rate) revealed no safety concerns for buspirone.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Based on the pharmacokinetic
profile seen in the data from the formulation study, CTx-2103 achieved a triple release of buspirone hydrochloride The positive results
from this human formulation study provided the critical information needed for us to request a Pre-IND meeting with the
FDA to discuss the design of our clinical and regulatory program for CTx-2103. The Pre-IND meeting occurred in the fourth quarter
of 2023. We received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical studies for filing
of an Investigational New Drug (&#8220;IND&#8221;). Based on the FDA&#8217;s feedback, CTx-2103 may be able to seek and
win approval under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Commercialization</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Given
our stage of development, we do not currently have any internal sales, marketing, or distribution infrastructure or capabilities. If
CTx-1301 and/or CTx-1302 are approved, we plan to pursue commercialization of our product candidates in the United States, which we expect
will be the first country in which we receive market authorization. We will need a commercial collaboration partner to benefit from their
ability to provide us with more immediate access to marketing, sales, market access and distribution infrastructure to allow us to communicate
with the majority of the high-volume neurology and psychiatry prescribers of ADHD medications and the high prescribing ADHD pediatricians
and family practice providers.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, we would expect to use multi-channel tactics, including non-personal strategies, to reach physicians, payers, patients and
patient caregivers with the right frequency to help drive behavior. In addition to personal promotion, we intend to reach physicians
through medical education, direct marketing, journal advertising and electronic health record communication. Advocacy groups, patients
and caregivers are extremely active and vocal in the ADHD space. We expect that a direct-to-patient strategy would allow us to access
this social group through focused education and advertising, as well as by employing appropriate social media listening and engagement
to inform these patients and caregivers.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In March 2023, we entered into
to the Commercialization Agreement with Indegene. If we receive FDA approval for CTx-1301, Indegene is poised to provide commercialization
services for CTx-1301 pursuant to statements of work that will set forth, among other things, the services to be performed by Indegene,
the deliverables for such services and the fees to be paid by us. Key services that Indegene is expected to provide, include: (a) medical
affairs &amp; pharmacovigilance; (b) pricing, reimbursement and market access; (c) commercial operations; and (d) marketing (including
field force). See &#8220;Material Agreements &#8211; Joint Commercialization Agreement with Indegene, Inc.&#8221; below. Cingulate is
also considering a strategic pharmaceutical partnership under which Cingulate would co-promote or out-licenses CTx-1301
in the United States, outside the United States, or both. Cingulate is pursing opportunities on all fronts and we
have partnered with a well-known business development company, Global Pharmaceutical Partners (&#8220;GPP&#8221;). They are actively
seeking to identify viable licensing partners.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Manufacturing</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not currently own or operate a manufacturing facility. Previously, we utilized Pharmaceutical Manufacturing Research Services, Inc.
as our CDMO for the manufacture of our products used in pre-clinical research and clinical trials. In October 2022, we retained Societal
CDMO, Inc. (&#8220;Societal&#8221;) as our new CDMO that will manufacture all clinical, registration, and commercial batches of
our lead candidate CTx-1301. Societal will dedicate a specific manufacturing suite within its Gainesville, GA facility and outfit it
with proprietary equipment owned by us.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
third-party manufacturers, facilities, and all lots of drug substance and drug products used in our clinical trials are required to be
in compliance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities,
equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls,
holding and distribution, laboratory controls, records and reports, and returned or salvaged products. The manufacturing facilities where
our products are produced must meet cGMP requirements and FDA satisfaction before any product is approved and we can manufacture commercial
products. Any third-party manufacturers are also subject to periodic inspections of facilities by the FDA and other authorities, including
procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations. In
addition, our drug products are classified as Class II controlled substances which requires any future third-party manufacturers to be
approved and regulated by the DEA.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Drug
Substance</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We currently purchase the APIs
used in CTx-1301 (Dexmethylphenidate); CTx-1302 (Dextroamphetamine) and CTx-2103 as well as excipients from third-party manufacturers
based in the United States. We anticipate entering into commercial supply agreements with many of these manufacturers in the future.
The APIs for both CTx-1301 and CTx-1302 are controlled under United States federal law. Dexmethylphenidate, and dextroamphetamine
are classified by the DEA as Schedule II controlled substances. As with all stimulate medications, there is a potential for abuse. Consequently,
our procurements, manufacturing, shipping, dispensing and storing of our product candidates will be subject to regulation, as described
in more detail under the &#8220;DEA Regulation&#8221; section included elsewhere in this prospectus. The API for CTx-2103 (buspirone)
is not as scheduled controlled substance therefore additional DEA regulations will not apply.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Intellectual
Property</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Proprietary
protection</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
commercial success depends in part on our ability to obtain and maintain proprietary protection for our drug candidates, manufacturing
and process discoveries and other know-how, to operate without infringing the proprietary rights of others, and to prevent others from
infringing on our proprietary rights. We have been building and continue to build our intellectual property portfolio relating to our
ADHD drug candidates, and our innovative proprietary PTR drug delivery platform technology, and our technology platform. Our policy is
to seek to protect our proprietary position by, among other methods, filing United States and certain foreign patent applications
related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business.
We also intend to rely on trade secrets, know-how, continuing technological innovation, and potential in-licensing opportunities to develop
and maintain our proprietary position. We cannot be sure that patents will be granted with respect to any of our pending patent applications
or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents
that may be granted to us in the future will be commercially useful in protecting our technology.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Patent
rights</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We own or have licensed from
BDD Pharma (as defined below) six patents and two patent applications in the United States and 92 patents and 17
patent applications in foreign countries and regions. In addition to the United States, we have patents issued or applications pending
in Australia, Brazil, Canada, China, Egypt, Europe (with pending applications before the European Patent Office and patents validated
with certain member states of the European Patent Organization), Hong Kong, Israel, India, Japan, Mexico, Russia, Saudi Arabia and South
Korea. The patents and patent applications describe and claim certain features of our product candidates, our PTR drug delivery platform
technology and our EBL, including claims to the product candidates, methods of making the product candidates and treatment methods using
the product candidates.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have and will continue to actively protect our intellectual property, including filing patent applications for our innovations, prosecuting
our pending patent applications, and maintaining and enforcing our issued patents. No assurances can be given that pending patent applications
will result in the issuance of a patent or that the examination process will not require us to narrow our claims. In addition, issued
patents may be circumvented by third parties, or found unenforceable or invalid if contested before a court or administrative agency.
Thus, we may not be able to successfully enforce our patent rights against third parties. No assurance can be given that others will
not independently develop a similar or competing technology or design around any patents that may be issued to us.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patent
life determination depends on the date of filing of the application and other factors as promulgated under the patent laws, such as patent
term adjustments and extensions. In most countries, including the United States, the patent term is generally 20 years from the earliest
claimed filing date of a non-provisional patent application in the applicable country. The patents and, if granted, patent applications
owned or licensed to us have expiry dates ranging from 2031 to 2036.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
owned and in-licensed patents and patent applications are summarized below.</FONT></P>

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    Application</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="border-bottom: black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; width: 15%; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Applicant/Owner</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Belgium, Brazil, Bulgaria,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Canada, Czech Republic, Denmark,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Finland, France,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Germany, Great Britain,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Greece, Hong Kong</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Hungary, India, Ireland,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Italy, Japan</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Mexico, Netherlands,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Norway, Poland,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Portugal, Romania,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Russia, Saudi Arabia</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">South Korea, Spain, Sweden,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Switzerland, Turkey,</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Hong Kong, India,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">Japan,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">South Korea, United States</P>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">WO2023/158694</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#8220;Trimodal,
    Precision-Timed Release Tablet&#8221;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CINGULATE
    THERAPEUTICS LLC</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">PCT
International</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Feb
    2043 (when issued)</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Trade
secret and other protection</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to patented intellectual property, we also rely on trade secrets and proprietary know-how to protect our technology and maintain
our competitive position, especially when we do not believe that patent protection is appropriate or can be obtained. Our policy is to
require each of our employees, consultants and advisors to execute a confidentiality and inventions assignment agreement before beginning
their employment, consulting or advisory relationship with us. The agreements generally provide that the individual must keep confidential
and not disclose to other parties any confidential information developed or learned by the individual during the course of the individual&#8217;s
relationship with us except in limited circumstances. These agreements generally also provide that we shall own all inventions conceived
by the individual in the course of rendering services to us.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Other
intellectual property rights</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
seek trademark protection in the United States when appropriate. We have filed for trademark protection for the Cingulate, Cingulate
Therapeutics trade dress and mark, which we use with our pharmaceutical research and development as well as products, as well as trade
names that could be used with our potential products. We currently have registered trademarks for Cingulate, Cingulate Therapeutics,
CTx and Mastery in the United States as well as for our PTR technology.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">From
time to time, we may find it necessary or prudent to obtain licenses from third party intellectual property holders.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Competition</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
industry has been exemplified by advancing technologies, intense competition, and a strong emphasis on proprietary products. We may face
competition from both pharmaceutical as well as generic drug companies as there are several short-acting and extended-release branded
products with various formulations, some quite innovative as well as generic versions of these that have yet to satisfy the unmet medical
need. We believe the key competitive factors that will affect the development and commercial success of our product candidates include
oral administration, therapeutic efficacy which includes immediate onset and entire active day duration, safety and tolerability profiles,
market access and pricing. Some competitors have substantially greater financial, technical and human resources than we do; however,
we believe the level of branded competition is diminishing and will continue to decline with the loss of exclusivity for Vyvanse. In
addition, our prospective competitors may also have more experience and expertise in obtaining marketing approvals from the FDA and foreign
regulatory authorities. In addition to product development, testing, approval and promotion, other competitive factors in the pharmaceutical
industry include consolidation, product quality and price, product technology, reputation, customer service and access to technical information.
As a result, our prospective competitors may be able to develop competing or superior products and compete more aggressively and sustain
their competitive advantage over a longer period of time than us. Our products may be rendered obsolete or may lack economic viability
in the face of competition.</FONT></P>

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approved, both CTx-1301 and CTx-1302 will compete against currently marketed, branded, and generic methylphenidate and amphetamine products
for the treatment of ADHD. Some of these currently available products include Janssen&#8217;s Concerta, Novartis&#8217; Focalin XR and
Takeda&#8217;s Adderall XR and Vyvanse, all which have lost exclusivity.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
recent years the ADHD market has seen the entrance of many innovative but niche-focused ADHD products that have not commanded the market
share of previous oral stimulants, in particular the extended-release oral stimulants. We are aware that we face competition from small
biotechnology companies focused in ADHD with niche products including Aytu, Tris, Corium, Ironshore, and Rhodes. However, we do not consider
most of these companies to be significant competitors as their products are only capable of capturing small subsets of the overall market
and do not employ substantial commercial efforts; whereas we believe our product candidates offer the potential to overcome longstanding
unmet needs for the majority of ADHD patients. In addition, Cingulate, along with a potential commercialization or strategic partner,
plans to employ appropriate resources to successfully commercialize its assets.</FONT></P>

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FDA recently issued revised guidance for bioequivalence testing of generic extended-release methylphenidate. This new guidance makes
it more difficult for new generic products to demonstrate bioequivalence to reference products. We believe this will limit generic competition
in the methylphenidate market. It may be difficult for a generic product to show bioequivalence to a new branded, extended- release dexmethylphenidate
drug with entire active day duration of effect, such as CTx-1301.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Government
Regulation</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Government
authorities in the United States at the federal, state and local levels and in other countries regulate, among other things, the research,
development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising,
distribution, post-approval monitoring and reporting, marketing and export and import of drug products. Generally, before a new drug
can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained, organized into a format specific
for each regulatory authority, submitted for review and ultimately approved by the applicable regulatory authority.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>U.S.
Drug Development</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In the United States, the FDA
regulates drugs under the FDCA and its implementing regulations. Drugs are also subject to other federal, state, and local statutes and
regulations. The process of obtaining regulatory approval and maintaining subsequent compliance with applicable federal, state and local
statutes and regulations requires the expenditure of substantial time, personnel, and financial resources. These agencies and other federal,
state and local entities regulate research and development activities and the testing, manufacture, quality control, labeling, storage,
packaging, recordkeeping, tracking, approval, import, export, distribution, advertising and promotion of pharmaceutical products. Failure
to comply with the applicable United States regulatory requirements at any time during product development, the approval process,
or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include, among other actions,
the FDA&#8217;s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters, voluntary
product recalls or market withdrawals, product seizures, total or partial suspension of production or distribution injunctions, fines,
consent decrees, refusals of government contracts, restitution, disgorgement, or civil and criminal penalties. Any agency or judicial
enforcement action could have a material adverse effect on us.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pharmaceutical
product candidates must be approved by the FDA through the NDA process before they may be legally marketed and sold in the United States.
Cingulate intends to submit our NDAs under the 505(b)(2) regulatory approval pathway. Development and approval of drugs generally involves
the following:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
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trials involving humans may begin;</FONT></TD></TR>
  </TABLE>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></P></TD>
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                                            other good clinical practices (&#8220;GCPs&#8221;) and other clinical-trial related
                                            regulations to evaluate the safety and efficacy of the investigational product for each proposed
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Submission
    of an NDA to the FDA for marketing approval, including payment of application user fees;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Satisfactory
    completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the drug is produced to assess compliance
    with cGMPs and assure that the facilities, methods and controls are adequate to preserve the drug&#8217;s identity, strength, quality
    and purity;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Possible
    FDA audit of the clinical trial sites to assure compliance with GCPs and the integrity of the clinical data submitted in support
    of the NDA; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">FDA
    review and approval of the NDA, including satisfactory completion of an FDA advisory committee review of the product candidate, where
    appropriate or if applicable, prior to any commercial marketing or sale of the product in the United States.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Preclinical
Studies</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Before
testing any drug product candidate in humans, it must undergo rigorous preclinical testing. The preclinical developmental stage generally
involves laboratory evaluations of drug chemistry, formulation and stability, as well as studies to evaluate toxicity in animals, which
support subsequent clinical testing. The sponsor must submit the results of the preclinical studies, together with manufacturing information,
analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. An IND is
a request for authorization from the FDA to administer an investigational product to humans, and must become effective before human clinical
trials may begin.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Preclinical
studies include laboratory evaluation of product candidate chemistry and formulation, as well as in vitro and animal studies, to assess
the potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is
subject to federal regulations and requirements, including GLP regulations for safety and toxicology studies. Some long-term preclinical
testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after an IND for an investigational drug
candidate is submitted to the FDA and human clinical trials have been initiated.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the case of testing data to support a 505(b)(2) NDA, some or all of the necessary preclinical data may be referenced in literature or
the FDA&#8217;s previous findings of safety and efficacy for an RLD.</FONT></P>

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Trials</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">All
clinical trials must be conducted under the supervision of qualified investigators. Clinical trials are conducted under protocols detailing
the objectives of the study, the parameters to be used in monitoring the safety and effectiveness criteria to be evaluated. Each protocol
must be submitted to the FDA as part of the IND. Study subjects must sign an informed consent form before participating in a clinical
trial. There are also requirements governing the reporting of on-going clinical trials and clinical trial results to public registries.
An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions
related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and
the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in
the FDA allowing clinical trials to commence. Clinical holds may also be imposed by the FDA at any time before or during studies due
to safety concerns or non-compliance.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, an IRB representing each institution that is participating in the clinical trial must review and approve the plan for any clinical
trial before it commences at that institution, and the IRB must thereafter conduct a continuing review and reapprove the trial at least
annually. The IRB must review and approve, among other things, the trial protocol and informed consent information to be provided to
clinical trial subjects. An IRB must operate in compliance with FDA regulations. Information about certain clinical trials, including
details of the protocol and eventually study results, also must be submitted within specific timeframes to the National Institutes of
Health for public dissemination on the ClinicalTrials.gov data registry. Information related to the product, patient population, phase
of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the registration of
the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure of the
results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Failure to timely
register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties and
also prevent the non-compliant party from receiving future grant funds from the federal government. The National Institutes of Health&#8217;s
(&#8220;NIH&#8221;) Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and both NIH
and FDA have signaled the government&#8217;s willingness to begin enforcing those requirements against non-compliant clinical trial sponsors.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Clinical
trials conducted to support an NDA are generally conducted in three sequential phases that may overlap or be combined.</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Phase
    1 - clinical trials generally involve a relatively small number of healthy volunteers who are initially exposed to a single dose
    or multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the safety, dosage tolerance,
    structure-activity relationships, mechanism of action, absorption, metabolism, distribution, and excretion in healthy volunteers
    or subjects with the target disease or condition. Changes to this general format that are suitable to a product candidate or a specific
    patient population may occur but usually are agreed to in advance with the FDA.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Phase
    2 - clinical trials typically involve studies in a limited patient population to identify possible adverse effects and safety risks,
    to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal
    dosage. </FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Phase
    3 - clinical trials are undertaken in larger subject populations to further evaluate dosage, clinical efficacy and safety in an expanded
    patient population, often at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit
    ratio of the product candidate and provide, if appropriate, an adequate basis for product labeling. These trials may include comparisons
    with placebo and/or other comparator treatments. The duration of treatment is often extended to mimic the actual use of a product
    during marketing. These trials may be done globally to support global registrations so long as the global sites are also representative
    of the United States population and the conduct of the study at global sites comports with FDA regulations and guidance, such
    as compliance with GCPs.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By
following the 505(b)(2) regulatory approval pathway, the applicant may reduce some of the burden of developing a drug by relying on investigations
not conducted by the applicant and for which the applicant has not obtained a right of reference, such as prior investigations involving
the RLD. In such cases, some clinical trials may not be required or may be otherwise limited; however, Phase 1 trials to establish bioavailability
and pharmacokinetic characteristics of the product candidate and at least one Phase 3 pivotal trial are usually required to support a
505(b)(2) NDA.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Post-approval
trials, sometimes referred to as Phase 4, may be conducted after initial marketing approval. These trials are used to gain additional
experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance
of Phase 4 clinical trials as a condition of approval of an NDA.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the development of a new drug product, sponsors have the opportunity to meet with the FDA at certain points, including prior to submission
of an IND, at the end of phase 2, and before submission of an NDA. These meetings can provide an opportunity for the sponsor to share
information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the
next phase of development. Sponsors typically meet with the agency before initiating Phase 3 clinical trials to present their plans for
the pivotal trial that they believe will support approval of the new drug product.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the physical
characteristics of the drug product and finalize a process for manufacturing the product in commercial quantities in accordance with
cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and,
among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug product.
Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product
candidate does not undergo unacceptable deterioration over its shelf life.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>NDA
and FDA Review Process</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Assuming
successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, along with detailed
descriptions of the product&#8217;s chemistry, manufacturing, and controls, proposed labeling and other relevant information are submitted
to the FDA as part of an NDA requesting approval to market the product. The cost of preparing and submitting an NDA is substantial. Under
federal law, the submission of most NDAs is additionally subject to a substantial application user fee, currently over $3.24 million
for an NDA with clinical information, and the manufacturer and/or sponsor under an approved NDA is also subject to an annual program
fee, currently approximately $394,000. These fees are typically increased annually. Fee waivers or reductions are available in certain
circumstances. One such fee waiver is available for applicants that are small businesses, meaning the applicant (including any affiliates)
employs fewer than 500 employees, does not have an approved marketing application for a product that has been introduced or delivered
for introduction into interstate commerce, and is submitting its first marketing application.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Section
505(b)(1) and Section 505(b)(2) of the FDCA are the provisions governing the type of NDAs that may be submitted under the FDCA. Section
505(b)(1) is the traditional pathway for new chemical entities when no other new drug containing the same active pharmaceutical ingredient
or active moiety, which is the molecule or ion responsible for the action of the drug substance, has been approved by the FDA. As an
alternate pathway to FDA approval for new or improved formulations of previously approved products, a company may file a Section 505(b)(2)
NDA. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies
not conducted by or for the applicant and for which the applicant has not obtained a right of reference.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Once
the FDA receives an application, it has 60 days to review the NDA to determine if it is substantially complete to permit a substantive
review, before it accepts the application for filing and may request additional information rather than accepting the applications. Once
the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the goals and policies agreed to by the FDA
under the Prescription Drug User Fee Act (PDUFA) VI, the agency seeks to review applications for standard review drug products within
10 months from the filing acceptance date, and applications for priority review drugs within six months from the filing acceptance date.
The FDA may grant a priority review designation to drugs that are intended to treat a serious condition and that the agency determines
offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA does not always meet its PDUFA goal
dates for standard and priority NDAs, and the review process for both standard and priority reviews may be extended by FDA for three
additional months to consider additional, late-submitted information, or information intended to clarify information already provided
in the submission in response to FDA review questions.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Before
approving an NDA, the FDA will typically conduct a pre-approval inspection of the manufacturing facilities for the product candidate
to determine whether they comply with cGMPs, unless the facility has recently had an FDA inspection. The FDA will not approve the product
unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure
consistent production of the product to specifications. Additionally, the FDA may refer applications for novel drug products or drug
products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians
and other experts, for review, evaluation and a recommendation regarding whether the application should be approved and, if so, under
what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers them carefully when making decisions.
NDAs submitted under Section 505(b)(2) are typically not referred to an Advisory Panel for consideration unless new safety information
is revealed in the review cycle.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
part of the NDA review process, the FDA likely will re-analyze the clinical trial data, which could result in extensive discussions between
the FDA and the applicant. Additionally, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs and
the IND protocol requirements and to assure the integrity of the clinical data submitted to the FDA. The review and evaluation of an
NDA by the FDA is extensive and time consuming and may take longer than originally planned to complete, and we may not receive a timely
approval, if at all.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">After
the FDA evaluates an NDA, it will issue either an approval letter or a complete response letter (&#8220;CRL&#8221;). An approval
letter authorizes the commercial marketing of the drug with prescribing information for specific indications. A CRL indicates that the
review cycle of the application is complete, and that the application will not be approved in its present form. A CRL generally describes
the deficiencies in the NDA identified by the FDA and may require substantial additional clinical data or other significant and time-consuming
requirements related to clinical trials, nonclinical studies or manufacturing. Additionally, the CRL may include recommended actions
that the applicant might take to place the application in a condition for approval. If a CRL is issued, the applicant may either resubmit
the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. If, or when, those deficiencies have
been addressed to the FDA&#8217;s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter to the applicant.
The FDA has committed to reviewing such resubmissions in response to an issued CRL in either two or six months depending on the type
of information included. Even with the submission of this additional information, however, the FDA may decide that the NDA does not satisfy
the regulatory criteria for approval. Data obtained from clinical trials are not always conclusive, and the FDA may interpret data differently
than the sponsor interprets the same data.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
is no assurance that the FDA will approve a product candidate for marketing, and the sponsor may encounter significant difficulties or
costs during the review process. Even if a product receives marketing approval, the approval may be significantly limited to specific
diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further,
the FDA may require that certain contraindications, warnings or precautions be included in the product labeling, or it may condition
approval on changes to the proposed labeling. The FDA also may condition approval on the development of adequate controls and specifications
for manufacturing and a commitment to conduct post-marketing testing and surveillance to monitor the potential effects and efficacy.
For example, the FDA may require Phase 4 trials designed to further assess a drug&#8217;s safety and efficacy.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA may also place restrictions and conditions on product distribution, prescribing, or dispensing in the form of a REMS plan in addition
to the approved labeling, to help ensure that the benefits of the drug outweigh its risks. A REMS could include medication guides for
patients, communication plans for health care professionals, and/or elements to assure safe use (&#8220;ETASU&#8221;). ETASU can
include, but are not limited to, special training or certification for prescribing or dispensing, restricted distribution requirements,
dispensing only under certain circumstances, special monitoring, and the use of patient registries. The FDA determines the requirement
for a REMS, as well as the specific REMS provisions, on a case-by-case basis. If the FDA concludes a REMS plan is needed, the sponsor
of the NDA must submit a proposed REMS plan. The FDA will not approve the NDA without an approved REMS, if required. Based on the required
warnings included in the approved labeling of drug products containing the same drug substance as our product candidates (dexmethylphenidate
and dextroamphetamine), we expect that as part of the NDA review and approval process, FDA will require at least some of our product
candidates, in particular CTx-1301 and CTx-1302, to include black box warnings as part of their labeling.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
of the above-mentioned limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing
of products and therefore limit commercial success. Marketing approval may be withdrawn for non-compliance with regulatory requirements
or if problems occur following initial marketing.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">After
NDA approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling
claims, are subject to further testing requirements, FDA notification, and FDA review and approval. Further, should new safety information
arise, additional testing, product labeling or FDA notification may be required.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Hatch-Waxman
Act and New Drug Marketing Exclusivity</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments to the FDCA, Congress
authorized the FDA to approve generic drugs that are the same as drugs previously approved by the FDA under the NDA provisions of the
statute and also enacted Section 505(b)(2) of the FDCA. To obtain approval of a generic drug, an applicant must submit an ANDA,
to the agency. In support of such applications, a generic manufacturer may rely on the preclinical and clinical testing conducted for
a drug product previously approved under an NDA, known as the RLD. Specifically, in order for an ANDA to be approved, the FDA must find
that the generic version is identical to the RLD with respect to the active ingredients, the route of administration, the dosage form,
and the strength of the drug. In contrast, Section 505(b)(2) permits the filing of an NDA where at least some of the information required
for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance
on studies conducted for a previously-approved product is scientifically appropriate. Unlike the ANDA pathway used by developers of bioequivalent
versions of innovator drugs, which does not allow applicants to submit new clinical data other than bioavailability or bioequivalence
data, the 505(b)(2) regulatory pathway does not preclude the possibility that a follow-on applicant would need to conduct additional
clinical trials or nonclinical studies; for example, they may be seeking approval to market a previously approved drug for new indications
or for a new patient population that would require new clinical data to demonstrate safety or effectiveness. The FDA may then approve
the new product for all or some of the label indications for which the RLD has been approved, or for any new indication sought by the
Section 505(b)(2) applicant, as applicable.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
seeking approval of an NDA or a supplement thereto, the NDA sponsor is required to list with the FDA each patent with claims that cover
the sponsor&#8217;s product or an approved method of using the product. Upon approval of an NDA, each of the patents listed in the application
for the drug is published in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the
Orange Book. When an ANDA applicant submits its application to the FDA, the applicant is required to certify to the FDA concerning any
patents listed in the Orange Book for the RLD, except for patents covering methods of use for which the follow-on applicant is not seeking
approval. To the extent a Section 505(b)(2) applicant is relying on studies conducted for an already approved product, such an applicant
is also required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that
an ANDA applicant would.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Specifically,
any applicant who subsequently files an ANDA or 505(b)(2) NDA that references the drug listed in the Orange Book must certify to the
FDA that with respect to each published patent, (i) the required patent information has not been filed by the original applicant of the
RLD; (ii) the listed patent already has expired; (iii) the listed patent has not expired, but will expire on a specified date and approval
is sought after patent expiration; or (iv) the listed patent is invalid, unenforceable or will not be infringed by the manufacture, use
or sale of the new product. These are known as Paragraph I, II, III, and IV certifications, respectively.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a Paragraph I or II certification is filed, the FDA may make approval of the application effective immediately upon completion of its
review. If a Paragraph III certification is filed, the approval may be made effective on the patent expiration date specified in the
application, although a tentative approval may be issued before that time. If an application contains a Paragraph IV certification, a
series of events will be triggered, the outcome of which will determine the effective date of approval of the ANDA or 505(b)(2) application.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
certification that the new product will not infringe the RLD&#8217;s listed patents or that such patents are invalid is called a Paragraph
IV certification. If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice
of the Paragraph IV certification to the NDA and patent holders for the RLD once the applicant&#8217;s NDA has been accepted for filing
by the FDA. The NDA and patent holders may then initiate a legal challenge to the Paragraph IV certification. The filing of a patent
infringement lawsuit within 45 days of their receipt of a Paragraph IV certification automatically prevents the FDA from approving the
ANDA or 505(b)(2) NDA until the earlier of 30 months after the receipt of the Paragraph IV notice, expiration of the patent or a decision
in the infringement case that is favorable to the ANDA or 505(b)(2) applicant. Alternatively, if the listed patent holder does not file
a patent infringement lawsuit within the required 45-day period, the follow-on applicant&#8217;s ANDA or 505(b)(2) NDA will not be subject
to the 30-month stay.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, under the Hatch-Waxman Amendments, the FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent
exclusivity for the referenced RLD has expired. These market exclusivity provisions under the FDCA also can delay the submission or the
approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to
the first applicant to gain approval of a NDA for a drug containing a new chemical entity. A drug is a new chemical entity if the FDA
has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action
of the drug substance. During the exclusivity period, the FDA may not accept for review an ANDA or a 505(b)(2) NDA submitted by another
company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required
for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDCA also provides three years of marketing exclusivity for a NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations,
other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval
of the application, for example, new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the
conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving follow-on applications
for drugs containing the original active agent. Five-year and three-year exclusivity also will not delay the submission or approval of
a traditional NDA filed under Section 505(b)(1) of the FDCA. However, an applicant submitting a traditional NDA would be required to
either conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary
to demonstrate safety and effectiveness.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Patent
Term Extension</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">After
NDA approval, owners of relevant drug patents may apply for up to a five-year patent term extension. The allowable patent term extension
is calculated as half of the drug&#8217;s testing phase &#8211; the time between when the IND becomes effective and NDA submission &#8211;
and all of the review phase &#8211; the time between NDA submission and approval, up to a maximum of five years. The time can be shortened
if FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed
14 years. For patents that might expire during the application phase, the patent owner may request an interim patent extension. An interim
patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension granted,
the post-approval patent extension is reduced by one year. The director of the Patent and Trademark Office (PTO) must determine that
approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not
available for a drug for which an NDA has not been submitted.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Pediatric
Clinical Trials and Exclusivity</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Under
the Pediatric Research Equity Act (&#8220;PREA&#8221;), an NDA or certain types of supplements to an NDA must contain data to
assess the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing
and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission
of pediatric data or full or partial waivers.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
purposes of satisfying the requirements of PREA, the appropriate age ranges to be studied may vary, depending on the pharmacology of
the drug or biological product, the manifestations of the disease in various age groups, and the ability to measure the response to therapy.
PREA requires pediatric assessments to be gathered &#8220;using appropriate formulations for each age group for which the assessment
is required&#8221; (section 505B(a)(2)(A) of the Act). Under PREA, applicants must submit requests for approval of the pediatric formulation
used in their pediatric studies, and failure to submit such a request may render the product misbranded (section 505B(d) of the Act).
FDA interprets the language &#8220;request for approval of a pediatric formulation&#8221; to mean that applicants must submit an application
or supplemental application for any not previously approved formulation(s) used to conduct their pediatric studies.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Food and Drug Administration Safety and Innovation Act, which was signed into law on July 9, 2012, amended the FDCA to require that a
sponsor who is planning to submit an NDA for a new active ingredient, new indication, new dosage form, new dosing regimen or new route
of administration submit an initial Pediatric Study Plan (&#8220;iPSP&#8221;) within 60 days of an end-of-Phase 2 meeting or,
if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 trial. The initial PSP must include
an outline of the pediatric trial(s) that the sponsor plans to conduct, including objectives and design, age groups, relevant endpoints
and statistical approach, or a justification for not including such information, and any request for a deferral of pediatric assessments
or a full or partial waiver of the requirement to provide data from pediatric trials along with supporting information. The FDA and the
sponsor must reach an agreement on the PSP, but the sponsor can submit amendments to an agreed-upon initial PSP at any time if changes
to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and other
clinical development programs. We have submitted our iPSP, and it was accepted. We continue to be in discussions with the FDA regarding
our PREA obligations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Best Pharmaceuticals for Children Act provides NDA holders a six-month extension of any exclusivity &#8211; patent or non-patent &#8211;
for a drug if certain conditions are met, including satisfaction of a pediatric trial(s) agreed with FDA as a Pediatric Written Request.
Conditions for pediatric exclusivity include the FDA&#8217;s determination that information relating to the use of a new drug in the
pediatric population may produce health benefits in that population, the FDA making a written request for pediatric clinical trials,
and the applicant agreeing to perform, and reporting on, the requested clinical trials within the statutory timeframe. This six-month
exclusivity may be granted if an NDA sponsor submits pediatric data that fairly respond to the written request from the FDA for such
data. Those data do not need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is
deemed to fairly respond to the FDA&#8217;s request, the additional protection is granted. Although this is not a patent term extension,
it effectively extends the regulatory period during which the FDA cannot approve another application.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Disclosure
of Clinical Trial Information</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Sponsors
of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information on the website
www.clinicaltrials.gov. Information related to the product, patient population, phase of investigation, trial sites and investigators,
and other aspects of a clinical trial are then made public as part of the registration. Sponsors are also obligated to disclose the results
of their clinical trials after completion. Disclosure of the results of clinical trials can be delayed in certain circumstances for up
to two years after the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding
the progress of clinical development programs as well as clinical trial design.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Post-Approval
Requirements</I></B></FONT></P>

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approval of a drug product, the manufacturer and the approved drug product are subject to pervasive and continuing regulation by the
FDA, including, among other things, monitoring and record-keeping activities, reporting of adverse experiences with the product, product
sampling and distribution restrictions, complying with promotion and advertising requirements, which include restrictions on promoting
drugs for unapproved uses or patient populations (i.e., &#8220;off-label use&#8221;) and limitations on industry-sponsored scientific
and educational activities. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market
or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses,
and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including adverse publicity,
enforcement action by the FDA, corrective advertising, consent decrees and the full range of civil and criminal penalties available to
the FDA. Prescription drug promotional materials also must be submitted to the FDA in conjunction with their first use. Further, if there
are any modifications to the approved drug product, including changes in indications, labeling or manufacturing processes or facilities,
the applicant may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the applicant to develop
additional data or conduct additional preclinical studies or clinical trials.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">FDA
regulations require that products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations
include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product
containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls,
records and reports and returned or salvaged products. The manufacturing facilities for our product candidates must meet cGMP requirements
and satisfy the FDA or comparable foreign regulatory authorities&#8217; satisfaction before any product is approved and our commercial
products can be manufactured. These manufacturers must comply with cGMPs that require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with
the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance
with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production
and quality control to maintain compliance with cGMPs. The discovery of violative conditions, including failure to conform to cGMPs,
could result in enforcement actions including cessation of manufacturing activities. The discovery of problems with a product after approval
may result in restrictions on a product, manufacturer or holder of an approved NDA, including recalls and product seizures.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented, or FDA notification.
If there are any modifications to the drug, including changes to indications, labeling, or manufacturing processes or facilities, the
applicant may be required to submit and obtain FDA approval of a supplemental NDA or new NDA, which may require the applicant to develop
additional data or conduct additional pharmaceutical development/formulation studies, nonclinical studies or clinical trials.</FONT></P>

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an approval of a prescription drug is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards
is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product,
including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory
requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market or
clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential
consequences include, among other things:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify; text-indent: -0.25in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify; text-indent: -0.25in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, the distribution of prescription pharmaceutical products, including samples, is subject to the Prescription Drug Marketing
Act (&#8220;PDMA&#8221;), which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards
for the registration and regulation of drug distributors by the states. Both the PDMA and state laws regulate the distribution of prescription
pharmaceutical product samples and impose requirements to ensure accountability in distribution.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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the Drug Supply Chain Security Act (&#8220;DSCSA&#8221;) was enacted in 2013 with the aim of building an electronic system to
identify and trace certain prescription drugs distributed in the United States. The DSCSA mandates phased-in and resource-intensive obligations
for pharmaceutical manufacturers, wholesale distributors, and dispensers over a 10-year period that is expected to culminate in November
2023. From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of prescription drug products regulated by the FDA. It is impossible to predict whether
further legislative or regulatory changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact
of such changes, if any, may be.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>DEA
Regulation</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
active ingredients in our current drug product candidates are listed by the DEA as controlled substances under the CSA. The CSA
and its implementing regulations establish a closed chain of distribution for entities handling controlled substances and impose registration,
record-keeping and reporting, security, storage, procurement, manufacturing, distribution, importation, exportation, labeling, packaging,
and other requirements on such entities. The DEA requires individuals or entities that handle controlled substances to comply with these
requirements to ensure legitimate use and prevent diversion of controlled substances to illicit channels of commerce.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
CSA categorizes controlled substances into one of five schedules, Schedule I, II, III, IV or V, depending on the potential for abuse
and physical or psychological dependence. Schedule I substances by definition have a high potential for abuse, have no currently accepted
medical use in treatment in the United States and lack accepted safety for use under medical supervision. They may not be marketed
or sold for dispensing to patients in the United States Pharmaceutical products having a currently accepted medical use and that
are otherwise approved for marketing may be listed as Schedule II, III, IV, or V substances, with Schedule II substances presenting the
highest potential for abuse and physical or psychological dependence, and Schedule V substances presenting the lowest relative potential
for abuse and dependence. Schedule II substances (as well as substances defined as narcotics in any Schedule) are subject to the strictest
requirements for registration, security, recordkeeping and reporting, and the distribution and dispensing of these substances are highly
regulated. For example, all Schedule II drug prescriptions must be signed by a physician, physically presented to a pharmacist in most
situations, unless they are electronically prescribed pursuant to DEA regulations, and may not be refilled. The active ingredients in
our product candidates (dexmethylphenidate and dextroamphetamine) are Schedule II controlled substances and are under various restrictions.
Consequently, the procurement, manufacturing, shipping, storage, sales and use of the products, if approved, will be subject to a high
degree of regulation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Facilities
that manufacture, distribute, import or export controlled substances must register annually with the DEA. The registration is specific
to the particular location, activity and controlled substance schedule. For example, separate registrations are needed for import and
manufacturing, and each registration will specify which schedules of controlled substances are authorized. Similarly, separate registrations
are also required for separate facilities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
DEA inspects manufacturers, distributors, importers, and exporters to review compliance with the CSA and DEA regulations, including security,
record keeping and reporting prior to issuing a controlled substance registration and on a periodic basis. The specific security requirements
vary by the type of business activity and the schedule and quantity of controlled substances handled by the registrant, with the most
stringent requirements applying to Schedule I and Schedule II substances. Required security measures include background checks on employees
and physical control of inventory through measures such as vaults and inventory reconciliations. Manufacturers and distributors must
also submit regular reports to the DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances,
and other designated substances. Records must be maintained for the handling of all controlled substances, for example, a complete and
accurate record of each substance manufactured, received, sold, delivered, or otherwise disposed of. All DEA registrants must also report
any controlled substance thefts or significant losses and must obtain authorization to destroy or dispose of controlled substances. In
addition to maintaining an importer and/or exporter registration, importers and exporters of controlled substances must obtain a permit
for every import or export of a Schedule I or II substance and a narcotic substance in Schedule III, IV and V. For all other drugs in
Schedule III, IV and V, importers and exporters must submit an import or export declaration.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, a DEA quota system controls and limits the availability and production of controlled substances in Schedule I or II. The DEA
establishes annually an aggregate quota for how much of a controlled substance may be produced in total in the United States based on
the DEA&#8217;s estimate of the quantity needed to meet legitimate scientific and medicinal needs. The limited aggregate number of opioids
and stimulants that the DEA allows to be produced in the United States each year is allocated among individual companies, which must
submit applications annually to the DEA for individual production and procurement quotas. We must receive an annual quota from the DEA
in order to produce or procure our Schedule II substance for use in manufacturing of our product and product candidates. The DEA may
adjust aggregate production quotas and individual production and procurement quotas from time to time during the year, although the DEA
has substantial discretion in whether or not to make such adjustments. Distributions of any Schedule I or II controlled substance must
also be accompanied by special order forms, with copies provided to the DEA.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Failure
to maintain compliance with applicable DEA requirements, particularly as manifested in loss or diversion or controlled substances, can
result in administrative, civil or criminal enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations,
or initiate administrative proceedings to revoke those registrations. In some circumstances, violations could lead to criminal prosecution.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
various states and the District of Columbia also regulate controlled substances and impose similar licensing, recordkeeping, and reporting
requirements on entities that handle controlled substances. Entities must independently comply with the various state requirements in
addition to the federal controlled substance requirements.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Pharmaceutical
Coverage, Pricing and Reimbursement</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Significant
uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may obtain regulatory approval.
In the United States, sales of pharmaceutical products depend in significant part on the availability of coverage and adequate reimbursement
by third-party payors, such as state and federal governmental authorities, including those that administer the Medicare and Medicaid
programs, managed care organizations and private insurers. Decisions regarding the extent of coverage and amount of reimbursement to
be provided for each of our product candidates will be made on a plan-by-plan basis. The Medicare and Medicaid programs are often used
as models by private payors and other governmental payors to develop their coverage and reimbursement policies for drugs. However, one
payor&#8217;s determination to provide coverage for a product does not assure that other payors will also provide coverage, and adequate
reimbursement, for the product. Each third-party payor determines whether or not it will provide coverage for a drug, what amount it
will pay providers for the drug, and on what tier of its formulary the drug will be placed. These decisions are influenced by the existence
of multiple drug products within a therapeutic class and the net cost to the plan, including the amount of the prescription price, if
any, rebated by the drug&#8217;s manufacturer. Typically, generic versions of drugs are placed in a preferred tier. The position of a
drug on the formulary generally determines the co-payment that a patient will need to make to obtain the drug and can strongly influence
the adoption of a drug by patients and physicians. Patients who are prescribed treatments for their conditions and providers performing
the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are
unlikely to use our products unless coverage is provided, and reimbursement is adequate to cover a significant portion of the cost of
our products. Additionally, a third-party payor&#8217;s decision to provide coverage for a drug does not imply that an adequate reimbursement
rate will be approved. Also, third-party payors are developing increasingly sophisticated methods of controlling healthcare costs. As
a result, coverage, reimbursement and placement determinations are complex and are often the subject of extensive negotiations between
the payor and the owner of the drug.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unless
we enter into a strategic collaboration under which our collaborator assumes responsibility for seeking coverage and reimbursement for
a given product, we will be responsible for negotiating coverage, reimbursement and placement decisions for our product candidates. Coverage,
reimbursements and placement decisions for a new product are based on many factors including the coverage, reimbursement and placement
of already marketed branded drugs for the same or similar indications, the safety and efficacy of the new product, availability of generics
for similar indications, the clinical need for the new product and the cost-effectiveness of the product.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Within
the Medicare program, CTx-1301, CTx-1302 and CTx-2103, which, if approved would likely be self-administered drugs, would likely be reimbursed
under the expanded prescription drug benefit known as Medicare Part D. This program is a voluntary Medicare benefit administered by private
plans that operate under contracts with the federal government. These plans develop formularies that determine which products are covered
and what co-pay will apply to covered drugs. The plans have considerable discretion in establishing formularies and tiered co-pay structures,
negotiating rebates with manufacturers and placing prior authorization and other restrictions on the utilization of specific products,
subject to review by CMS for discriminatory practices. These Part D plans negotiate discounts with drug manufacturers, which are
passed on, in whole or in part, to each of the plan&#8217;s enrollees through reduced premiums.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with, as applicable, the Medicare Prescription
Drug Improvement and Modernization Act of 2003 as well as the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of
1990 (&#8220;OBRA&#8221;) and the Veterans Health Care Act of 1992, each as amended. Among other things, the OBRA requires drug
manufacturers to pay rebates on prescription drugs to state Medicaid programs and empowers states to negotiate rebates on pharmaceutical
prices, which may result in prices for our future products that will likely be lower than the prices we might otherwise obtain. If products
are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements
apply.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Third-party
payors, including the United States government, continue to apply downward pressure on the reimbursement of pharmaceutical products.
For example, the Inflation Reduction Act of 2022 reduces the US government reimbursement for some drugs. Also, the trend towards managed
health care in the United States and the concurrent growth of organizations such as health maintenance organizations may result in lower
reimbursement for pharmaceutical products. We expect that these trends will continue as these payors implement various proposals or regulatory
policies. There are currently, and we expect that there will continue to be, a number of federal and state proposals to implement controls
on reimbursement and pricing, directly and indirectly.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Other
Healthcare Laws and Compliance Requirements</B></FONT></P>

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we are commercializing our product candidates, if they are approved by the FDA or comparable foreign regulatory agencies for marketing,
we will be subject to additional healthcare statutory and regulatory requirements and enforcement by federal government and the states
and foreign governments in the jurisdictions in which we conduct our business. Healthcare providers, physicians and third-party payors
will play a primary role in the recommendation and prescription of any other product candidates for which we obtain marketing approval.
Our arrangements with third-party payors and customers expose us to broadly applicable fraud and abuse and other healthcare laws and
regulations that constrain the business or financial arrangements and relationships through which we market, sell and distribute any
products for which we obtain marketing approval.</FONT></P>

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under applicable federal and state healthcare laws and regulations include the following:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal Anti-Kickback Statute prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving
    or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the
    purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare
    and Medicaid programs. The federal Anti-Kickback Statute is subject to evolving interpretations. In the past, the government has
    enforced the federal Anti-Kickback Statute to reach large settlements with healthcare companies based on sham consulting and other
    financial arrangements with physicians. A person or entity does not need to have actual knowledge of the statute or specific intent
    to violate it in order to have committed a violation. In addition, the government may assert that a claim including items or services
    resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil
    False Claims Act;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    federal civil and criminal false claims laws, including the civil False Claims Act, and civil monetary penalty laws, prohibit, among
    other things, knowingly presenting or causing the presentation of a false, fictitious or fraudulent claim for payment to the United
    States government, knowingly making, using, or causing to be made or used a false record or statement material to a false or
    fraudulent claim to the United States government, or from knowingly making a false statement to avoid, decrease or conceal
    an obligation to pay money to the United States government. Actions under these laws may be brought by the Attorney General
    or as a qui tam action by a private individual in the name of the government. The federal government uses these laws, and the accompanying
    threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the
    United States, for example, in connection with the promotion of products for unapproved uses and other allegedly unlawful
    sales and marketing practices;</FONT></TD></TR>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including
private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a
criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making
any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items
or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or
specific intent to violate it in order to have committed a violation;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The PPACA, among other things, imposes reporting requirements on manufacturers
of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare, Medicaid, or the Children&#8217;s Health Insurance
Program to report, on an annual basis, to CMS information related to payments and other transfers of value to physicians (defined to include
doctors, dentists, optometrists, podiatrists, chiropractors and, beginning in 2022 for payments and other transfers of value provided
in the previous year, certain advanced non-physician health care practitioners), teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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impose specified requirements relating to the privacy, security and transmission of individually identifiable health information. Among
other things, HITECH makes HIPAA&#8217;s privacy and security standards directly applicable to &#8220;business associates,&#8221; defined
as independent contractors or agents of covered entities, which include certain healthcare providers, health plans, and healthcare clearinghouses,
that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered
entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly
other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce
HIPAA and seek attorneys&#8217; fees and costs associated with pursuing federal civil actions;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    state and foreign laws and regulations, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements
    and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">State
    laws that require pharmaceutical companies to comply with the pharmaceutical industry&#8217;s voluntary compliance guidelines and
    the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures to the extent that
    those laws impose requirements that are more stringent than the Physician Payments Sunshine Act, as well as state and local laws
    that require the registration of pharmaceutical sales representatives; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">State
    laws and foreign laws and regulations (particularly European Union laws regarding personal data relating to individuals based in
    Europe) that govern the privacy and security of health information in certain circumstances, many of which differ from each other
    in significant ways, thus complicating compliance efforts.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify; text-indent: -0.25in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In November 2020, the
United States Department of Health and Human Services (&#8220;DHHS&#8221;) finalized significant changes to the regulations
implementing the Anti-Kickback Statute, with the goal of offering the healthcare industry more flexibility and reducing the
regulatory burden associated with those fraud and abuse laws, particularly with respect to value-based arrangements among industry
participants.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Ensuring
that our current and future business arrangements with third parties comply with applicable healthcare laws and regulations involves
substantial costs. It is possible that governmental authorities may conclude that our business practices may not comply with current
or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may
be subject to significant civil, criminal and administrative penalties, including monetary damages, fines, disgorgement, imprisonment,
loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement
or other government programs, including Medicare and Medicaid, reputational harm, diminished profits and future earnings, or additional
reporting requirements if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance
with any of these laws, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers
or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal,
civil or administrative sanctions, including exclusions from government funded healthcare programs.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Healthcare
Reform and Potential Changes to Healthcare Laws</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change
the healthcare system in ways that could affect our ability to sell our future products profitably. Among policy makers and payors in
the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing
healthcare costs, improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus
of these efforts and has been significantly affected by major legislative initiatives. The FDA&#8217;s and other regulatory authorities&#8217;
policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our
product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies,
or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we
may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.
Moreover, among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare
systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By
way of example, PPACA was enacted in March 2010 and has had a significant impact on the health care industry in the United States. PPACA
expanded coverage for the uninsured while at the same time containing overall healthcare costs. With regard to biopharmaceutical products,
PPACA, among other things, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program
are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care
organizations, established annual fees on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage
gap discount program.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">As another example, the 2021 Consolidated
Appropriations Act signed into law on December 27, 2020, incorporated extensive healthcare provisions and amendments to existing laws,
including a requirement that all manufacturers of drugs and biological products covered under Medicare Part B report the product&#8217;s
average sales price to the DHHS beginning on January 1, 2022, subject to enforcement via civil money penalties.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In addition, other legislative
changes have been proposed and adopted in the United States since the PPACA that affect health care expenditures. These changes include
aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which
began in 2013 and will remain in effect through 2030 unless additional Congressional action is taken. The Coronavirus Aid, Relief, and
Economic Security Act, (the &#8220;CARES Act&#8221;), which was signed into law on March 27, 2020 and was designed to provide
financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester
from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030, in order to offset the added expense
of the 2020 cancellation. The 2021 Consolidated Appropriations Act was subsequently signed into law on December 27, 2020 and extended
the CARES Act suspension period to March 31, 2021. The most recently enacted pandemic-relief legislation, the American Rescue Plan Act
of 2021, which was signed into law on March 11, 2021, also includes significant healthcare system reforms and programs intended to strengthen
the insurance marketplace established under the PPACA, among others. In addition, other legislative changes that affect the pharmaceutical
industry have been proposed and adopted in the United States since the ACA was enacted. For example, the Inflation Reduction Act of 2022
included, among other things, a provision that authorizes CMS to negotiate a &#8220;maximum fair price&#8221; for a limited number of
high-cost, single-source drugs every year, and another provision that requires drug companies to pay rebates to Medicare if prices rise
faster than inflation.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which
has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,
bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for drug products. DHHS has solicited feedback on some of various measures intended to lower drug
prices and reduce the out of pocket costs of drugs and implemented others under its existing authority. For example, in May 2019, DHHS
issued a final rule to allow Medicare Advantage plans the option to use step therapy for Part B drugs beginning January 1, 2020. This
final rule codified a DHHS policy change that was effective January 1, 2019. Congress and the executive branch have each indicated that
it will continue to seek new legislative and/or administrative measures to control drug costs, making this area subject to ongoing uncertainty.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Individual
states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical
product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing
cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
In December 2020, the United States Supreme Court held unanimously that federal law does not preempt the states&#8217; ability
to regulate pharmaceutical benefit managers (&#8220;PBMs&#8221;) and other members of the health care and pharmaceutical supply
chain, an important decision that may lead to further and more aggressive efforts by states in this area.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA&#8217;s and other regulatory authorities&#8217; policies also may change and additional government regulations may be enacted that
could prevent, limit or delay regulatory approval of our drug candidates. For example, in December 2016, the 21st Century Cures Act (the
&#8220;Cures Act&#8221;) was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs
and devices and to spur innovation, but its ultimate implementation is uncertain. In addition, in August 2017, the FDA Reauthorization
Act was signed into law, which reauthorized the FDA&#8217;s user fee programs and included additional drug and device provisions that
build on the Cures Act. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or
policies, we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and
results of operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and lower reimbursement, and in additional downward pressure on the price that we receive for any approved product. Any reduction
in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain
profitability or commercialize our drugs, once regulatory approval is obtained. We cannot predict the likelihood, nature or extent of
government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.
We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts
that federal and state governments will pay for healthcare products and services, including any future pharmaceutical products for which
we secure marketing approval.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Data
Privacy and the Protection of Personal Information</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are regulated by laws and regulations governing data privacy, security, and the protection of personal information, including health
information, that are applicable to our business and associated data processing activities. The legislative and regulatory landscape
for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues globally
which will continue to affect our business. In the United States, we may be subject to state data breach notification laws, state
laws protecting the privacy and security of health and personal information and federal and state consumer protections laws which regulate
the collection, use, disclosure and transmission of personal information. These laws may overlap and conflict with each other, and each
of these laws is subject to varying interpretations by courts and government agencies, creating complex compliance issues for us. If
we fail to comply with applicable data protection laws and regulations we could be subject to penalties or sanctions, including criminal
penalties. Our current and future customers and research partners must comply with laws governing the privacy and security of health
information, including HIPAA and state health information privacy laws. If we knowingly obtain health information that is protected under
HIPAA, called &#8220;protected health information,&#8221; without observing the correct protocols which may include execution of a business
associate agreement, implementation of privacy or security measures, and other obligations, our customers or research collaborators may
be subject to enforcement actions, and we may have direct liability for the unlawful receipt of protected health information or for aiding
and abetting a HIPAA violation.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in">State laws
protecting health and personal information are becoming increasingly stringent. For example, California has implemented the
California Confidentiality of Medical Information Act, which imposes restrictive requirements regulating the use and disclosure of
health information and other personally identifiable information. Washington has enacted the My Health My Data Act, which will
(with certain exceptions) become effective on March 31, 2024, and Nevada&#8217;s Consumer Health Privacy Law will enter into force
on March 31, 2024. The development of general state privacy laws has been even more rapid. In 2020 California implemented the
California Consumer Privacy Act of 2018 (&#8220;CCPA&#8221;). The CCPA reflects several key concepts included in the European
Union General Data Protection Regulation (&#8220;GDPR&#8221;). The CCPA establishes a new privacy framework for covered
businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the
State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially
severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security
procedures and practices to prevent data breaches. On January 1, 2023, the California Privacy Rights Act (&#8220;CPRA&#8221;)
entered into force and significantly modified the CCPA. This may result in further uncertainty, additional costs and expenses in an
effort to comply, as well as additional potential for harm and liability for failure to comply. In addition to California, twelve
other states have enacted state data privacy laws, and in five of these states &#8211; Colorado, Connecticut, Nevada, Utah and
Virginia &#8211; these laws have entered into force in 2023. Other states in the U.S. are considering privacy laws similar to
CCPA/CPRA and other state privacy laws.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">When we do business and/or conduct
clinical trials in the UK or the EEA (i.e., the EU plus Liechtenstein, Norway and Iceland), we are subject to the GDPR as well
as the GDPR as saved into United Kingdom law by virtue of section 3 of the United Kingdom&#8217;s European Union (Withdrawal) Act 2018
and the UK&#8217;s Data Protection Act 2018 (&#8220;DPA 2018&#8221;) (the &#8220;UK GDPR&#8221;). The GDPR and UK GDPR apply to business
colleagues, employees, service providers, trial participants and other individuals like investigators or CRO employees who are residents
of the UK or EEA. Violations of the UK GDPR and/or the GDPR can carry hefty fines of up to EUR 20 million / &#163;17.5 million or 4%
of the total annual worldwide revenue in the preceding financial year, whichever is higher.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>U.S. Foreign Corrupt Practices Act</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">In general, the Foreign Corrupt
Practices Act of 1977, as amended, or the FCPA, prohibits offering to pay, paying, promising to pay, or authorizing the payment of money
or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity
or to secure any other improper advantage in order to obtain or retain business for or with, or in order to direct business to, any person.
The prohibitions apply not only to payments made to &#8220;any foreign official,&#8221; but also those made to &#8220;any foreign political
party or official thereof,&#8221; to &#8220;any candidate for foreign political office&#8221; or to any person, while knowing that all
or a portion of the payment will be offered, given, or promised to anyone in any of the foregoing categories. &#8220;Foreign officials&#8221;
under the FCPA include officers or employees of a department, agency, or instrumentality of a foreign government. The term &#8220;instrumentality&#8221;
is broad and can include state-owned or state-controlled entities. Importantly, United States authorities deem most healthcare professionals
and other employees of foreign hospitals, clinics, research facilities and medical schools in countries with public healthcare and/or
public education systems to be &#8220;foreign officials&#8221; under the FCPA. When we interact with foreign healthcare professionals
and researchers in testing and marketing our products abroad, should any of our product candidates receive foreign regulatory approval
in the future, we must have policies and procedures in place sufficient to prevent us and agents acting on our behalf from providing any
bribe, gift or gratuity, including excessive or lavish meals, travel or entertainment in connection with marketing our products and services
or securing required permits and approvals. The FCPA also obligates companies whose securities are listed in the United States to comply
with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation,
including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international
operations.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Material
Agreements</B></FONT></P>

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Commercialization Agreement with Indegene, Inc.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; background-color: white">On
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">March 7, 2023<FONT STYLE="background-color: white">,
we entered into the Joint Commercialization Agreement </FONT>Indegene<FONT STYLE="background-color: white">. </FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
<FONT STYLE="background-color: white">Commercialization </FONT>Agreement governs the general terms under which Indegene will provide
commercialization services for CTx-1301, if we receive FDA approval for CTx-1301, upon our request. Pursuant to the <FONT STYLE="background-color: white">Commercialization
</FONT>Agreement, the parties will enter into statements of work that will set forth, among other things, the services to be performed
by Indegene, the deliverables for such services, and the fees to be paid by us. Each statement of work will be governed by the terms
of the <FONT STYLE="background-color: white">Commercialization </FONT>Agreement, unless expressly modified in such statement of work.
We may elect to receive the following services from Indegene: (a) medical affairs &amp; pharmacovigilance; (b) pricing, reimbursement
and market access; (c) commercial operations; and (d) marketing (including field force). The parties will negotiate in good faith any
changes to the services provided by Indegene due to changes in circumstances or priorities established by us.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
<FONT STYLE="background-color: white">Commercialization </FONT>Agreement will expire three years after the launch of CTx-1301. We may
terminate the Commercialization Agreement upon six (6) months prior written notice to Indegene, and Indegene may terminate the Commercialization
Agreement upon twelve (12) months prior written notice to us. In addition, either party may terminate the <FONT STYLE="background-color: white">Commercialization
</FONT>Agreement upon thirty (30) days prior, written notice if: (i) the FDA notifies us that it will not approve our NDA for CTx-1301;
or (ii) we suspend or terminate our clinical development program for CTx-1301 in the United States. Either party may terminate the <FONT STYLE="background-color: white">Commercialization
</FONT>Agreement upon thirty (30) days prior, written notice for material, uncured breaches or immediately in the event of the other
party&#8217;s bankruptcy.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the term of the <FONT STYLE="background-color: white">Commercialization Agreement</FONT>, except for medical information services, the
development and publication of peer-reviewed articles and pharmacovigilance services, Indegene will not provide strategic health care
provider and/or patient marketing support (or any other types of services that are in the same category) to any party except us with
respect to any ADHD product. Until the date of any notice of termination of the <FONT STYLE="background-color: white">Commercialization
</FONT>Agreement or any notice of termination of a given service, we will not engage a party other than Indegene to provide any services
with respect to commercialization of CTx-1301 that are in the same category as any of the services being provided to us by Indegene without
Indegene&#8217;s written approval, not to be unreasonably withheld, subject to certain exceptions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 43.7pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
<FONT STYLE="background-color: white">Commercialization </FONT>Agreement contains representations, warranties, confidentiality and indemnity
obligations customary for agreements of this type.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Master
Services Agreement with Societal CDMO, Inc.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Effective
October 24, 2022, we entered into a master services agreement with Societal (the &#8220;Manufacturing Agreement&#8221;). <FONT STYLE="background-color: white">The
Manufacturing Agreement governs the general terms under which Societal, or one of its affiliates, will provide manufacturing services
as specified by us at Societal&#8217;s Gainesville, Georgia manufacturing facility.</FONT> Such services are performed under agreed statements
of work. Under the terms of the Manufacturing Agreement, we have agreed to pay fees for Societal&#8217;s performance of services as provided
in each applicable statement of work.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Manufacturing Agreement terminates in October 2027 <FONT STYLE="background-color: white">or such later date as required to complete a
statement of work (the &#8220;</FONT>Initial Term<FONT STYLE="background-color: white">&#8221;) and will renew automatically thereafter
for successive twelve (12) month periods (a &#8220;</FONT>Renewal Term<FONT STYLE="background-color: white">&#8221;) unless terminated
by either party at least twelve (12) months (if prior to the successful completion of process validation batches for the first product)
or twenty-four (24) months (after successful completion of validation batches for the first product) prior to the end of the Initial
Term or any Renewal Term</FONT>. The term of each statement of work terminates upon completion of the services under such statement of
work, unless terminated earlier. We may terminate the Manufacturing Agreement or any statement of work upon ninety (90) days prior, written
notice to Societal. <FONT STYLE="background-color: white">Societal may terminate a statement of work due to certain delays or inactivity
or if the services provided under such statement of work cannot be performed in accordance with applicable regulatory requirements; provided,
that Societal shall use commercially reasonable efforts to engage in meaningful discussions with us prior to any such termination. Societal
may terminate the Agreement upon six (6) months prior, written notice if all statements of work have been terminated.</FONT> The Manufacturing
Agreement or a statement of work may be terminated by either party for material, uncured breaches or in the event of the other party&#8217;s
bankruptcy.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Manufacturing Agreement includes customary terms relating to, among others, indemnification, intellectual property protection, confidentiality,
remedies and warranties.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Patent
and Know-How License Agreement with BDD Pharma Limited</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
entered into a patent and know-how license agreement with BDD Pharma Limited (&#8220;BDD Pharma&#8221;) in August 2018, which we refer
to as the BDD Pharma License Agreement. Pursuant to the BDD Pharma License Agreement, we have an exclusive license under technology,
patents and know-how owned or controlled by BDD Pharma and relating to a barrier layer for controlled drug release in order to develop,
manufacture, market, use, import, sell or otherwise supply and commercialize products that (i) deliver three distinct doses of dextroamphetamine,
dexmethylphenidate or any methylphenidate based or any amphetamine based drug, (ii) have an extended release in vitro over a period of
more than eight hours or (iii) are otherwise covered by the patents or are made, developed or used in accordance with the know-how. We
also have the right to apply for marketing approvals and carry out clinical trials for the purpose of obtaining marketing approvals of
such products. The rights granted to us are worldwide and exclusive in the field of the treatment of any disease or disorder in humans
amenable to treatment with a methylphenidate-based or amphetamine-based drug or mixture or combination thereof. We have the right to
sublicense the rights granted to us, subject to certain conditions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">BDD
Pharma was entitled to a payment of $198,625 in connection with execution of the BDD Pharma License Agreement. We may be required to
pay BDD Pharma aggregate milestone payments of $750,000 ($250,00 of which has already been paid) for each product in connection
with clinical trial and regulatory milestones, with different dose strengths of a product being considered the same product for purposes
of milestone payments. We may be required to pay BDD Pharma low to mid-single digit royalties on aggregate net sales of products. We
may also be required to pay BDD Pharma low to mid-single digit royalties on aggregate net receipts of products based on sales made by
our sublicensees and non-royalty sublicensing consideration that we receive.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unless
terminated earlier, the term of the BDD Pharma License Agreement continues until the later of the expiration of the last-to-expire of
all the patents licensed to us or the last-to-expire of all of our payment obligations. Our royalty payment obligations expire on a product-by-product
and country-by-country basis upon the later of 10 years from the first commercial sale of a product in a country or expiration of the
last-to-expire patent covering the manufacture, use or sale of the product in a country. Currently, the last-to expire patent licensed
from BDD Pharma expires in November of 2035. Upon expiration of our royalty payment obligations, the licenses granted to us become fully-paid,
irrevocable and perpetual.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We,
or BDD Pharma, may terminate the BDD Pharma License Agreement if there is an uncured material breach by the other party or in connection
with the other party&#8217;s insolvency. BDD Pharma may terminate the BDD Pharma License Agreement immediately upon written notice if
we, any sublicensee or related party or affiliate directly challenges, or assists a third party in challenging, the validity or enforcement
of the patents owned by BDD Biopharma or the secret nature of the know-how.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Human
Capital Resources</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
achieve our goals, it is crucial that we attract and retain talented employees. To facilitate this, we strive to maintain a safe and
rewarding workplace, with opportunities for our employees to grow and develop in their careers, supported by competitive pay, comprehensive
benefits and health and wellness programs, and programs that build connections among our employees. Our compensation program includes
the granting of stock options to attract, retain, and incentivize employees.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">As of December 31, 2023, we employed
thirteen (13) employees. Of these, six (6) are engaged in research and development and manufacturing activities, and seven
(7) in general and administrative functions. All of our employees are located in the United States. We utilize outside consultants
and independent contractors to supplement our full-time workforce. None of our employees are represented by a labor organization or are
under a collective-bargaining arrangement. We consider our employee relations to be good.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Corporate
Information</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is a Delaware corporation that was formed in May 2021 to serve as a holding company. CTx is a Delaware limited liability
company that was formed in November 2012. In connection with the consummation of our IPO, on September 29, 2021, Cingulate Inc. acquired
CTx through the merger of a wholly-owned acquisition subsidiary of Cingulate Inc. with and into CTx (the &#8220;Reorganization Merger&#8221;).
As a result of the Reorganization Merger, CTx became a wholly-owned subsidiary of Cingulate Inc. Unless otherwise stated or the context
otherwise requires, all information in this prospectus reflects the consummation of the Reorganization Merger and the IPO.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
primary executive offices are located at 1901 West 47<SUP>th</SUP> Place, Kansas City, Kansas 66205 and our telephone number is (913)
942-2300. Our website address is <I>www.cingulate.com</I>. The information contained in, or accessible through, our website does not
constitute a part of this prospectus. We have included our website address in this annual report solely as an inactive textual reference.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Properties</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
corporate headquarters is located in Kansas City, Kansas, where we lease approximately 14,205 square feet of office space. Our lease
expires in May 2025, with an option to extend. Our manufacturing activities take place at Societal, our CDMO in Gainesville, Georgia.
We believe our current offices, laboratories, and manufacturing spaces are sufficient to meet our needs. We may seek to negotiate new
leases or evaluate additional or alternate space to accommodate operations. We believe that appropriate alternative space is readily
available on commercially reasonable terms.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>Legal Proceedings</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We are not a party to any material pending legal proceedings. From time
to time, we may be subject to legal proceedings and claims arising in the ordinary course of business.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="di_004"></FONT>MANAGEMENT&#8217;S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated
financial statements and related notes included elsewhere in this prospectus. Some of the information contained in this discussion and
analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties. You should review the &#8220;Risk Factors&#8221; section of this prospectus
for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by
the forward-looking statements contained in the following discussion and analysis.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Overview</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
are a biopharmaceutical company using our proprietary Precision Timed Release<SUP>TM</SUP> (&#8220;PTR<SUP>TM</SUP>&#8221;) drug
delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives
of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment
outcomes. We are initially focusing our efforts on the treatment of ADHD. Our PTR platform
incorporates a proprietary Erosion Barrier Layer (&#8220;EBL&#8221;) designed to allow for the release of drug substance at specific,
pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets. We believe there remains a significant, unmet
need within the current treatment paradigm for true once-daily ADHD stimulant medications with lasting duration and a superior side effect
profile to better serve the needs of patients throughout their entire active-day.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Since
inception in 2012, our operations have focused on developing our product candidates, organizing and staffing our company, business planning,
raising capital, establishing our intellectual property portfolio and conducting clinical trials. We do not have any product candidates
approved for sale and have not generated any revenue. We have funded our operations through public and private capital raised. Cumulative
capital raised from these sources, including debt financing, was approximately $79.0 million as of September 30, 2023.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have incurred significant losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will
depend on the successful development and commercialization of one or more of our product candidates. Our net losses were $6.0 million
and $4.0 million for the three-month periods ended September 30, 2023 and 2022, respectively, and $16.6 million and $13.1 million for
the nine-month periods ended September 30, 2023 and 2022, respectively. See &#8220;Results of Operations&#8221; below for an explanation
of the fluctuations in our net losses. As of September 30, 2023, we had an accumulated deficit of $86.0 million.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect to continue to incur significant expenses and increasing operating losses in the near term. We expect our expenses will increase
substantially in connection with our ongoing activities, as we:</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">continue
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">manufacture
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">outsource
    commercial infrastructure to support sales and marketing for CTx-1301; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">operate
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of September 30, 2023, we had cash and cash equivalents of $2.0 million. We believe that the net proceeds from this offering,
together with our cash on hand, will satisfy our capital needs through late second quarter of 2024 under our current business
plan. In addition, in order to achieve the filing of our NDA for CTx-1301 in the first half of 2025 for potential FDA approval, we believe
that we will need approximately $8-10 million of additional capital. We will also need additional capital to advance our
other programs and commercialization efforts. See &#8220;Liquidity and Capital Resources&#8221; below.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of
one or more of our product candidates. Until such time as we can generate significant revenue from product sales, if ever, we expect
to finance our operations through the sale of equity, debt financings, or other capital sources, including potential collaborations with
other companies or other strategic transactions. Adequate funding may not be available to us on acceptable terms, or at all. If we fail
to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the
development and commercialization of our product candidates.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Clinical,
Manufacturing and Business Update</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CTx-1301:
</B>A Phase 3 adult dose-optimization study to assess the efficacy and safety, along with onset and duration, of CTx-1301 in adults
with ADHD was initiated in December 2022 and completed in June 2023. Results were presented at the 2023 Psych Congress and will be presented
at the 2024 American Professional Society of ADHD and Related Disorders (&#8220;APSARD&#8221;) in January 2024. This Phase 3 CTx-1301study
(NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD
in an adult laboratory classroom setting. It did not achieve statistical significance on the primary efficacy endpoint but CTx-1301 demonstrated
a trend toward significance in improving Permanent Product Measure of Performance (&#8220;PERMP&#8221;) scores compared to placebo. Clinical
Global Impression Scale (&#8220;CGI-S&#8221;) scores with CTx-1301 compared to placebo also showed significant improvements that were
indeed statistically significant for this secondary endpoint. The treatment effect size of CTx-1301 in this trial was notable &#8211;
starting at 30 minutes and demonstrated the ability of CTx-1301 to improve upon ADHD symptoms in patients over an entire active day.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, we initiated two CTx-1301 Phase 3 clinical studies in pediatric and adolescent patients- a fixed dose study (NCT05286762) and
a dose-optimized onset and duration study in a laboratory classroom setting (NCT05924594) &#8211; in the third quarter of 2023. Based
on guidance received from the FDA regarding our clinical program for CTx-1301, we stopped enrollment in these two studies. All enrolled
patients in these studies can complete the study and data will be reported accordingly. Additionally, based on this guidance, we expect
to submit the NDA for CTx-1301 in the first half of 2025 under the Section 505(b)(2) pathway with Focalin&#174; XR as the reference listed
drug, using its efficacy and safety data on file with the FDA as a basis for approval, together with bioavailability/bioequivalence data
and efficacy/safety data from our CTx-1301 clinical program. If we receive FDA approval for CTx-1301, we may conduct Phase 4 trials.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
plan to initiate the clinical plan for CTx-1302 (dextroamphetamine), our second investigational asset for the treatment of ADHD, as soon
as 2025, pending additional capital resources.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Societal,
a</FONT> CDMO dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic
development, will manufacture all clinical, registration, and commercial batches of our lead ADHD candidate, CTx-1301. In April 2023,
we successfully completed the transfer of our proprietary PTR&#8482; manufacturing processes for our lead candidate, CTx-1301 (dexmethylphenidate),
to Societal, which has produced a scalable supply of CTx-1301 for our Phase 3 trials in the manufacturing suite within Societal&#8217;s
Gainesville, GA facility that is outfitted with equipment supplied by us.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
March 2023, we announced a joint commercialization agreement with Indegene, a comprehensive life sciences commercialization company,
to provide commercial support for our lead candidate CTx-1301 (dexmethylphenidate). The agreement spans cross-functional services through
an omnichannel marketing approach uniquely designed to successfully manage pre-commercial support during our Phase 3 clinical trials
and to effectively commercialize CTx-1301 nationwide following potential FDA approval.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CTx-2103:
</B>We have embarked on a program to develop CTx-2103 (buspirone) for the treatment of anxiety, which is one of the most common mental
health concern in the United States. We completed a formulation study in which the pharmacokinetics were evaluated for this trimodal
tablet providing three precisely timed doses of buspirone versus one immediate release dose. In addition, scintigraphic imaging visualized
transit of the tablets through the gastrointestinal tract to confirm both the site and onset of release, which will then be correlated
with pharmacokinetic data to establish the full release profile of the CTx-2103 formulation. Based on the pharmacokinetic profile seen
in the data, CTx-2103 achieved a triple release of buspirone. These results provided the critical information required to allow us to
request a Pre-IND meeting with the FDA to discuss the design of our clinical and regulatory program for CTx-2103 which occurred in
the fourth quarter of 2023. We received input from the FDA regarding the regulatory pathway for CTx-2103, and the design of clinical
studies for filing of an IND. Based on this FDA feedback, we believe that we can seek and win approval of CTx-2103 under the 505(b)(2)
pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway.</FONT></P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CTx-1302:
</B>We plan to initiate the clinical plan for CTx-1302 (dextroamphetamine), our second investigational asset for the treatment of
ADHD, as soon as 2025, pending additional capital resources.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>PTR<SUP>TM
</SUP>Platform:</B> We continue to evaluate opportunities to out-license our PTR platform and to license our product candidates outside
of the United States In addition, we are evaluating opportunities to expand our relationship with BDD Pharma Limited.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Securities
Issuances</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>ATM
Agreement</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
entered into an At The Market Offering Agreement (&#8220;ATM Agreement&#8221;) with H.C. Wainwright &amp; Co., LLC (&#8220;HCW&#8221;),
as sales agent, in January 2023 as amended in May 2023, pursuant to which we may offer and sell, from time to time through HCW, shares
of our common stock for aggregate proceeds of up to $4.97 million (upon the terms and subject to the conditions and limitations set forth
in the ATM Agreement). During the three months ended September 30, 2023, we sold 76,943 shares of common stock pursuant to the ATM Agreement,
for net proceeds of $1,595,429 after deducting $49,502 of compensation to HCW and other administration fees. During the nine months ended
September 30, 2023, we sold 82,410 shares of common stock pursuant to the ATM Agreement, for net proceeds of $1,696,407 after deducting
$59,898 of compensation to HCW and other administration fees. Subsequent to September 30, 2023, we sold 283,300 shares of common stock
pursuant to the ATM Agreement, for net proceeds of $3,115,303 after deducting $97,512 of compensation to HCW and other administration
fees</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Equity
Line of Credit</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
April 2023, we entered into a purchase agreement (&#8220;Lincoln Park Agreement&#8221;) with Lincoln Park Capital Fund LLC (&#8220;Lincoln
Park&#8221;). Pursuant to the Lincoln Park Agreement, Lincoln Park has agreed to purchase from us up to an aggregate of $12.0 million
of common stock (upon the terms and subject to the conditions and limitations set forth in the Lincoln Park Agreement) from time to time
and at our sole discretion over the 36-month term of the Lincoln Park Agreement. During the three months ended September 30, 2023, we
sold 12,000 shares of common stock pursuant to the Lincoln Park Agreement, for net proceeds of $196,167. During the nine months ended
September 30, 2023, we sold 25,500 shares of common stock pursuant to the Lincoln Park Agreement, for net proceeds of $450,427. Subsequent
to September 30, 2023, we did not sell any shares of common stock pursuant to the Lincoln Park Agreement.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Private
Placement</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 11, 2023, we entered into a Securities Purchase Agreement with WFIA (the &#8220;August 2023 Purchase Agreement&#8221;)
and issued, in a private placement priced at the market under the Nasdaq Stock Market&#8217;s rules, 91,158 shares of
our common stock at a purchase price per share of $10.97, resulting in gross proceeds to us of approximately $1.0 million (the
&#8220;WFIA Private Placement&#8221;).</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Debt
Conversion</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">In
August 2022, CTx, a wholly-owned subsidiary of Cingulate Inc. issued the Original Note to WFIA with a principal amount
of $5.0 million (the &#8220;Original Principal Amount&#8221;), and in May 2023, CTx issued an Amended and Restated Promissory
Note (the &#8220;WFIA Note&#8221;) increasing the principal amount under the Original Note by $3.0 million to $8.0 million (the
&#8220;2023 WFIA Debt Financing&#8221;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">On
September 8, 2023, Cingulate Inc. and CTx entered into a note conversion agreement with WFIA, pursuant to which WFIA agreed to
convert the Original Principal Amount under the WFIA Note plus all accrued interest thereon, or $5,812,500, into pre-funded warrants
(the &#8220;September WFIA Pre-Funded Warrants&#8221;) to purchase 341,912 shares of our common stock at a conversion price per
September WFIA Pre-Funded Warrant of $17.00. The closing price of our common stock on Nasdaq on September 8, 2023 was $11.55 per
share. The September WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of
$0.002 per share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially own, for purposes
of Section 13(d) of the Exchange Act, no more than 19.99% of the outstanding shares of our common stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">On
January 25, 2024, Cingulate Inc. and CTx entered into a Note Conversion Agreement (the &#8220;January 2024 Note Conversion Agreement&#8221;)
with WFIA, pursuant to which WFIA agreed to convert the remaining $3.0 million of principal under the WFIA Note plus all accrued interest
thereon, or $3,287,500, into pre-funded warrants (the &#8220;January WFIA Pre-Funded Warrants&#8221;) to purchase 687,043 shares of our
common stock, at a conversion price per January WFIA Pre-Funded Warrant of $4.785. The closing price of the Common Stock on Nasdaq on
January 24, 2024 was $4.35 per share. The January WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at
an exercise price of $0.0001 per share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially
own, for purposes of Section 13(d) of the Exchange Act, no more than 19.99% of the outstanding shares of our common stock.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">The
WFIA Note was unsecured with interest accruing at 15% per annum. Outstanding principal and all accrued and unpaid interest was
due and payable on August 8, 2025 unless accelerated due to an event of default. WFIA had the right during the first five
business days of each calendar quarter to demand payment of all outstanding principal and interest 120 days following notice to us. We
were permitted prepay the WFIA Note, in whole or in part, without premium or penalty; provided, that no amount repaid was permitted
to be reborrowed. As of September 30, 2023, there was $3.0 million of principal and accrued interest on the WFIA Note was $0.2 million.
After the conversion of the remaining principal amount plus all accrued interest thereon and the issuance of the January WFIA Pre-Funded
Warrants, the WFIA Note was paid in full and the Company has no further obligations under the WFIA Note. See &#8220;Liquidity and
Capital Resources&#8221; below.</P>

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Offering</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 11, 2023, we entered into a Securities Purchase Agreement with an institutional investor, pursuant to which we issued 86,000
shares of our common stock, pre-funded warrants to purchase up to an aggregate of 260,260 shares of our common stock, Series A warrants
to purchase up to 346,260 shares of our common stock and Series B warrants to purchase up to 173,130 shares of our common stock (the
&#8220;September 2023 Offering&#8221;). The September 2023 Offering closed on September 13, 2023. The combined purchase price
per share of common stock and accompanying Series A and Series B warrants was $11.55 The combined purchase price per pre-funded warrant
and accompanying Series A and Series B warrants was $11.55, which represents the public offering price per share of common stock and
accompanying warrants less the $0.002  per share exercise price for each pre-funded warrant. The pre-funded warrants are exercisable
at any time after the date of issuance and have no expiration date. The holder of pre-funded warrants may not exercise the warrants if
the holder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of the number
of shares of common stock outstanding immediately after giving effect to such exercise. The Series A warrants have an exercise price
of $11.55 per share, are exercisable beginning on November 3, 2023, the effective date of stockholder approval of the issuance of the
shares issuable upon exercise of the warrants, and will expire five years after the initial exercise date, and the Series B warrants
have an exercise price of $11.55 per share, are exercisable beginning on November 3, 2023, the effective date of stockholder approval
of the issuance of the shares issuable upon exercise of the warrants and will expire two years after the initial exercise date. We received
gross proceeds of approximately $4.0 million, before deducing the placement agent&#8217;s fees and other offering expenses, pursuant
to the September 2023 Offering.</FONT></P>

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of Operating Results</B></FONT></P>

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inception, we have not generated any revenue and do not expect to generate any revenue from the sale of products in the near future.
If our development efforts for our product candidates are successful and result in regulatory approval, or if we enter into collaboration
or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from
collaboration of license agreements.</FONT></P>

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Expenses</I></B></FONT></P>

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and Development Expenses</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Research
and development expenses consist of costs incurred in the discovery and development of our product candidates, and primarily include:</FONT></P>

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sites, that conducted or will conduct our clinical trials and a portion of our pre-clinical activities;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expense all research and development costs as incurred, other than manufacturing equipment used in research and development which is
capitalized and amortized over its estimated useful life. Costs for external development activities are recognized based on an evaluation
of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based
on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated
financial statements as prepaid or accrued costs.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Research
and development activities are central to our business model. We expect that our research and development expenses will continue to increase
for the foreseeable future as we continue clinical development for our product candidates. As products enter later stages of clinical
development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to
the increased size and duration of later-stage clinical trials. Historically, our research and development costs have primarily related
to the development of CTx-1301. As we advance CTx-1301, CTx-1302, and CTx-2103, as well as identify any other potential product candidates,
we will continue to allocate our direct external research and development costs to the products. We expect to fund our research and development
expenses from our current cash and cash equivalents and any future equity or debt financings, or other capital sources.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>General
and Administrative Expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">General
and administrative expenses consist primarily of salaries and related costs for our employees in administrative, executive and finance
functions. General and administrative expenses also include professional fees for legal, accounting, audit, tax and consulting services,
insurance, office, and travel expenses.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect that our general and administrative expenses will increase in the future as we increase our general and administrative headcount
to support our growing operations including the potential commercialization of our product candidates. We have experienced increased
expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax compliance services;
director and officer insurance; and investor and public relations costs.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Interest
and other income (expense), net</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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and other income (expense), net consists of interest expense on our related party notes payable and interest earned on our cash and cash
equivalents, including money market funds. The primary objective of our investment policy is liquidity and capital preservation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Critical
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0pt; text-align: justify; text-indent: 0.5in; background-color: white">Our
consolidated financial statements are prepared in accordance with the United States generally accepted accounting principles (&#8220;U.S.
GAAP&#8221;). The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of
the date of the consolidated financial statements and the reported amounts of expenses during a reporting period. Actual results could
differ from estimates.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"></P>

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our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements, we believe the following
accounting policies are those most critical to the judgements and estimates used in the preparation of our consolidated financial statements.</FONT></P>

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and development costs are expensed as incurred and include all direct and indirect costs associated with the development of our product
candidates. These expenses include payments to third parties for research, development and manufacturing services, personnel costs and
depreciation on manufacturing equipment. At the end of the reporting period, we compare payments made to third party service providers
to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional
information becomes available. Depending on the timing of payments to service providers and the progress that we estimate have been made
as a result of the service provided, we may record net prepaid or accrued expense relating to these costs.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Stock-Based Compensation</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">Under
the 2021 Plan, we granted non-qualified stock options to certain employees and directors in 2022 and 2021. The options were
granted with strike prices ranging from $20.00 to $31.40 per share in 2022 and $120.00 per share in 2021, which was the price that the
common shares were issued to the public in connection with our IPO. The term of these options is ten years with vesting periods ranging
from immediate to four years.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">We
recorded stock-based compensation expense of $800,796 and $43,835 during the years ended December 31, 2022 and 2021, respectively, based
on the grant-date fair value of the options granted. The fair value of each option grant was estimated as of the date of grant using the
Black-Scholes option-pricing model. The fair value is amortized as compensation cost on a straight-line basis over the requisite service
period of the awards, which is generally the vesting period.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">See
footnote 11 to our consolidated financial statements for the assumptions that were used to estimate the fair value of stock options granted
using the Black-Scholes option pricing model.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white"><B>Results of Operations</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><B><I>Comparison of the three
months ended September 30, 2023 and September 30, 2022:</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">The
following table summarizes our results of operations for the three months ended September 30, 2023 and September 30, 2022:</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Operating
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Research
and development expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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following table summarizes our research and development (&#8220;R&amp;D&#8221;) expenses for the three months ended September
30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Clinical
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">860</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">R&amp;D
expenses were $3.9 million for the three months ended September 30, 2023, an increase of $1.8 million, or 84.8%, from the three months
ended September 30, 2022. This change was primarily the result of increased clinical activity as compared to the same period in 2022.
During the third quarter of 2023, we initiated two Phase 3 studies for CTx-1301, the pediatric dose optimization onset and duration study
and the fixed dose pediatric and adolescent safety and efficacy study. In addition, the Phase 3 adult dose-optimization study for CTx-1301
was completed in June 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>General
and administrative expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our general and administrative (&#8220;G&amp;A&#8221;) expenses for the three months ended September
30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Insurance</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">398</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">669</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(271</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">101</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">99</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2.0</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)%</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    general and administrative expenses</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,845</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(19</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1.0</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)%</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
G&amp;A expenses for the three months ended September 30, 2023 were flat compared to the three months ended September 30, 2022, primarily
the result of a decrease in insurance costs, which was related to a decline in the annual directors&#8217; and officers&#8217; insurance
policy premium that was renewed in December of 2022, offset by an increase in legal fees relating to capital raise activities during
the third quarter of 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Interest
and other income (expense), net</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes interest and other income (expense), net for the three months ended September 30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Interest
    and other income (expense):</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Three
    Months ended</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">September
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Increase</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Increase</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(in
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    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2022</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Decrease)</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(Decrease)</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Interest
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(229</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(59</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(171</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(289.8</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)%</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
interest and other income (expense), net in the three months ended September 30, 2023 primarily related to interest on the $8.0 million
of principal under the WFIA Note, of which $5.0 million of principal was converted to equity in early September 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
interest and other income (expense), net in the three months ended September 30, 2022 primarily related to interest on the initial $5.0
million of principal under the WFIA Note, dated August 2022, offset by interest earned during the period.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Comparison
of the nine months ended September 30, 2023 and September 30, 2022:</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our results of operations for the nine months ended September 30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Operating
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Research
and development expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our R&amp;D expenses for the nine months ended September 30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Nine
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Clinical
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Drug
    manufacturing and formulation</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">3,254</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2,827</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">427</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">15.1</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Personnel
    expenses</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">1,902</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2,097</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Regulatory
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    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">281</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">58</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">223</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">R&amp;D
expenses were $10.5 million for the nine months ended September 30, 2023, an increase of $3.4 million, or 48.8%, from the nine months
ended September 30, 2022. The increase was primarily the result of a significant increase in clinical activity as compared to the same
period in 2022. We initiated the Phase 3 adult dose-optimization study for CTx-1301 in late 2022 and completed it in June 2023. Additionally,
we incurred expenses in connection with the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study and the Phase
3 pediatric dose-optimization onset and duration study, both for CTx-1301, which were initiated during the third quarter of 2023. Manufacturing
activity also increased in 2023, as we completed the manufacturing of clinical supply for the CTx-1301 Phase 3 studies.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>General
and administrative expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our G&amp;A expenses for the nine months ended September 30, 2023 and September
30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(5</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1.3</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)%</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    general and administrative expenses</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
G&amp;A expenses were $5.4 million for the nine months ended September 30, 2023, a decrease of $0.5 million, or 8.5%, from the nine months
ended September 30, 2022. This change was primarily the result of a decrease in insurance costs of $0.8 million related to a decline
in the annual directors&#8217; and officers&#8217; insurance policy premium that was renewed in December of 2022, offset by an increase
in personnel expenses resulting from the addition of clinical personnel and annual compensation increases.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Interest
and other income (expense), net</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes interest and other income (expense), net for the nine months ended September 30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    30,</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Interest
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(638</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(44</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
interest and other income (expense), net in the nine months ended September 30, 2023 primarily related to interest on the initial $5.0
million of principal under the WFIA Note, dated August 2022, which was subsequently increased to $8.0 million in May 2023, and decreased
by $5.0 million due to a conversion to equity in early September 2023, offset by interest earned on invested balances.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
interest and other income (expense), net in the nine months ended September 30, 2022 primarily related to interest on the initial $5.0
million of principal under the WFIA Note, dated August 2022, offset by interest earned during the period.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Comparison
of the years ended December 31, 2022 and December 31, 2021</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our results of operations for the years ended December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Research
and development expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our research and development expenses for the years ended December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">R&amp;D
expenses were $9.0 million for the year ended December 31, 2022, an increase of $0.6 million or 7.0% from the year ended December
31, 2021. This increase was related to a significant increase in clinical and manufacturing costs for CTx-1301 as we completed a food
effect study in the fourth quarter of 2022 and initiated the Phase 3 adult dose-optimization study in late 2022. In addition, our manufacturing
costs increased in 2022 relating to the production of clinical supply for Phase 3 trials of CTx-1301. These increases were offset by
a decrease in personnel expenses due to the recording of $4.6 million to R&amp;D expense in 2021 for a one-time noncash compensation
charge for the modification of PIUs. The decrease in personnel expenses due to the one-time noncash charge was offset by annual pay increases
in 2022 and added personnel in late 2021 in anticipation of increased clinical activity.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>General
and administrative expenses</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes our G&amp;A expenses for the years ended December 31, 2022
and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">288</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
G&amp;A expenses were $8.5 million for the year ended December 31, 2022, a decrease of $3.8 million or 30.7% from the year ended December
31, 2021. Personnel expenses decreased $7.1 million or 73.4%, primarily related to the recording of $8.1 million to G&amp;A personnel
expenses of a one-time noncash compensation charge in 2021 relating to the modification of profits interests units (&#8220;PIUs&#8221;).
This decrease in personnel expenses due to the noncash compensation charge was offset by an increase in salaries expense due to the
addition of personnel in late 2021 as we were preparing to operate as a public company. The decrease in personnel expenses was offset
by increases in other expenses, including legal fees and audit fees primarily due to increased activity in late 2022 in preparation for
future capital raises. In addition, insurance costs increased significantly year-over-year due to the directors and officers insurance
premium which is much higher for a publicly traded company.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Interest
and other income (expense), net</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes interest and other income (expense), net for the years ended December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Year
    ended</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">December
    31,</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Increase</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(in
    thousands)</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2022</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Interest
    and other income (expense), net</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(174</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(31</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">143</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">461.3</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">%</FONT></TD></TR>
  </TABLE>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
interest and other income (expense), net in both 2022 and 2021 primarily relates to interest incurred on outstanding notes payable, offset
by interest earned on invested balances. Interest expense was significantly higher in 2022 due to $0.3 million of interest incurred on
the $5.0 million related party note payable to WFIA, dated August 2022.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Cash
Flows</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="6" STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Nine
Months ended September 30,</B></FONT></P></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2023</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2022</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 60%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
    cash (used in) operating activities</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(12,472</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(11,676</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
    cash (used in) investing activities</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(37</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(10</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
    cash provided by financing activities</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">9,139</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">4,989</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
    decrease in cash and cash equivalents</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3,370</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(6,697</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Operating Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in operating activities was $12.5 million for the nine months ended September 30, 2023. Cash used in operating activities was
primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $16.6 million, prior
to the effects of two noncash items, stock-based compensation expense of $0.7 million and depreciation expense of $0.4 million. Changes
in operating assets and liabilities included a decrease in miscellaneous receivables of $0.2 million primarily due to collection of an
amount recoverable on an insurance claim which had been recorded as a receivable as of December 31, 2022, a decrease of prepaid expenses
and other current assets of $1.4 million primarily due to the utilization of deposits made to our CMO and contract research organizations,
an increase in trade accounts payable and accrued expenses of $1.5 million due to increased clinical and manufacturing expenses resulting
from increased development activity, an increase in interest accrued for to the WFIA Note, and an increase in legal fees payable relating
to legal activity incurred primarily in connection with capital raise activities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in operating activities was $11.7 million for the nine months ended September 30, 2022. Cash used in operating activities was
primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $12.8 million, prior
to the effects of two noncash items, stock-based compensation expense of $0.6 million and depreciation of $0.3 million. Changes in operating
assets and liabilities included a decrease in miscellaneous receivables resulting from the receipt in early 2022 of a significant portion
of the payroll and research and development tax credits owed to us, and an increase in prepaid expenses and other current assets relating
to prepaid amounts on clinical development activity.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Investing Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in investing activities for both the nine-month periods ended September 30, 2023 and September 30, 2022 was related to the
purchase of equipment to support our research and development.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Financing Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash provided by financing activities for the nine months ended September 30, 2023 was primarily related to gross proceeds of approximately
$4.0 million from the September 2023 Offering, gross proceeds of approximately $1.0 million from the WFIA Private Placement and proceeds
from the issuance of shares of common stock pursuant to the Lincoln Park Agreement and the ATM Agreement. In addition, we received $3.0
million from the 2023 WFIA Debt Financing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash provided by financing activities in the nine months ended September 30, 2022 was primarily related to the proceeds on the $5.0 million
WFIA Note received in August 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(153</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
    cash provided by financing activities</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Operating Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in operating activities was $15.9 million for the year ended December 31, 2022. Cash used in operating activities was primarily
due to the use of funds in our operations to develop our product candidates resulting in a net loss of $17.7 million, prior to the effects
of two significant noncash items, stock-based compensation expense of $.8 million and depreciation expense of $0.4 million. Changes in
operating assets and liabilities included a decrease in miscellaneous receivables of $0.5 million due to the collection of research and
development and employee retention tax credits in 2022 as well as an increase in prepaid expenses of $0.4 million due to deposits made
to clinical and manufacturing vendors relating to the initiation of Phase 3 studies for CTx-1301 and deposits to our new CMO for manufacturing
activity.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in operating activities was $10.4 million for the year ended December 31, 2021. Cash used in operating activities was primarily
due to the use of funds in our operations to develop our product candidates resulting in a net loss of $20.7 million, prior to the effects
of two significant noncash items, the one-time noncash PIU charge of $12.7 million and depreciation expense of $0.7 million. Changes
in operating assets and liabilities included a decrease in accounts payable and accrued expenses of $1.3 million mainly due to the payment
of all deferred payroll amounts owed to employees paid in December 2021. There was also an increase in prepaid expense of $1.2 million
primarily relating to a down payment on our annual directors and officers insurance premium which had increased significantly at the
completion of our IPO.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Investing Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash used in investing activities for both the years ended December 31, 2022 and December 31, 2021was primarily related to the purchase
of equipment to support our research and development.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Cash
Flows from Financing Activities</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash provided by financing activities in the year ended December 31, 2022 was primarily related to the proceeds from the $5.0 million
related party note payable to WFIA.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Net
cash provided by financing activities in the year ended December 31, 2021 was primarily related to the issuance of 208,333 shares of
common stock and accompanying warrants in connection with our IPO at a share price of $120.00 per share of common stock and accompanying
warrant. We received gross proceeds of $25.0 million and net proceeds of $20.4 million after deducting underwriter discounts and offering
expenses paid by us. We also received $7.1 million related to the issuance of 3,243,201 equity units of CTx prior to our IPO. We paid
$0.5 million for the repayment of notes payable from related parties in December 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Liquidity
and Capital Resources</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Sources
of Liquidity</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">Since our inception in 2012
through September 30, 2023, we have not generated revenue and have incurred significant operating losses and negative cash flow from
our operations. We believe that the net proceeds from this offering, together with our cash on hand, will satisfy our capital
needs through late second quarter of 2024 under our current business plan. Following this offering, we will need to raise
additional capital to fund our operations and continue to support our planned development and commercialization activities.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white">During
the three months ended September 30, 2023, we sold 76,943 shares of common stock pursuant to the ATM Agreement, for net proceeds of $1,595,429
after deducting $49,502 of compensation to HCW and other administration fees. During the nine months ended September 30, 2023, we sold
82,410 shares of common stock pursuant to the ATM Agreement, for net proceeds of $1,696,407 after deducting $59,898 of compensation to
HCW and other administration fees. Subsequent to September 30, 2023, we did not sell any shares of common stock pursuant to the ATM Agreement.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the three months ended September 30, 2023, we sold 12,000 shares of common stock pursuant to the Lincoln Park Agreement, for net proceeds
of $196,167. During the nine months ended September 30, 2023, we sold 25,500 shares of common stock pursuant to the Lincoln Park Agreement,
for net proceeds of $450,427. Subsequent to September 30, 2023, we sold 283,800 shares of common stock pursuant to the ATM Agreement,
for net proceeds of $3,115,303 after deducting $97,512 of compensation to HCW and other administration fees.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 11, 2023, we received gross proceeds of approximately $1.0 million pursuant to the WFIA Private Placement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 13, 2023, we received gross proceeds of approximately $4.0 million, before deducting the placement agent&#8217;s fees and other
offering expenses, pursuant to the September 2023 Offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management
is also evaluating additional strategies to obtain funding, which may include additional offerings of equity, issuance of debt, or other
capital sources, including potential collaborations with other companies or other strategic transactions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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order to achieve the filing of our NDA for CTx-1301 in the first half of 2025 <FONT STYLE="background-color: white">for potential FDA
approval, after this offering, we believe that we will need approximately $8-10 million of additional capital. </FONT>We
will also need additional capital to advance our other programs and commercialization efforts. However, it is difficult to predict our
spending for our product candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly
faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.</FONT></P>

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policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide
liquidity while producing a modest return on investment. Accordingly, our cash equivalents are invested primarily in money market funds
which are currently providing only a minimal return given the current interest rate environment.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
expect to continue to incur substantial additional operating losses for at least the next several years as we continue to develop our
product candidates and seek marketing approval and, subject to obtaining such approval, the eventual commercialization of our product
candidates. If we obtain marketing approval for our product candidates, we will incur significant sales, marketing and outsourced manufacturing
expenses. In addition, we expect to incur additional expenses to add operational, financial and information systems and personnel, including
personnel to support our planned product commercialization efforts. We also expect to incur significant costs to comply with corporate
governance, internal controls and similar requirements applicable to us as a public company.</FONT></P>

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future use of operating cash and capital requirements will depend on many forward-looking factors, including the following:</FONT></P>

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    outcome, timing and cost of meeting regulatory requirements established by the FDA or other comparable foreign regulatory authorities;</FONT></TD></TR>
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    cost and timing of outsourcing our commercialization efforts, including, sales, marketing and distribution capabilities for any product
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
continue to grow our business over the longer term, we plan to commit substantial resources to research and development, including clinical
trials of our product candidates, and other operations and potential product acquisitions and in-licensing. We have evaluated and expect
to continue to evaluate a wide array of strategic transactions as part of our plan to acquire or in-license and develop additional products
and product candidates to augment our internal development pipeline. Strategic transaction opportunities that we may pursue could materially
affect our liquidity and capital resources and may require us to incur additional indebtedness, seek equity capital or both. In addition,
we may pursue development, acquisition or in-licensing of approved or development products in new or existing therapeutic areas or continue
the expansion of our existing operations. Accordingly, we expect to continue to opportunistically seek access to additional capital to
license or acquire additional products, product candidates or companies to expand our operations, or for general corporate purposes.
Strategic transactions may require us to raise additional capital through one or more public or private debt or equity financings or
could be structured as a collaboration or partnering arrangement. We have no arrangements, agreements, or understandings in place at
the present time to enter into any acquisition, licensing or similar strategic business transaction. In March 2023, we entered into a
Joint Commercialization Agreement with Indegene, Inc., which will provide us with commercialization services for CTx-1301, upon approval
from the FDA, including marketing, sales, market access and distribution, on a fee for service basis.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
we raise additional funds by issuing equity securities or if our debt is converted to equity, our stockholders will experience dilution.
Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences that are not favorable
to us or our existing stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties,
it may be necessary to relinquish valuable rights to our technologies, future revenue streams or product candidates or to grant licenses
on terms that may not be favorable to us. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise
capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development
and commercialization of our product candidates.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Contractual
Obligations</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following summarizes our contractual obligations as of September 30, 2023 that will affect our future liquidity.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
entered into a patent and know-how licensing agreement with BDD Pharma Limited in August 2018. See &#8220;Business &#8211; Material Agreements&#8221;
section of this prospectus for a description of this agreement. We are required to pay BDD Pharma certain amounts in connection with
clinical trial and regulatory milestones. The first milestone payment of $250,000 was paid in February 2023 upon dosing of the first
patient in the Phase 3 adult onset and duration study for CTx-1301. Additional payments will become due upon completion of certain milestones
as defined in the agreement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have entered into agreements with CROs for the pivotal Phase 3 fixed-dose pediatric and adolescent safety and efficacy study for CTx-1301,
which commenced in late July 2023, and the Phase 3 pediatric dose-optimization, onset and duration study, which commenced in early August
2023. We have entered into agreements with a CDMO and other third parties for manufacture of the registration batches for CTx-1301 which
will be needed for submission of the NDA. We have also entered into a joint commercialization agreement with Indegene, Inc., pursuant
to which Indegene will provide commercialization services for CTx-1301, upon approval from the FDA, including marketing, sales, market
access and distribution, on a fee for service basis. These contracts do not contain any minimum purchase commitments and are cancelable
by us upon prior written notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred,
including noncancelable obligations of our service providers, up to the date of cancellation and in some cases, wind-down costs and restoration
costs. The exact amount of such obligations is dependent on the timing of termination and the terms of the related agreement and are
not known.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Going
Concern</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Since
inception we have been engaged in organizational activities, including raising capital and research and development activities. We have
not generated revenues and have not yet achieved profitable operations, nor have we ever generated positive cash flow from operations.
There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. We are subject to those risks
associated with any pre-clinical stage pharmaceutical company that has substantial expenditures for research and development. There can
be no assurance that our research and development projects will be successful, that products developed will obtain necessary regulatory
approval, or that any approved product will be commercially viable. In addition, we operate in an environment of rapid technological
change that is largely dependent on the services of our employees and consultants. Further, our future operations are dependent on the
success of our efforts to raise additional capital. These uncertainties raise substantial doubt about our ability to continue as a going
concern for one year after the issuance date of our financial statements. The accompanying consolidated financial statements have been
prepared on a going concern basis. The consolidated financial statements do not include any adjustments to reflect the possible future
effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the
possible inability of the company to continue as a going concern, which contemplates the continuation of operations, realization of assets
and liquidation of liabilities in the ordinary course of business. We have incurred a net loss for the three and nine-month periods ending
September 30, 2023 and 2022 and had accumulated losses of $86.0 million since inception to September 30, 2023. We anticipate incurring
additional losses until such time, if ever, that we can generate significant revenue from our product candidates currently in development.
Our sources of capital have included private capital raises in various classes of units of CTx prior to the Reorganization Merger, the
issuance of equity securities in connection with our initial public offering, the ATM Agreement, the Lincoln Park Agreement, the WFIA
Debt Financing, the WFIA Private Placement and the September 2023 Offering. Additional financings will be needed by us
to fund our operations and to complete development of and commercialize our product candidates. See &#8220;Liquidity and Capital Resources&#8221;
above for details relating to these agreements which we have entered into in 2023 as potential sources of additional capital. There is
no assurance that such financing will be available when needed or on acceptable terms.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Recently
Issued Accounting Standards</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
June 2016, the FASB issued ASU 2016-13, <I>Measurement of Credit Losses on Financial Instruments </I>which significantly changes the
way entities recognize impairment of many financial assets by requiring immediate recognition of estimated credit losses expected to
occur over their remaining life, instead of when incurred. In November 2018, the FASB issued ASU 2018-19, <I>Codification Improvements
to Topic 326, Financial Instruments&#8211;Credit Losses</I>, which amends Subtopic 326-20 (created by ASU 2016-13) to explicitly state
that operating lease receivables are not in the scope of Subtopic 326-20. Additionally, in April 2019, the FASB issued ASU 2019-04, <I>Codification
Improvements to Topic 326, Financial Instruments&#8212;Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments</I>;
in May 2019, the FASB issued ASU 2019-05, <I>Financial Instruments&#8212;Credit Losses (Topic 326): Targeted Transition Relief</I>; in
November 2019, the FASB issued ASU 2019-10, <I>Financial Instruments&#8212;Credit Losses (Topic 326), Derivatives and Hedging (Topic
815), and Leases (Topic 842): Effective Dates</I>, and ASU 2019-11, <I>Codification Improvements to Topic 326, Financial Instruments&#8212;Credit
Losses</I>; and in March 2020, the FASB issued ASU 2020-03, <I>Codification Improvements to Financial Instruments</I>, to provide further
clarifications on certain aspects of ASU 2016-13. The changes (as amended) are effective for the Company for annual and interim periods
in fiscal years beginning after December 15, 2022. The Company does not expect the adoption of ASU 2016-13 to have a material effect
on its consolidated financial statements.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>JOBS
Act</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0pt; text-align: justify; text-indent: 0.5in; background-color: white">On
April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements
for an &#8220;emerging growth company&#8221;. As an &#8220;emerging growth company,&#8221; we are electing to take advantage of the extended
transition period afforded by the JOBS Act for the implementation of new or revised accounting standards, and as a result, we will comply
with new or revised accounting standards on the relevant dates on which adoption of such standards is required for emerging growth companies.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0pt; text-align: justify; text-indent: 0.5in; background-color: white">Subject
to certain conditions set forth in the JOBS Act, as an &#8220;emerging growth company,&#8221; we are not required to, among other things,
(i) provide an auditor&#8217;s attestation report on our system of internal controls over financial reporting pursuant to Section 404,
(ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall
Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight
Board regarding mandatory audit firm rotation or a supplement to the auditor&#8217;s report providing additional information about the
audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items such
as the correlation between executive compensation and performance and comparisons of the chief executive officer&#8217;s compensation
to median employee compensation. These exemptions will apply until the fifth anniversary of the completion of our IPO or until we no longer
meet the requirements for being an &#8220;emerging growth company,&#8221; whichever occurs first.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="s_001"></FONT>SECURITY
OWNERSHIP AND CERTAIN BENEFICIAL OWNERS AND MANAGEMENT</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 24.5pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table sets forth information about the beneficial ownership of our common stock as of January 25, 2024 (unless otherwise
noted) by:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">each
    person or group known to us who beneficially owns more than 5% of our common stock;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">each
    of our Named Executive Officers; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">all
    of our directors and current executive officers as a group.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-indent: 24.5pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 24.5pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have determined beneficial ownership in accordance with the rules of the SEC. Under these rules, beneficial ownership includes any shares
of common stock as to which the individual or entity has sole or shared voting power or investment power. In computing the number of
shares beneficially owned by an individual or entity and the percentage ownership of that person, shares of common stock subject to options
or warrants held by such person that are currently exercisable or will become exercisable within 60 days of January 25, 2024 are
considered outstanding, although these shares are not considered outstanding for purposes of computing the percentage ownership of any
other person.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"></P>

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                                            of </B></FONT></P> <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Class
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">53,305</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Laurie
    A. Myers</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">5,346</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(4)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">*</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Matthew
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">33,126</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(5)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Louis
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">12,333</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(7)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Unless
    noted otherwise, the address of all listed stockholder is 1901 W. 47th Place, Kansas City, KS 66205. Each of the stockholders listed
    has sole voting and investment power with respect to the shares beneficially owned by the stockholder unless noted otherwise, subject
    to community property laws where applicable.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
    have determined beneficial ownership in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended, which is
    generally determined by voting power and/or dispositive power with respect to securities. Percentage ownership is based on 1,450,171
    shares of common stock issued and outstanding as of January 25, 2024, plus any shares issuable upon exercise of options or
    warrants that are exercisable with 60 days of January 25, 2024 held by such person.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes
    (i) 3,537 shares of our common stock issuable upon exercise of warrants that are currently exercisable, (ii) <FONT STYLE="background-color: white">7,301
    shares of our common stock issuable upon the exercise of stock options that are exercisable within 60 days of </FONT>January 25,
    2024<FONT STYLE="background-color: white">, </FONT>and (iii) 40,392 shares of common stock held by Fountainhead Shrugged, LLC.
    Dr. Schaffer is the manager of Fountainhead Shrugged, LLC and has voting and investment power over the securities held by Fountainhead
    Shrugged, LLC. Does not include 9,558 shares of our common stock issuable upon the exercise of stock options that are not exercisable
    within 60 days of January 25, 2024. </FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    2,932 shares of our common stock issuable upon the exercise of stock options that are exercisable within 60 days of </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">January
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; background-color: white">Includes
    614 shares of our common stock issuable upon the exercise of stock options that are exercisable within 60 days of </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">January
    25, 2024<FONT STYLE="background-color: white">. Does not include 986 shares of our common stock issuable upon the exercise
    of stock options that are not exercisable within 60 days of </FONT>January 25, 2024<FONT STYLE="background-color: white">.
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes
    (i) 7,081 shares of common stock held by Louis G. Van Horn Trust, 12/23/19. Mr. Van Horn is the Trustee of Louis G. Van Horn Trust,
    12/23/19 and has voting and investment power over the securities held by Louis G. Van Horn Trust, 12/23/19 and (ii) <FONT STYLE="background-color: white">2,339
    shares of our common stock issuable upon the exercise of stock options that </FONT>had <FONT STYLE="background-color: white">vested
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes
    (i) 251 shares of our common stock issuable upon exercise of warrants that are currently exercisable, (ii) <FONT STYLE="background-color: white">2,339
    shares of our common stock issuable upon the exercise of stock options that had vested as of December 15, 2023, the effective date
    of Mr. Gilgallon&#8217;s resignation from the Company, </FONT>and (iii) 9,265 shares of common stock held by The Limerick Group,
    LLC. Mr. Gilgallon is the sole member of The Limerick Group, LLC and has voting and investment power over the securities held by
    Limerick Group, LLC.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes
    (i) 185,400 shares of our common stock issuable upon exercise of warrants that are currently exercisable, (ii) 675 <FONT STYLE="background-color: white">shares
    of our common stock issuable upon the exercise of stock options that are exercisable within 60 days of </FONT>January 25,
    2024<FONT STYLE="background-color: white">, </FONT>and (iii) 139,917 shares of common stock held by Werth Family Investment Associates
    LLC. Mr. Werth is the manager of Werth Family Investment Associates LLC and has voting and investment power over the securities held
    by Werth Family Investment Associates LLC. Does not include (x) 975 shares of our common stock issuable upon the exercise of stock
    options that are not exercisable within 60 days of January 25, 2024 and (y) 843,970 shares of our common stock underlying
    pre-funded warrants held by Werth Family Investment Associates LLC that prohibits the holder from exercising such warrants to the
    extent that after giving effect to such issuance after exercise, the holder (together with the holder&#8217;s affiliates and any
    other persons acting as a group together with the holder or any of the holder&#8217;s affiliates) would beneficially own in excess
    of 19.99% of the shares of our common stock outstanding immediately after giving effect to the issuance of the shares of our common
    stock issuable upon exercise of the pre-funded warrants.</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(9)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Includes
    directors and current executive officers. </FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(10)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Does
    not include 17,284 shares of our common stock issuable upon the exercise of stock options that are not exercisable within
    60 days of January 25, 2024 and 843,970 shares of our common stock underlying pre-funded warrants that are not exercisable
    within 60 days of January 25, 2024.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_001"></FONT>CERTAIN
RELATIONSHIPS AND RELATED PARTY TRANSACTIONS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
following is a description of transactions since January 1, 2021 to which we have been a participant in which the amount involved exceeded
or will exceed the lesser of (i) $120,000 and (ii) one percent of the average of our total assets at year-end for the last two completed
fiscal years in which any of our directors, executive officers or holders of more than 5% of our voting securities, or any members of
their immediate family, had or will have a direct or indirect material interest, other than compensation arrangements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Related
Party Notes</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
February 26, 2020, CTx issued a $314,000 promissory note (the &#8220;February Note&#8221;) to Matthew Brams, our Chief Medical Officer.
On September 30, 2020, we issued a $40,000 promissory note (the &#8220;September Note&#8221;, and together with the February Note, the
&#8220;Brams Notes&#8221;) to Mr. Brams. The Brams Notes accrued interest at the rate of 8% per annum. The principal of the Brams Notes
and accrued interest thereon was convertible, at Dr. Brams&#8217; option into preferred units of CTx at a Twenty-Five (25%) Percent discount
to the offered unit price at the time of conversion. We had the right to prepay these notes without penalty or premium. On each of December
30, 2020 and July 1, 2020, we made a $100,000 repayment of the February Note. The February Note, which initially matured on February
24, 2021 was extended for an additional 12 months to February 24, 2022. The September Note, which initially matured on September 30,
2021 was extended to February 24, 2022. On July 1, 2021 we made a $100,000 payment on the February Note and on August 17, 2021, we made
a $50,000 payment on the February Note. As of closing of our IPO, we owed $104,000 and $37,025 in principal and interest, respectively,
on the Brams Notes, which were paid in full in December 2021with IPO proceeds.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
July 25, 2020, CTx issued a $100,000 promissory note (the &#8220;July Note&#8221;) to Raul R. Silva, our Executive Vice President and
Chief Science Officer. The July Note accrued interest at the rate of 8% per annum. The principal of the July Note and accrued interest
thereon was convertible, at Dr. Silva&#8217;s option into preferred units of CTx at a Twenty-Five (25%) Percent discount to the offered
unit price at the time of conversion. We had the right to prepay this note without penalty or premium. The July Note, which initially
matured on July 24, 2021, was extended for an additional seven months to February 24, 2022. As of the closing of our IPO, we owed $100,000
and $11,047 in principal and interest, respectively, on the July Note, which was paid in full in December 2021 with IPO proceeds.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
February 1, 2020, CTx issued a $500,000 promissory note to Dresch, Inc., a former CTx member (the &#8220;Member Note&#8221;, and together
with the Brams Notes and the July Note, the &#8220;Related Party Notes&#8221;). Principal and interest of the Member Note was convertible
upon lender&#8217;s notice into preferred units of CTx at the offered unit prices at the time of conversion. On September 30, 2020, $353,665
was converted to 246,096 Preferred Units of CTx at the current unit price in accordance with the terms of the Member Note leaving a note
payable amount of $146,335. The Member Note, which initially matured on February 1, 2021 was extended for an additional 12 months to
February 1, 2022. As of the closing of our IPO, we owed $146,335 and $39,941 in principal and interest, respectively, on the Member Note,
which was paid in full in December 2021 with IPO proceeds.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Initial
Public Offering </I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Patrick
Gallagher, a member of our Board, is a Senior Managing Director at Laidlaw &amp; Co. and a Managing Partner at Laidlaw Venture
Partners. Laidlaw &amp; Company (UK) Ltd. acted as co-lead book-running underwriter for our IPO, which closed December 10, 2021. The
discounts and commissions paid to Laidlaw &amp; Company (UK) Ltd. in connection with the IPO were approximately $500,000.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>WFIA
Note</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
August 9, 2022, CTx issued a $5.0 million (the &#8220;Original Principal Amount&#8221;) promissory note in favor of WFIA (the &#8220;Original
Note&#8221;). Peter Werth, a member of our Board is manager of WFIA. The Original Note was unsecured with interest accruing at
15% per annum. Outstanding principal and all accrued and unpaid interest were due and payable on August 8, 2025, or 120 days following
written demand made by WFIA during the first five business days of a calendar quarter beginning April 1, 2023. CTx was permitted to
prepay the Original Note, in whole or in part, without premium or penalty; provided, that no amount repaid was permitted to
be reborrowed.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
May 9, 2023, CTx executed an amended and restated promissory note (the &#8220;WFIA Note&#8221;) in favor of WFIA that increased the principal
amount of the Original Note from $5.0 million to $8.0 million.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">On September 8, 2023, we
entered into a note conversion agreement with WFIA, pursuant to which WFIA agreed to convert the Original Principal Amount
under the WFIA Note plus all accrued interest thereon, or $5,812,500, into pre-funded warrants (&#8220;September WFIA
Pre-Funded Warrants&#8221;) to purchase 341,912 shares of our common stock at a conversion price per September WFIA
Pre-Funded Warrant of $17.00.&#160;The September WFIA Pre-Funded Warrants&#160;have no expiration date and are exercisable
immediately at an exercise price of $0.002 per share, to the extent that after giving effect to such exercise, WFIA and its
affiliates would beneficially own, for purposes of Section 13(d) of the&#160;Exchange Act,&#160;no more than 19.99% of the
outstanding shares of Common Stock of the Company.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">On January 25, 2024, we entered
into the January 2024 Note Conversion Agreement and converted the remaining $3.0 million of principal plus all accrued interest, or $3,287,500,
under the note payable to WFIA into the January WFIA Pre-Funded Warrants to purchase 687,043 shares of common stock at a conversion price
per pre-funded warrant of $4.785. The closing price of our common stock on January 24, 2024 was $4.35. The January 2024 Pre-Funded Warrants
have no expiration date and are exercisable immediately at an exercise price of $0.0001 per share, to the extent that after giving effect
to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section 13(d) of the Exchange Act, no more than 19.99%
of the outstanding shares of our common stock.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
outstanding principal and all accrued and unpaid interest was due and payable on August 8, 2025 unless accelerated due to an event of
default. Beginning July 1, 2023, WFIA had the right during the first five business days of each calendar quarter to demand payment of
all outstanding principal and interest 120 days following notice to CTx. CTx was permitted to prepay the WFIA Note, in whole or in part,
without premium or penalty; provided, that no amount repaid was permitted to be reborrowed.</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">
As of September 30, 2023, there was $3,000,000 in principal and $157,339 of accrued interest outstanding under the WFIA Note. As of
the date hereof, the WFIA Note has been paid in full and the Company has no further obligations under the WFIA Note.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>WFIA
August 2023 Private Placement</I></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">On August 11, 2023, we entered
into a Securities Purchase Agreement (the &#8220;August 2023 Purchase Agreement&#8221;) with WFIA and issued, in a private placement
priced at the market under Nasdaq rules, 51,158 shares of our common stock at a purchase price per share of $10.97, for aggregate
gross proceeds to us of approximately $1.0 million, before deducting transaction expenses payable by us (the &#8220;WFIA Private Placement&#8221;).
The WFIA Private Placement closed on August 11, 2023.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Indemnification
of Officers and Directors</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
have entered into indemnification agreements with each of our current directors and executive officers. These agreements require us to
indemnify these individuals to the fullest extent permitted under Delaware law against liabilities that may arise by reason of their
service to us, and to advance expenses incurred as a result of any proceeding against them as to which they could be indemnified. We
also intend to enter into indemnification agreements with our future directors and executive officers.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Policies
and Procedures for Related Party Transactions</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
adopted policies and procedures for related party transactions that prohibit our executive officers, directors, nominees for election
as a director, beneficial owners of more than 5% of any class of our common stock, any members of the immediate family of any of the
foregoing persons and any firms, corporations or other entities in which any of the foregoing persons is employed or is a partner or
principal or in a similar position or in which such person has a 5% or greater beneficial ownership interest, or related parties, from
entering into a transaction with us without the prior consent of our Board acting through the Audit Committee or, in
certain circumstances, the chairman of the Audit Committee. Any request for us to enter into a transaction with a related party,
in which the amount involved will, or may be expected to, exceed $100,000 and such related party would have a direct or indirect interest
must first be presented to our Audit Committee, or in certain circumstances the chairman of our Audit Committee, for review,
consideration and approval. In approving or rejecting any such proposal, our Audit Committee is to consider the material facts
of the transaction, including, but not limited to, whether the transaction is on terms no less favorable than terms generally available
to an unaffiliated third party under the same or similar circumstances, the extent of the benefits to us, the availability of other sources
of comparable products or services and the extent of the related person&#8217;s interest in the transaction. In December 2023, our
four independent members of our Board resigned and we do not currently have an Audit Committee, a Compensation Committee or a Nominating
and Corporate Governance Committee.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_002"></FONT>MANAGEMENT</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Executive
Officers and Directors</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
following table provides information regarding our executive officers and directors with their respective ages as of January 25,
2024:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 30%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Shane
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Jennifer L. Callahan</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Laurie
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Raul
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Matthew
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Peter
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><I>Shane J. Schaffer, PharmD&#160;</I>co-founded
Cingulate in 2012 and has since served as our Chief Executive Officer and Chairman of our Board. Prior to his work at Cingulate,
Dr. Schaffer served as the Managing Director of Sabre Scientific Solutions, from July 2009 through December 2012. Previously, Dr. Schaffer
worked as a Director of National Accounts at Pri-Med Access from September 2008 through May 2009, Senior Marketing at Sanofi from February
2004 through December 2007, and as a Marketing Manager at Novartis from June 2001 through October 2003. From July 1999 through June 2001,
he served as Chief Fellow of the Rutgers Pharmaceutical Industry Fellowship Program and was Senior Fellow at Warner Lambert/Parke Davis
and Pfizer. From June 1997 to July 1999, he worked as a clinical research associate at Hoechst Marion Roussel. Dr. Schaffer has over
25 years&#8217; experience in drug development, commercialization and biotech commercial operation. Dr. Schaffer received his Doctor
of Pharmacy from The University of Kansas School of Pharmacy. We believe that Dr. Schaffer&#8217;s extensive knowledge of the pharmaceutical
industry, his clinical and commercial background in a wide range of therapeutic areas, and his experience serving as our Chief Executive
Officer, qualifies him to serve on our Board.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><I>&#160;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><I>Jennifer L. Callahan</I>
was appointed Senior Vice President and Chief Financial Officer on January 25, 2024. She has served the Company in an accounting role
since January 2017 and was appointed as our Vice President, Corporate Controller in January 2019.&#160; Prior to her role at the Company,
Ms. Callahan served as the Director of Accounting for Meridian Business Services, a local Kansas City accounting firm since 2014 where
she provided outsourced controller services to various businesses, including start-up companies and companies in need of process improvements.
Over the tenure of her career, Ms. Callahan has provided consulting services to companies in a variety of industries and stages. She
started her career with Deloitte where she served in various roles in the audit practice from June 1992 to December 1998. Ms. Callahan
holds a CPA designation and received a BSBA in Accounting and Finance from Creighton University</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><I>Laurie A. Myers, PhD, MBA&#160;</I>has
served as our Executive Vice President and Chief Operating Officer since April 2018 and previously served as a member of our Board from
June 2013 through April 2018 and as our Senior Vice President of Operations from November 2017 to April 2018. Dr. Myers also serves as
a Member of the Board of Advisors of Linea System, LLC, a position she has held since September 2020. Dr. Myers previously served as the
Head of Marketing of Fidia Pharma USA Inc., a wholly owned subsidiary of Fidia Farmaceutici from September 2014 through November 2017.
Dr. Myers was an Adjunct Professor at the College of New Jersey School of Business from January 2012 through December 2014, and served
as President and a Member of the Board of the Hallett David Strategic Group from January 2010 through September 2014. Dr. Myers received
her Doctor of Philosophy in Toxicology from Rutgers Medical School and Rutgers School of Pharmacy, her Masters in Business Administration
from St. Joseph&#8217;s University and her Master of Science and Bachelor of Science from the University of Scranton.&#160;</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Raul
R. Silva, MD&#160;</I>co-founded Cingulate in 2013 and has served as our Executive Vice President and Chief Science Officer since January
2018. He has been in private practice since 2009. Previously, Dr. Silva served as Executive Director of Rockland Children&#8217;s Psychiatric
Center from 2006-2009. He also served as Vice Chairman of The New York University Child Study Center 2005 through 2009. Dr. Silva served
as Deputy Director of Child Psychiatry at Bellevue Hospital Center from 1999 through 2006. Prior to that, he was Director of Child and
Adolescent Psychiatry at St. Luke&#8217;s/Roosevelt Hospital in New York City from 1995 through 1990. He completed his fellowship in
child and adolescent psychiatry at Columbia University&#8217;s St. Luke&#8217;s/Roosevelt Hospital Center in 1990 Dr. Silva completed
a psychopharmacology research fellowship at New York University Medical Center. Dr. Silva is board certified in general, child and adolescent
psychiatry. Dr. Silva received his Doctor of Medicine degree from Ross University and his Bachelor of Science in Biology from Fairleigh
Dickinson University.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Matthew
N. Brams, MD</I>&#160;co-founded Cingulate in 2013 and has served as our Executive Vice President and Chief Medical Officer since January
2018 and served as a director of Cingulate from January 2018 through July 2021. Dr. Brams served as a Principal of Bayou City Research,
a position he held from April 1999 to January 2021. Prior to that, he served as a consultant medical director and/or admitting Psychiatrist
at numerous medical facilities including Taylor Recover Center (April 2019 to present); Lakeview Health Rehabilitation Center (2018-2019);
The Parc, Houston Tx (2012-2015); GeroPsych Unit Gulf Coast Hospital (2009-Present). Dr. Brams has been integral to the research teams
for all the major pharmaceutical companies participating in the ADHD clinical arena. Dr. Brams completed residency and fellowship at
Baylor College of Medicine in adult and child psychiatry, respectively. He is board certified in Adult and Child Psychiatry (1994)
and is an acting Senior Board Examiner for the American Board of Psychiatry and Neurology. He received his Doctor of Medicine from The
University of Texas Science Center and his Bachelor of Arts in Biology from the University of Texas.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Peter
J. Werth&#160;</I>has served on our Board since June 2018. Mr. Werth is Founder and Chief Executive Officer of ChemWerth
Inc., a full-service generic drug development and supply company providing Active Pharmaceutical Ingredients to regulated markets worldwide.
Mr. Werth previously served as Vice President at Ganes Chemicals, a subsidiary of Siegfried Chemicals, from March 1975 through May 1982.
From 1965 through 1975, Mr. Werth worked in Research and Development for Upjohn Pharmaceuticals, now Pfizer (NYSE: PFE). In addition
to serving on the Board of Cingulate, Mr. Werth serves on the Board of Directors of VM Pharma LLC since December 2010, VM Therapeutics
LLC since May 2012, Alopexx Vaccines LLC since June 2012, VM Oncology LLC since August 2014, Perseus Science Group LLC since January
2015, Likarda LLC since August 2017, Techtona LLC since September 2017, MedRhythms LLC since June 2018 and Bastion Healthcare LLC since
September 2020. He earned his Master of Science in Organic Chemistry from Stanford University and his Bachelor of Science in Chemistry
and Math from Fort Hays State University. We believe that Mr. Werth&#8217;s extensive experience in the life sciences industry and his
knowledge in business and international markets qualifies him to serve on our Board.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Family
Relationships</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">There
are no family relationships among any of our directors or executive officers.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Board
Composition</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
Board  currently consists of two members. Our directors hold office until their successors have been elected and qualified
or until the earlier of their resignation or removal.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
accordance with the terms of our amended and restated certificate of incorporation and bylaws, our Board  is divided into
three classes, class I, class II and class III, with each class serving staggered three-year terms. Upon the expiration of the term of
a class of directors, directors in that class will be eligible to be elected for a new three-year term at the annual meeting of stockholders
in the year in which their term expires. Our directors are divided among the three classes as follows:</FONT></P>

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<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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                                            Class I director is Peter J. Werth; his term will expire at the annual meeting of stockholders
                                            to be held in 2025.</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: 0in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.5in"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
                                            Class III director is Shane J. Schaffer; his term will expire at the annual meeting of stockholders
                                            to be held in 2024.</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
currently do not have any Class II Directors. We expect that any additional directorships resulting from an increase in the number of
directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors.
The division of our Board  into three classes with staggered three-year terms may delay or prevent a change of our management
or a change in control.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
amended and restated certificate of incorporation and amended and restated bylaws provide that the authorized number of directors may
be changed only by resolution of our Board. Our amended and restated certificate of incorporation and amended and restated
bylaws also provide that our directors may be removed only for cause, and that any vacancy on our Board, including a vacancy
resulting from an enlargement of our Board, may be filled only by vote of a majority of our directors then in office.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
do not have a formal policy with regard to the consideration of diversity in identifying director nominees. The Board evaluates each
individual in the context of the Board as a whole, with the objective of assembling a group that can best perpetuate the success of the
business and represent stockholder interests through the exercise of sound judgment using its diversity of experience in these various
areas.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Director
Independence</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Pursuant
to the rules of Nasdaq, a director will only qualify as an &#8220;independent director&#8221; if, in the opinion of that company&#8217;s
board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying
out the responsibilities of a director.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Our Board has determined that
we do not currently have any directors that qualify as &#8220;independent directors&#8221; as such term is defined by Nasdaq Marketplace
Rule 5605(a)(2). Due to the promissory note issued by CTx in favor of WFIA, our Board determined that Mr. Werth is not an independent
director. In addition, Shane Schaffer is not an independent director due to his position as Chief Executive Officer of the Company. Scott
Applebaum, who resigned from the Board on December 6, 2023, Patrick Gallagher who resigned from the Board on December 12, 2023 and each
of Gregg Givens and Curt Medeiros&#160;who resigned from the Board on December 13, 2023, were deemed to be independent directors.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">We do not currently have an Audit
Committee, a Compensation Committee nor a Nominating and Corporate Governance Committee, and the Company is in the process of selecting
additional directors. Once additional board members are appointed to our Board, an independence analysis will be performed based on the
listing standards of the Nasdaq Rule.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">On December 26, 2023, we received
a letter from the Staff indicating that, based upon&#160;the resignation of three members of our Board on December 12, 2023 and December
13, 2023,&#160;we&#160;no longer comply with the independent director, audit committee, compensation committee and independent director
oversight of director nominations requirements as set forth in Nasdaq Listing Rule 5605 (the &#8220;Independent Director Rule&#8221;).
We are in the process of identifying potential new directors and intend to show progress in complying with the Independent Director Rule
prior to the Panel hearing. There can be no assurance that we will regain compliance with the Independent Director Rule.</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_003"></FONT>EXECUTIVE
COMPENSATION</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
following tables and accompanying disclosure set forth information about the compensation earned by our named executive officers during
2023. Our named executive officers include our principal executive officer, the two most highly-compensated executive officers (other
than our principal executive officer) serving as executive officers as of December 31, 2023 and two former executive officers that would
have been one of the two most highly-compensated executive officers (other than our principal executive officer) had they been serving
as an executive officer as of December 31, 2023 as set forth below:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Shane
    J. Schaffer, Chief Executive Officer and Chairman of the Board;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Laurie
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Matthew
                                            N. Brams, Executive Vice President and Chief Medical Officer;</FONT></P></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Louis
    G. Van Horn, Former Executive Vice President and Chief Financial Officer; and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Craig
    S. Gilgallon, Esq., Former Executive Vice President, General Counsel and Secretary.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>SUMMARY
COMPENSATION TABLE</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
following table sets forth information regarding compensation awarded to, earned by or paid to each of our named executive officers for
the years shown.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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                                            Position</B></FONT></P></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: bold 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Year</FONT></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 29%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Shane
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 5%; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">2023</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 5%; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">-</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: italic 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Chairman
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    awards in 2022. The assumptions used to estimate the grant date fair value of the stock option awards in February 2023 were as follows:</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"></P>
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&#160;</P>

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    Van Horn retired from the Company, effective December 13, 2023. </FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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    December 15, 2023. Mr. Gilgallon claims his termination was for &#8220;good reason&#8221; pursuant to Section 4(e) of his employment
    agreement with CTx dated September 23, 2021. The Company disputes Mr. Gilgallon&#8217;s claim. Subject to execution of a general
    release in favor of the Company, termination for &#8220;good reason&#8221; pursuant to Mr. Gilgallon&#8217;s employment agreement
    would entitle him to a lump sum payment equal to his base salary ($402,800) and target bonus ($100,500) within 60 days of
    his termination date. In addition, any of Mr. Gilgallon&#8217;s outstanding stock options that would have vested if he
    had remained employed for an additional four (4) months following his termination date shall become vested and exercisable
    as of the termination date and all vested stock options would be exercisable for their full term.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I></I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>&#160;</I></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>&#160;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Employee
Benefit Plans</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
currently provide broad-based health and welfare benefits that are available to all of our employees, including our named executive officers,
including medical, dental, and vision insurance.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>401(k)
Plan</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
sponsor a 401(k) savings plan (the &#8220;401(k) Plan&#8221;) for all eligible employees. Under the 401(k) Plan, we do not make matching
contributions into the 401(k) Plan other than the annual required safe harbor match.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Contingent
Bonus Plan</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
connection with the reduction in annual base salary for all employees, effective December 16, 2023, and to incentivize employees
to remain with the Company, the independent members of the Board approved a contingent bonus plan. Pursuant to this plan,
the Company will pay to each employee on the date that is three months after the filing date of the New Drug Application for CTx-1301
with the FDA (the &#8220;payment date&#8221;) an amount equal to the aggregate dollar amount of base salary through the payment date
that was not paid to the employee due to the salary reductions plus 20% of the reduction amount.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Employment
Arrangements with our Named Executive Officers</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Shane
J. Schaffer</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
September 23, 2021, we entered into an employment agreement with Dr. Schaffer. Under the terms of Dr. Schaffer&#8217;s employment agreement,
he holds the position of Chief Executive Officer. The employment agreement originally provided for a base salary of $475,000 annually,
which was increased to $503,500, effective January 1, 2023. In connection with cost containment measures, Mr. Schaffer&#8217;s annual
base salary was reduced to $226,350, effective December 16, 2023. In addition, Dr. Schaffer is eligible to receive an annual bonus, with
a target amount equal to twenty-five percent (25%) of Dr. Schaffer&#8217;s annual base salary. The actual amount of each bonus will be
determined by the sole discretion of our Compensation Committee and will be based upon both the Company&#8217;s performance and Dr. Schaffer&#8217;s
individual performance. Pursuant to the terms of his employment agreement, Dr. Schaffer is also eligible to participate in all incentive
and deferred compensation programs available to other executives or officers of the Company, and will be eligible to participate in any
employee benefit plans and equity plans that we may adopt, which plans may be amended by the Company from time to time in its sole discretion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
may terminate Dr. Schaffer&#8217;s employment at any time without cause upon providing written notice to Dr. Schaffer, and Dr. Schaffer
may terminate his employment at any time for any reason, including for Good Reason (as that term is defined in Dr. Schaffer&#8217;s employment
agreement).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
Dr. Schaffer&#8217;s employment is terminated by the Company without cause or by Dr. Schaffer for Good Reason, Dr. Schaffer will be entitled
to receive, subject to his signing a general release of claims in favor of the Company and related persons and entities within twenty-one
(21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment of a lump sum amount
in cash equal to one and one half (1 &#189;) times Dr. Schaffer&#8217;s base salary and annual target bonus, within 60 days following
the date of termination. In addition, all stock options and stock appreciation rights held by Dr. Schaffer, which would have vested if
he had remained employed for an additional four (4) months following the date of termination, shall become vested and exercisable as
of the date of termination for the remainder of their full term. If Dr. Schaffer&#8217;s employment is terminated by the Company without
cause or by Dr. Schaffer for Good Reason within twelve (12) months of a Change of Control, Dr. Schaffer will be entitled to receive,
subject to his signing a general release of claims in favor of the Company and related persons and entities within twenty-one (21) days
of the date of termination and following the expiration of seven (7) days thereafter, a severance payment of a lump sum amount in cash
equal to two (2) times Dr. Schaffer&#8217;s base salary and annual target bonus, within 60 days following the date of termination; provided
however, if any payment or benefits would constitute an &#8220;parachute payment&#8221; as defined in Section 280(G) of the Internal
Revenue Code, the payments will be the greater of (i) the largest amount to ensure that no portion of those payments be subject to the
excise tax imposed by Section 4999 of the Internal Revenue Code and (ii) the amount of the full payment, less all taxes, including the
excise tax imposed by Section 4999 of the Internal Revenue Code. In addition, all stock options and stock appreciation rights held by
Dr. Schaffer shall become vested and exercisable as of the date of termination for the remainder of their full term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Laurie
A. Myers</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
September 23, 2021, we entered into an employment agreement with Ms. Myers. Under the terms of Ms. Myers&#8217; employment agreement,
she holds the positions of Executive Vice President and Chief Operating Officer. The employment agreement originally provided for a base
salary of $400,000 annually, which was increased to $424,000, effective January 1, 2023. In connection with cost containment measures,
Ms. Myers&#8217; annual base salary was reduced to $212,000, effective December 16, 2023. In addition, Ms. Myers is eligible to receive
an annual bonus, with a target amount equal to twenty-five percent (25%) of Ms. Myers&#8217; annual base salary. The actual amount of
each bonus will be determined by the sole discretion of our Compensation Committee and will be based upon both the Company&#8217;s performance
and Ms. Myers&#8217; individual performance, as recommended by the Chief Executive Officer. Pursuant to the terms of her employment agreement,
Ms. Myers is also eligible to participate in all incentive and deferred compensation programs available to other executives or officers
of the Company, and will be eligible to participate in any employee benefit plans and equity plans that we may adopt, which plans may
be amended by the Company from time to time in its sole discretion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
may terminate Ms. Myers&#8217; employment at any time without cause upon providing written notice to Ms. Myers, and Ms. Myers may terminate
her employment at any time for any reason, including for Good Reason (as that term is defined in Ms. Myers&#8217; employment agreement).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
Ms. Myers&#8217; employment is terminated by the Company without cause or by Ms. Myers for Good Reason, Ms. Myers will be entitled to
receive, subject to her signing a general release of claims in favor of the Company and related persons and entities within twenty-one
(21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment of a lump sum amount
in cash equal to one (1) times Ms. Myers&#8217; base salary and annual target bonus, within 60 days following the date of termination.
In addition, all stock options and stock appreciation rights held by Ms. Myers, which would have vested if she had remained employed
for an additional four (4) months following the date of termination, shall become vested and exercisable as of the date of termination
for the remainder of their full term. If Ms. Myers&#8217; employment is terminated by the Company without cause or by Ms. Myers for Good
Reason within twelve (12) months of a Change of Control, Ms. Myers will be entitled to receive, subject to her signing a general release
of claims in favor of the Company and related persons and entities within twenty-one (21) days of the date of termination and following
the expiration of seven (7) days thereafter, a severance payment of a lump sum amount in cash equal to one (1) times Ms. Myers&#8217;
base salary and annual target bonus, within 60 days following the date of termination; provided however, if any payment or benefits would
constitute an &#8220;parachute payment&#8221; as defined in Section 280(G) of the Internal Revenue Code, the payments will be the greater
of (i) the largest amount to ensure that no portion of those payments be subject to the excise tax imposed by Section 4999 of the Internal
Revenue Code and (ii) the amount of the full payment, less all taxes, including the excise tax imposed by Section 4999 of the Internal
Revenue Code. In addition, all stock options and stock appreciation rights held by Ms. Myers shall become vested and exercisable as of
the date of termination for the remainder of their full term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>&#160;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Matthew
N. Brams</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
September 23, 2021, we entered into an employment agreement with Mr. Brams. Under the terms of Mr. Brams&#8217;s employment agreement,
he holds the positions of Executive Vice President and Chief Medical Officer. The employment agreement originally provided for a base
salary of $200,000 annually, which was increased to $250,000, effective January 1, 2023. In connection with cost containment measures,
Mr. Brams&#8217; annual base salary was reduced to $125,000, effective December 16, 2023. Effective January 1, 2024, Mr. Brams&#8217;
employment agreement was amended (i) to modify Mr. Bram&#8217;s annual base salary to an amount to allow (a) Mr. Brams to contribute
to the 401(k) Plan the maximum amount permitted by the Internal Revenue Service and (b) the Company to withhold the minimum statutory
amount to satisfy federal, state and local taxes and (ii) to provide that the Company will grant Mr. Brams 1,000 non-qualified stock
options on the last business day of each calendar quarter pursuant to the Company&#8217;s 2021 Omnibus Equity Incentive Plan.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Mr.
Brams is eligible to receive an annual bonus, with a target amount equal to twenty-five percent (25%) of Mr. Brams&#8217;s annual base
salary. The actual amount of each bonus will be determined by the sole discretion of our Compensation Committee and will be based upon
both the Company&#8217;s performance and Brams&#8217;s individual performance, as recommended by the Chief Executive Officer. Pursuant
to the terms of his employment agreement, Mr. Brams is also eligible to participate in all incentive and deferred compensation programs
available to other executives or officers of the Company, and will be eligible to participate in any employee benefit plans and equity
plans that we may adopt, which plans may be amended by the Company from time to time in its sole discretion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
may terminate Mr. Brams&#8217;s employment at any time without cause upon providing written notice to Mr. Brams, and Mr. Brams may terminate
his employment at any time for any reason, including for Good Reason (as that term is defined in Mr. Brams&#8217;s employment agreement).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
Mr. Brams&#8217;s employment is terminated by the Company without cause or by Mr. Brams for Good Reason, Mr. Brams will be entitled to
receive, subject to his signing a general release of claims in favor of the Company and related persons and entities within twenty-one
(21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment in twelve (12) equal
monthly payments equal to one (1) times Mr. Brams&#8217;s base salary, within 60 days following the date of termination. In addition,
all stock options and stock appreciation rights held by Mr. Brams, which would have vested if he had remained employed for an additional
four (4) months following the date of termination, shall become vested and exercisable as of the date of termination for the remainder
of their full term. If Mr. Brams&#8217;s employment is terminated by the Company without cause or by Mr. Brams for Good Reason within
twelve (12) months of a Change of Control, Mr. Brams will be entitled to receive, subject to his signing a general release of claims
in favor of the Company and related persons and entities within twenty-one (21) days of the date of termination and following the expiration
of seven (7) days thereafter, a severance payment of a lump sum amount in cash equal to one (1) times Mr. Brams&#8217;s base salary,
within 60 days following the date of termination; provided however, if any payment or benefits would constitute an &#8220;parachute payment&#8221;
as defined in Section 280(G) of the Internal Revenue Code, the payments will be the greater of (i) the largest amount to ensure that
no portion of those payments be subject to the excise tax imposed by Section 4999 of the Internal Revenue Code and (ii) the amount of
the full payment, less all taxes, including the excise tax imposed by Section 4999 of the Internal Revenue Code. In addition, all stock
options and stock appreciation rights held by Mr. Brams shall become vested and exercisable as of the date of termination for the remainder
of their full term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>&#160;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Louis
G. Van Horn</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
September 23, 2021, we entered into an employment agreement with Mr. Van Horn. Under the terms of Mr. Van Horn&#8217;s employment agreement,
he held the positions of Executive Vice President and Chief Financial Officer. The employment agreement originally provided for a base
salary of $380,000 annually, which was increased to $406,600, effective January 1, 2023. In addition, Mr. Van Horn was eligible to receive
an annual bonus, with a target amount equal to twenty-five percent (25%) of Mr. Van Horn&#8217;s annual base salary. The actual amount
of each bonus was determined by the sole discretion of our Compensation Committee and based upon both the Company&#8217;s performance
and Mr. Van Horn&#8217;s individual performance, as recommended by the Chief Executive Officer. Pursuant to the terms of his employment
agreement, Mr. Van Horn was also eligible to participate in all incentive and deferred compensation programs available to other executives
or officers of the Company, and eligible to participate in any employee benefit plans and equity plans that we adopted.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
had the right to terminate Mr. Van Horn&#8217;s employment at any time without cause upon providing written notice to Mr. Van Horn, and
Mr. Van Horn had the right to terminate his employment at any time for any reason, including for Good Reason (as that term is defined
in Mr. Van Horn&#8217;s employment agreement).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
Mr. Van Horn&#8217;s employment was terminated by the Company without cause or by Mr. Van Horn for Good Reason, Mr. Van Horn would have
been entitled to receive, subject to his signing a general release of claims in favor of the Company and related persons and entities
within twenty-one (21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment
of a lump sum amount in cash equal to one (1) times Mr. Van Horn&#8217;s base salary and annual target bonus, within 60 days following
the date of termination. In addition, all stock options and stock appreciation rights held by Mr. Van Horn, which would have vested if
he had remained employed for an additional four (4) months following the date of termination, would have become vested and exercisable
as of the date of termination for the remainder of their full term. If Mr. Van Horn&#8217;s employment had been terminated by the Company
without cause or by Mr. Van Horn for Good Reason within twelve (12) months of a Change of Control, Mr. Van Horn would have been entitled
to receive, subject to his signing a general release of claims in favor of the Company and related persons and entities within twenty-one
(21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment of a lump sum amount
in cash equal to one (1) times Mr. Van Horn&#8217;s base salary and annual target bonus, within 60 days following the date of termination;
provided however, if any payment or benefits would have constituted a &#8220;parachute payment&#8221; as defined in Section 280(G) of
the Internal Revenue Code, the payments would have been the greater of (i) the largest amount to ensure that no portion of those payments
be subject to the excise tax imposed by Section 4999 of the Internal Revenue Code and (ii) the amount of the full payment, less all taxes,
including the excise tax imposed by Section 4999 of the Internal Revenue Code. In addition, all stock options and stock appreciation
rights held by Mr. Van Horn would have become vested and exercisable as of the date of termination for the remainder of their full term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Mr.
Van Horn retired from his position as our Chief Financial Officer on December 13, 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>Craig
S. Gilgallon, Esq.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">On
September 23, 2021, we entered into an employment agreement with Mr. Gilgallon. Under the terms of Mr. Gilgallon&#8217;s employment agreement,
he held the positions of Executive Vice President and General Counsel. The employment agreement originally provided for a base salary
of $380,000 annually, which was increased to $402,800, effective January 1, 2023. In addition, Mr. Gilgallon was eligible to receive
an annual bonus, with a target amount equal to twenty-five percent (25%) of Mr. Gilgallon&#8217;s annual base salary. The actual amount
of each bonus would have been determined by the sole discretion of our Compensation Committee and based upon both the Company&#8217;s
performance and Mr. Gilgallon&#8217;s individual performance, as recommended by the Chief Executive Officer. Pursuant to the terms of
his employment agreement, Mr. Gilgallon was also eligible to participate in all incentive and deferred compensation programs, and other
executive retirement plans available to other executives or officers of the Company, and would have been eligible to participate in any
employee benefit plans and equity plans that we adopted, which plans may be amended by the Company from time to time in its sole discretion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
had the right to terminate Mr. Gilgallon&#8217;s employment at any time without cause upon providing written notice to Mr. Gilgallon,
and Mr. Gilgallon had the right to terminate his employment at any time for any reason, including for Good Reason (as that term is defined
in Mr. Gilgallon&#8217;s employment agreement).</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
Mr. Gilgallon&#8217;s employment had been terminated by the Company without cause or by Mr. Gilgallon for Good Reason, Mr. Gilgallon
would have been entitled to receive, subject to his signing a general release of claims in favor of the Company and related persons and
entities within twenty-one (21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance
payment of a lump sum amount in cash equal to one (1) times Mr. Gilgallon&#8217;s base salary and annual target bonus, within 60 days
following the date of termination. In addition, all stock options and stock appreciation rights held by Mr. Gilgallon, which would have
vested if he had remained employed for an additional four (4) months following the date of termination, would have become vested and
exercisable as of the date of termination for the remainder of their full term. If Mr. Gilgallon&#8217;s employment had been terminated
by the Company without cause or by Mr. Gilgallon for Good Reason within twelve (12) months of a Change of Control, Mr. Gilgallon would
have been entitled to receive, subject to his signing a general release of claims in favor of the Company and related persons and entities
within twenty-one (21) days of the date of termination and following the expiration of seven (7) days thereafter, a severance payment
of a lump sum amount in cash equal to one (1) times Mr. Gilgallon&#8217;s base salary and annual target bonus, within 60 days following
the date of termination; provided however, if any payment or benefits would have constituted a &#8220;parachute payment&#8221; as defined
in Section 280(G) of the Internal Revenue Code, the payments would have been the greater of (i) the largest amount to ensure that no
portion of those payments be subject to the excise tax imposed by Section 4999 of the Internal Revenue Code and (ii) the amount of the
full payment, less all taxes, including the excise tax imposed by Section 4999 of the Internal Revenue Code. In addition, all stock options
and stock appreciation rights held by Mr. Gilgallon would have become vested and exercisable as of the date of termination for the remainder
of their full term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Mr. Gilgallon resigned as an
officer of the Company and terminated employment with Cingulate Therapeutics LLC, effective December 15, 2023. Mr. Gilgallon resigned
as an officer of the Company and terminated employment with CTx, effective December 15, 2023. Mr. Gilgallon claims his termination was
for &#8220;good reason&#8221; pursuant to Section 4(e) of his employment agreement with CTx dated September 23, 2021. The Company disputes
Mr. Gilgallon&#8217;s claim. Subject to execution of a general release in favor of the Company, termination for &#8220;good reason&#8221;
pursuant to Mr. Gilgallon&#8217;s employment agreement would entitle him to a lump sum payment equal to his base salary ($402,800)
and target bonus ($100,500) within 60 days of his termination date. In addition, any of Mr. Gilgallon&#8217;s outstanding
stock options that would have vested if he had remained employed for an additional four (4) months following his termination
date shall become vested and exercisable as of the termination date and all vested stock options would be exercisable for their
full term.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Outstanding
Equity Awards at 2023 Fiscal Year-End</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

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                                            of shares of our common stock underlying stock options and option exercise price reflects
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
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    may exercise vested stock options up until 90 days following their respective termination dates. Upon expiration of such 90-day
    period all stock options held by Messrs. Van Horn and Gilgallon will be forfeited, including the stock options granted on February
    28, 2023. Mr. Gilgallon resigned as an officer of the Company and terminated employment with CTx, effective December 15, 2023.
    Mr. Gilgallon claims his termination was for &#8220;good reason&#8221; pursuant to Section 4(e) of his employment agreement with
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    to a lump sum payment equal to his base salary ($402,800) and target bonus ($100,500) within 60 days of his termination date.
    In addition, any of Mr. Gilgallon&#8217;s outstanding stock options that would have vested if he had remained employed
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Director
Compensation</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">The following table sets forth
information regarding compensation awarded to, earned by or paid to each of the non-employee members of our Board for their service as
a director during 2023 other than for reimbursement of reasonable expenses incurred in attending meetings of our Board and committees
of our Board.</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>2023
Director Compensation Table</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(1)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
    connection with cost containment measures, the Board deferred the payment of cash fees for the second, third and fourth quarters
    of 2023.</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 24px; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(2)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    amounts reflect the grant date fair value of the non-qualified stock options awarded on June 15, 2023 to the non-employee directors
    as of that date in accordance with FASB ASC Topic 718. The fair market value of the option awards was determined using the Black-Scholes
    Model. The assumptions used to estimate the grant date fair value of the stock option awards in June 2023 were as follows:</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Risk-free
    interest rate 0.04%</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Expected
    term (in years) 5.51</FONT></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Expected
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Expected
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Grant
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Messrs.
    Applebaum, Gallagher, Givens and Medeiros may exercise vested stock options up until ninety (90) days following their
    respective resignation dates. Upon expiration of such 90-day period, all stock options held by Messrs. Applebaum, Gallagher, Givens
    and Medeiros will be forfeited, including the stock options granted on June 15, 2023. As of December 31, 2023: Mr. Conroy
    held no stock options; Mr. Applebaum held 1,350 stock options, of which 600 were vested; and Messrs. Gallagher,
    Givens, Medeiros and Werth held 1,650 stock options, which 675 were vested.</FONT></P></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(3)</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
    following directors resigned from our Board as of the dates indicated: Mr. Applebaum (December 6, 2023); Mr. Conroy (January
    5, 2023); Mr. Gallagher (December 12, 2023); Mr. Givens (December 13, 2023); and Mr. Medeiros (December 13, 2023). </FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>2023
Director Compensation Program</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
Compensation Committee and Board  approved a director compensation program for our non-employee directors, effective June
15, 2023. This program provides for the following annual cash compensation:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">All
cash fees will be paid quarterly in arrears and shall be pro-rated based on the number of whole or partial months served during a calendar
year. Although directors are not paid meeting fees, the lead independent director, if any, and the Chairman of the Compensation Committee
may determine to pay meeting fees for one or more meetings to the extent the number of Board or committee meetings exceeds the typical
number of meetings during the year. We will also reimburse non-employee directors for reasonable expenses incurred in connection with
attending board of director and committee meetings. Non-employee directors will receive an annual stock option award, which will vest
in a single installment on the first anniversary of the date of grant. Each non-employee director as of June 15, 2023 received a non-qualified
stock option award of 750 options on that date. Newly appointed non-employee directors receive an initial non-qualified stock
option award of 1,000 options.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Dr.
Schaffer, our Chief Executive Officer, serves as Chairman of our Board  but does not receive additional compensation for
his service as a director. See the Summary Compensation Table for a description of Dr. Schaffer&#8217;s 2023 compensation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_004"></FONT>USE
OF PROCEEDS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
estimate that the net proceeds from this offering will be approximately $6.5 million after deducting placement agent fees and
estimated offering expenses payable by us and assuming no sale of any pre-funded warrants and no exercise of the warrants. However, because
this is a best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, the actual offering
amount, the placement agent&#8217;s fees and net proceeds to us are not presently determinable and may be substantially less than the
maximum amounts set forth on the cover page of this prospectus, and we may not sell all or any of the securities we are offering. As
a result, we may receive significantly less in net proceeds.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
intend to use all of the net proceeds we receive from this offering for continued research and development and commercialization activities
of CTx-1301, and for working capital, capital expenditures and general corporate purposes, including investing further in research and
development efforts.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Although
we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation
of funds is necessary. The amounts and timing of our actual expenditures will depend upon numerous factors, including our sales and marketing
and commercialization efforts, demand for our products, our operating costs and the other factors described under &#8220;Risk Factors&#8221;
in this prospectus herein. Accordingly, our management will have flexibility in applying the net proceeds from this offering. An investor
will not have the opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use the
proceeds.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Pending
our use of the net proceeds from this offering, we intend to invest the net proceeds in a variety of capital preservation investments,
including short-term, investment-grade, interest-bearing instruments and United States government securities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 27pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_005"></FONT>DILUTION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
you invest in our securities in this offering, your ownership interest will be immediately diluted to the extent of the difference between
the combined public offering price per share and accompanying warrants and the pro forma as adjusted net tangible book value per share
of our common stock immediately after this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 24.5pt; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">As
of September 30, 2023, we had a net tangible book deficit of approximately $(0.1 million), or approximately $(0.11) per share
of common stock. Our net tangible book deficit per share represents our total tangible assets less total liabilities, divided by the
number of shares of our common stock outstanding as of September 30, 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">After giving effect to the Warrant
Exercises and the ATM Sales, our pro forma tangible net book value as of September 30, 2023 would have been approximately $3.0
million, or approximately $2.14 per share of common stock, an increase of approximately $2.25 per share of common stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 24.5pt; background-color: white">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">After giving effect to the
sale of 1,375,000 shares of common stock and accompanying warrants at an offering price of $2.00 per share and
accompanying warrants and pre-funded warrants to purchase up to <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2,375,000
shares of common stock and accompanying warrants at an offering price of $1.9999 per pre-funded warrant and accompanying warrants in
this offering</FONT>, and after deducting placement agent fees and estimated offering expenses payable by us, and assuming all
of the pre-funded warrants offered in this offering are exercised, no exercise of the warrants being offered in
this offering, that no value is attributed to such warrants and that such warrants are classified as and accounted for as equity,
our pro forma as adjusted net tangible book value as of September 30, 2023 would have been approximately $9.6 million, or
approximately $1.85 per share of common stock. This amount represents an immediate decrease in pro forma as adjusted
net tangible book value of $0.29 per share to our existing stockholders and an immediate dilution of $0.15 per share
to investors participating in this offering. We determine dilution per share to investors participating in this offering by
subtracting the pro forma as adjusted net tangible book deficit per share after giving effect to this offering from the public offering price per share and accompanying warrants paid by investors participating in this offering. The following table
illustrates this dilution:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 64%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Public
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right">2.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(0.11</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pro
    forma net tangible book value after giving effect to the Warrant Exercises and the ATM Sales</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Decrease </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">in pro
    forma net tangible book value per share attributable to this offering</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right">(0.29</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">)</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 2.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Dilution
    per share to new investors purchasing shares in this offering</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: right"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$</FONT></TD><TD STYLE="border-bottom: Black 2.5pt double; font: 10pt Times New Roman, Times, Serif; text-align: right">0.15</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
table and discussion above are based on 868,940 shares of our common stock outstanding as September 30, 2023 (1,413,001 shares
of common stock outstanding on a pro forma basis after giving effect to the Warrant Exercises and the ATM Sales), and excludes, as of
such date, the following:&#160;&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">72,638
    shares of our common stock issuable upon exercise of outstanding stock options issued under the 2021 Plan with a weighted average
    exercise price of $59.80 per share;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">66,679
    shares of our common stock that are available for future issuance under the 2021 Plan;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">786,710
    shares of common stock issuable upon the exercise of outstanding warrants with a weighted average exercise price of $46.40 per share;
    and</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">602,173
                                            shares of common stock (1,028,955 shares on a pro forma basis after giving effect
                                            to the Warrant Exercises and the January 2024 Debt Conversion) issuable upon the exercise
                                            of outstanding pre-funded warrants with a weighted average exercise price of $0.002 per share.</FONT></P></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
information discussed above is illustrative only and will adjust based on the actual public offering price and other terms of this offering
determined at pricing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_006"></FONT>DESCRIPTION
OF CAPITAL STOCK</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>The
following description summarizes the most important terms of our securities. Because it is only a summary, it does not contain all the
information that may be important to you. For a complete description, you should refer to our amended and restated certificate of incorporation
and restated bylaws, copies of which are filed as exhibits to the registration statement of which this prospectus forms a part.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Authorized
Capitalization</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
have 250,000,000 shares of capital stock authorized under our amended and restated certificate of incorporation, consisting of 240,000,000
shares of common stock with a par value of $0.0001 per share and 10,000,000 shares of preferred stock with a par value of $0.0001 per
share.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">As
of January 25, 2024, there were 1,450,171 shares of common stock outstanding, and no shares of preferred stock outstanding.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Common
Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Holders
of our common stock are entitled to such dividends as may be declared by our Board out of funds legally available for such purpose.
The shares of common stock are neither redeemable nor convertible. Holders of common stock have no preemptive or subscription rights
to purchase any of our securities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Each
holder of our common stock is entitled to one vote for each such share outstanding in the holder&#8217;s name. No holder of common stock
is entitled to cumulate votes in voting for directors.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
the event of our liquidation, dissolution or winding up, the holders of our common stock are entitled to receive a pro rata share of
our assets, which are legally available for distribution, after payments of all debts and other liabilities. All of the outstanding shares
of our common stock are fully paid and non-assessable.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Preferred
Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
Board has the authority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock in one
or more classes or series and to fix the designations, rights, preferences, privileges and restrictions thereof, without further vote
or action by the stockholders. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights,
terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting, or the designation of, such class
or series, any or all of which may be greater than the rights of common stock. The issuance of our preferred stock could adversely affect
the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon our
liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change in control
of our company or other corporate action. No shares of preferred stock are outstanding, and we have no present plan to issue any shares
of preferred stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Anti-Takeover
Effects of Delaware law and Our Certificate of Incorporation and Bylaws</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
provisions of Delaware law, our amended and restated certificate of incorporation and our amended and restated bylaws described below
may have the effect of delaying, deferring or discouraging another party from acquiring control of us.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Section
203 of the Delaware General Corporation Law</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business
combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder,
with the following exceptions:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">before
    such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in
    the stockholder becoming an interested stockholder;</FONT></TD></TR>
  </TABLE>

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    completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned
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    the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
general, Section 203 defines business combination to include the following:</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
general, Section 203 defines an &#8220;interested stockholder&#8221; as an entity or person who, together with the person&#8217;s affiliates
and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own,
15% or more of the outstanding voting stock of the corporation.</FONT></P>

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of Incorporation and Bylaws</I></B></FONT></P>

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amended and restated certificate of incorporation and amended and restated bylaws provide for:</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">authorizing
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Potential
Effects of Authorized but Unissued Stock</I></B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Pursuant
to our amended and restated certificate of incorporation, we have shares of common stock and preferred stock available for future issuance
without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings
to raise additional capital, to facilitate corporate acquisitions or payment as a dividend on the capital stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
existence of unissued and unreserved common stock and preferred stock may enable our Board to issue shares to persons friendly
to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to
obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management.
In addition, the Board has the discretion to determine designations, rights, preferences, privileges and restrictions,
including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred
stock, all to the fullest extent permissible under the Delaware General Corporation Law and subject to any limitations set forth in our
certificate of incorporation. The purpose of authorizing the Board to issue preferred stock and to determine the rights and preferences
applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred
stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could
have the effect of making it more difficult for a third-party to acquire, or could discourage a third-party from acquiring, a majority
of our outstanding voting stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Choice
of Forum</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Unless
we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and
exclusive forum for any stockholder to bring (i) any derivative action or proceeding brought on behalf of the Company, (ii) any action
asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of the Company or the Company&#8217;s stockholders,
(iii) any action asserting a claim against the Company or any director or officer of the Company arising pursuant to, or a claim against
the Company or any director or officer of the Company, with respect to the interpretation or application of any provision of the DGCL,
our certificate of incorporation or bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine, except for,
in each of the aforementioned actions, any claims to which the Court of Chancery of the State of Delaware determines it lacks jurisdiction.
This provision will not apply to claims arising under the Exchange Act, or for any other federal securities laws which provide for exclusive
federal jurisdiction. However, the exclusive forum provision provides that unless we consent in writing to the selection of an alternative
forum, the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting
a cause of action arising under the Securities Act. Therefore, this provision could apply to a suit that falls within one or more of
the categories enumerated in the exclusive forum provision and that asserts claims under the Securities Act, inasmuch as Section 22 of
the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability
created by the Securities Act or the rules and regulations thereunder. There is uncertainty as to whether a court would enforce such
an exclusive forum provision with respect to claims under the Securities Act.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the
federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased
consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging
lawsuits against our directors and officers.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Transfer
Agent</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
transfer agent of our common stock is Computershare Trust Company, N.A.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_007"></FONT>DESCRIPTION
OF SECURITIES WE ARE OFFERING</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
are offering 1,375,000 shares of our common stock at a combined public offering price of $2.00 per share and accompanying
warrants. We are also offering pre-funded warrants to purchase up to <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2,375,000 shares of common
stock to </FONT> those purchasers whose purchase of shares of our common stock in this
offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99%
(or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock following the consummation of this offering in
lieu of the shares of common stocks that would result in such excess ownership. Each share of our common stock or pre-funded warrant
is being sold together with one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one-half
of a share of common stock. The shares of our common stock and/or pre-funded warrants and related warrants will be issued separately.
We are also registering the shares of our common stock issuable from time to time upon exercise of the pre-funded warrants and warrants
offered hereby.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Common
Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
material terms and provisions of our common stock are described under the caption &#8220;Description of Capital Stock&#8221; in this
prospectus.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Warrants</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>The
following summary of certain terms and provisions of the Series A warrants and Series B warrants that are being offered hereby is not
complete and is subject to, and qualified in its entirety by, the provisions of warrants, the forms of which are filed as exhibits to
the registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions
of the forms of warrant for a complete description of the terms and conditions of the warrants.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Duration
and Exercise Price</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
Series A warrants will have an exercise price of $2.00 per share and will be exercisable immediately. The Series A warrants
will expire on the five-year anniversary of the date of issuance. The Series B warrants will have an exercise price of $2.00
per share and will be exercisable immediately. The Series B warrants will expire on the two-year anniversary of the date of issuance. The exercise price and number of shares of common stock issuable upon exercise of the warrants is subject to appropriate
adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exercise
price. The warrants will be issued separately from the common stock and pre-funded warrants and may be transferred separately immediately
thereafter. The warrants will be issued in certificated form only.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Exercisability</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice
accompanied by payment in full for the number of shares of our common stock purchased upon such exercise (except in the case of a cashless
exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of such holder&#8217;s warrants to
the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at
least 61 days&#8217; prior notice from the holder to us, the holder may increase the amount of ownership of outstanding stock after exercising
the holder&#8217;s warrants up to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the
exercise, as such percentage ownership is determined in accordance with the terms of the warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Cashless
Exercise</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If,
at the time a holder exercises its warrants, a registration statement registering the issuance or resale of the shares of common stock
underlying the warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of
making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder
may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined according
to a formula set forth in the warrant.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Fundamental
Transactions</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
the event of a fundamental transaction, as described in the warrants and generally including any reorganization, recapitalization or
reclassification of our shares of common stock, the sale, transfer or other disposition of all or substantially all of our properties
or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of the voting power represented
by our outstanding shares of capital stock, any person or group becoming the beneficial owner of more than 50% of the voting power represented
by our outstanding shares of capital stock, any merger with or into another entity or a tender offer or exchange offer approved by more
than 50% of the voting power represented by our outstanding shares of capital, then upon any subsequent exercise of a warrant, the holder
will have the right to receive as alternative consideration, for each share of our common stock that would have been issuable upon such
exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor or
acquiring corporation or of our company, if it is the surviving corporation, and any additional consideration receivable upon or as a
result of such transaction by a holder of the number of shares of our common stock for which the warrant is exercisable immediately prior
to such event. Notwithstanding the foregoing, in the event of a fundamental transaction, the holders of the warrants have the right to
require us or a successor entity to redeem the warrants for cash in the amount of the Black-Scholes Value (as defined in each warrant)
of the unexercised portion of the warrants concurrently with or within 30 days following the consummation of a fundamental transaction.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">However,
in the event of a fundamental transaction which is not in our control, including a fundamental transaction not approved by our Board,
the holders of the warrants will only be entitled to receive from us or our successor entity, as of the date of consummation of such
fundamental transaction the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised
portion of the warrant that is being offered and paid to the holders of our common stock in connection with the fundamental transaction,
whether that consideration is in the form of cash, stock or any combination of cash and stock, or whether the holders of our common stock
are given the choice to receive alternative forms of consideration in connection with the fundamental transaction.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Transferability</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Subject
to applicable laws, a warrant may be transferred at the option of the holder upon surrender of the warrant to us together with the appropriate
instruments of transfer.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Fractional
Shares</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">No
fractional shares of common stock will be issued upon the exercise of the warrants. Rather, the number of shares of common stock to be
issued will, at our election, either be rounded up to the next whole share or we will pay a cash adjustment in respect of such final
fraction in an amount equal to such fraction multiplied by the exercise price.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Trading
Market</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">There
is no established trading market for the warrants, and we do not expect such a market to develop. We do not intend to apply to list the
warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of
the warrants will be extremely limited.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Right
as a Stockholder</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Except
as otherwise provided in the warrants or by virtue of the holder&#8217;s ownership of shares of our common stock, such holder of warrants
does not have the rights or privileges of a holder of our common stock, including any voting rights, until such holder exercises such
holder&#8217;s warrants. The warrants will provide that the holders of the warrants have the right to participate in distributions or
dividends paid on our shares of common stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Waivers
and Amendments</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
warrants may be modified or amended or the provisions of such warrants waived with our consent and the consent of the holders of at least
a majority of the outstanding warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Pre-Funded
Warrants</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><I>The
following summary of certain terms and provisions of the pre-funded warrants that are being offered hereby is not complete and is subject
to, and qualified in its entirety by, the provisions of the pre-funded warrant, the form of which will be filed as an exhibit to the
registration statement of which this prospectus forms a part. Prospective investors should carefully review the terms and provisions
of the form of pre-funded warrant for a complete description of the terms and conditions of the pre-funded warrants.</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Duration
and Exercise Price</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Each
pre-funded warrant offered hereby will have an initial exercise price per share of common stock equal to $0.0001. The pre-funded warrants
will be immediately exercisable and will expire when exercised in full. The exercise price and number of shares of common stock issuable
upon exercise is subject to appropriate adjustment in the event of share dividends, share splits, reorganizations or similar events affecting
our shares of common stock and the exercise price.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Exercisability</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
pre-funded warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise
notice accompanied by payment in full for the number of shares of common stock purchased upon such exercise (except in the case of a
cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of the pre-funded warrant
to the extent that the holder would own more than 4.99% of the outstanding shares of common stock immediately after exercise, except
that upon at least 61 days&#8217; prior notice from the holder to us, the holder may increase the amount of beneficial ownership of outstanding
shares after exercising the holder&#8217;s pre-funded warrants up to 9.99% of the number of our shares of common stock outstanding immediately
after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants.
Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants to have the initial
exercise limitation set at 9.99% of our outstanding shares of common stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Cashless
Exercise</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price,
the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of shares of common stock determined
according to a formula set forth in the pre-funded warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Fractional
Shares</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">No
fractional shares of common stock will be issued upon the exercise of the pre-funded warrants. Rather, at the Company&#8217;s election,
the number of shares of common stock to be issued will be rounded up to the next whole share or the Company will pay a cash adjustment
in an amount equal to such fraction multiplied by the exercise price.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Transferability</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Subject
to applicable laws, a pre-funded warrant may be transferred at the option of the holder upon surrender of the pre-funded warrants to
us together with the appropriate instruments of transfer.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>&#160;</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Trading
Market</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">There
is no established trading market for the warrants, and we do not expect such a market to develop. We do not intend to apply to list the
pre-funded warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity
of the pre-funded warrants will be extremely limited.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Right
as a Shareholder</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Except
as otherwise provided in the pre-funded warrants or by virtue of such holder&#8217;s ownership of shares of common stock, the holders
of the pre-funded warrants do not have the rights or privileges of holders of our shares of common stock, including any voting rights,
until they exercise their pre-funded warrants. The pre-funded warrants will provide that the holders of the pre-funded warrants have
the right to participate in distributions or dividends paid on our shares of common stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><I>Fundamental
Transaction</I></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization
or reclassification of our shares of common stock, the sale, transfer or other disposition of all or substantially all of our properties
or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of the voting power represented
by our outstanding shares of capital stock, any person or group becoming the beneficial owner of more than 50% of the voting power represented
by our outstanding shares of capital stock, any merger with or into another entity or a tender offer or exchange offer approved by more
than 50% of the voting power represented by our outstanding shares of capital, then upon any subsequent exercise of a pre-funded warrant,
the holder will have the right to receive as alternative consideration, for each share of our common stock that would have been issuable
upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of shares of common stock of the successor
or acquiring corporation or of our company, if it is the surviving corporation, and any additional consideration receivable upon or as
a result of such transaction by a holder of the number of shares of our common stock for which the pre-funded warrant is exercisable
immediately prior to such event.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Placement
Agent Warrants</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
have also agreed to issue to the placement agent (or its designees) placement agent warrants to purchase up to 150,000 shares
of common stock. The placement agent warrants will be exercisable immediately and will have substantially the same terms as the warrants
described above, except that the placement agent warrants will have an exercise price of $2.50 per share (representing 125 % of the offering price per share and accompanying warrants) and a&#160;termination date that will be five
years from the commencement of the sales pursuant to this offering. See &#8220;Plan of Distribution&#8221; below.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_008"></FONT>PLAN
OF DISTRIBUTION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Pursuant
to an engagement agreement, dated December 27, 2023, as amended, we have engaged H.C. Wainwright &amp; Co., LLC, or the placement
agent, to act as our exclusive placement agent to solicit offers to purchase the securities offered pursuant to this prospectus on a
reasonable best efforts basis. The engagement agreement does not give rise to any commitment by the placement agent to purchase any of
our securities, and the placement agent will have no authority to bind us by virtue of the engagement agreement. The placement agent
is not purchasing or selling any of the securities offered by us under this prospectus, nor is it required to arrange for the purchase
or sale of any specific number or dollar amount of securities. This is a best efforts offering and there is no minimum offering amount
required as a condition to the closing of this offering. The placement agent has agreed to use reasonable best efforts to arrange for
the sale of the securities by us. Therefore, we may not sell all of the shares of common stock, pre-funded warrants and warrants being
offered. The terms of this offering are subject to market conditions and negotiations between us, the placement agent and prospective
investors. The placement agent does not guarantee that it will be able to raise new capital in any prospective offering. The placement
agent may engage sub-agents or selected dealers to assist with the offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Investors
purchasing securities offered hereby will have the option to execute a securities purchase agreement with us. In addition to rights and
remedies available to all purchasers in this offering under federal securities and state law, the purchasers which enter into a securities
purchase agreement will also be able to bring claims of breach of contract against us. The ability to pursue a claim for breach of contract
is material to larger purchasers in this offering as a means to enforce the following covenants uniquely available to them under the
securities purchase agreement: (i) a covenant to not enter into variable rate financings for a period of one year following the closing
of the offering, subject to certain exceptions; and (ii) a covenant to not enter into any equity financings for 90 days from closing
of the offering, subject to certain exceptions. The nature of the representations, warranties and covenants in the securities purchase
agreements shall include:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">standard
    issuer representations and warranties on matters such as organization, qualification, authorization, no conflict, no governmental
    filings required, current in SEC filings, no litigation, labor or other compliance issues, environmental, intellectual property and
    title matters and compliance with various laws such as the Foreign Corrupt Practices Act; and</FONT></TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#9679;</FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">covenants
    regarding matters such as registration of warrant shares, no integration with other offerings, no stockholder rights plans, no material
    nonpublic information, use of proceeds, indemnification of purchasers, reservation and listing of shares of common stock, and no
    subsequent equity sales for 90 days.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
will deliver the securities being issued to the investors upon receipt of investor funds for the purchase of the securities offered pursuant
to this prospectus. We expect to deliver the securities being offered pursuant to this prospectus on or about February 6, 2024.
There is no minimum number of securities or amount of proceeds that is a condition to closing of this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Fees
and Expenses</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
have agreed to pay the placement agent a total cash fee equal to 7.8% of the aggregate gross proceeds raised in the offering.
We will reimburse the placement agent a nonaccountable expense allowance of $50,000, its legal fees and expenses in an amount up to $100,000
and its clearing expense in an amount up to $15,950 in connection with this offering. We estimate the total offering expenses of this
offering that will be payable by us, excluding the placement agent fees and expenses, will be approximately $216,237.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Placement
Agent Warrants</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
addition, we have agreed to issue to the placement agent or its designees warrants, or the placement agent warrants, to purchase up to
4.0% of the aggregate number of shares of common stock sold in this offering (including shares underlying any pre-funded warrants),
at an exercise price equal to 125 % of the public offering price per share and accompanying warrants to be sold in this offering. The
placement agent warrants will be exercisable upon issuance and will expire five years from the commencement of sales under this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">If
at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available
for the resale of warrant shares by the holders of the placement agent warrants, then the placement agent warrants may be exercised,
in whole or in part, at such time by means of a &#8220;cashless exercise&#8221; in which the holders shall be entitled to receive a number
of warrant shares as calculated in the placement agent warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
placement agent warrants provide for customary anti-dilution provisions (for share dividends, splits and recapitalizations and the like)
consistent with FINRA Rule 5110.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Tail</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
the event that any investors that were introduced to the Company by the placement agent (or with whom the Company had a meeting regarding
the offering) during the term of our engagement agreement with the placement agent provide any capital to us in a public or private offering
or capital-raising transaction within twenty-four (24) months following the termination or expiration of our engagement agreement with
the placement agent, we shall pay the placement agent the cash and warrant compensation provided above on the gross proceeds from such
investors. The placement agent will only be entitled to such fee to the extent that the parties are directly introduced to us by the
placement agent, in accordance with FINRA Rule 2010.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Right
of First Refusal</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Subject
to consummation of the offering, we have granted a right of first refusal to the placement agent pursuant to which it has the right to
act as the sole book-running manager, underwriter or placement agent, as applicable, if we decide to raise capital through a public offering
(including an at-the-market facility) or private placement or any other capital-raising financing of equity, equity-linked or debt securities
pursuant to which we engage an investment bank or broker/dealer at any time prior to the twenty-four (24) months following the consummation
of this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Lock-Up
Agreements</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
officers and directors have agreed with the placement agent to be subject to a lock-up period of 90 days following the closing of this
offering. This means that, during the applicable lock-up period, such persons may not offer for sale, contract to sell, sell, distribute,
grant any option, right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly or indirectly, any shares of our
common stock or any securities convertible into, or exercisable or exchangeable for, shares of our common stock. Certain limited transfers
are permitted during the lock-up period if the transferee agrees to these lock-up restrictions. We have also agreed to similar lock-up
restrictions on the issuance and sale of our securities for 90 days following the closing of this offering, subject to certain
exceptions. The placement agent may, in its sole discretion and without notice, waive the terms of any of these lock-up agreements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
addition, subject to certain exceptions, we have agreed to not issue any securities that are subject to a price reset based on the trading
prices of our common stock or upon a specified or contingent event in the future, or enter into any agreement to issue securities at
a future determined price for a period of one year following the closing date of this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Indemnification</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
have agreed to indemnify the placement agent against certain liabilities, including certain liabilities under the Securities Act, or
to contribute to payments that the placement agent may be required to make in respect of those liabilities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
addition, we will indemnify the purchasers of securities in this offering against liabilities arising out of or relating to (i) any breach
of any of the representations, warranties, covenants or agreements made by us in the securities purchase agreement or related documents
or (ii) any action instituted against a purchaser by a third party (other than a third party who is affiliated with such purchaser) with
respect to the securities purchase agreement or related documents and the transactions contemplated thereby, subject to certain exceptions</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Regulation
M Compliance</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any fees received
by it and any profit realized on the sale of our securities offered hereby by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the Securities
Act and the Exchange Act, including, without limitation, Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations
may limit the timing of purchases and sales of our securities by the placement agent. Under these rules and regulations, the placement
agent may not (i) engage in any stabilization activity in connection with our securities; and (ii) bid for or purchase any of our securities
or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until they have completed
their participation in the distribution.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Other
Relationships</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
placement agent and its affiliates have engaged, and may in the future engage, in investment banking transactions and other commercial
dealings in the ordinary course of business with us or our affiliates. The placement agent has received, or may in the future receive,
customary fees and commissions for these transactions.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">In
addition, in the ordinary course of their business activities, the placement agent and its affiliates may make or hold a broad array
of investments and actively trade debt and equity securities (or related derivative securities) for their own account and for the accounts
of their customers. Such investments and securities activities may involve securities and/or instruments of ours or our affiliates. The
placement agent and its affiliates may also make investment recommendations and/or publish or express independent research views in respect
of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such
securities and instruments.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The placement agent serves
as the placement agent pursuant to our at-the-market offering. In connection with the ATM Agreement, the placement agent is entitled
to a commission of 3.0% of the gross proceeds from each sale of shares of our common stock pursuant to such agreement. In connection
with entering into the ATM Agreement, we reimbursed the placement agent $50,000 for its expenses. In addition, we agreed to reimburse
the placement agent up to $2,500 per due diligence update session for expenses of its counsel and any incidental expenses&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">The placement agent served
as the placement agent in connection with the September 2023 Offering. In connection with the September 2023 Offering, the placement
agent received (i) $280,000.01 in placement agent fees, or 7.0% of the gross proceeds raised in September 2023 Offering, and (ii) reimbursement
for its non-accountable expenses in an amount $50,000, legal fees and expenses in the amount of $100,000, and clearing expenses in the
amount of $15,950. In addition, on the closing date of the September 2023 Offering, we issued placement agent warrants to purchase an
aggregate of 17,316 shares of common stock to the placement agent (or its designees). Such placement agent warrants have an exercise
price of $14.44&#160;and expire September 11, 2028.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Electronic
Distribution</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">A
prospectus in electronic format may be made available on a website maintained by the placement agent and the placement agent may distribute
prospectuses electronically. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus
or the registration statement of which this prospectus forms a part, has not been approved and/or endorsed by us or the placement agent
and should not be relied upon by investors.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Transfer
Agent</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
transfer agent and registrar for our common stock is Computershare Trust Company, N.A.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>Nasdaq
listing</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">Our
shares of common stock are listed on Nasdaq under the symbol &#8220;CING.&#8221;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_009"></FONT>LEGAL
MATTERS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">The
validity of the securities offered by this prospectus will be passed upon for us by Lowenstein Sandler LLP, New York, New York. Ellenoff
Grossman &amp; Schole LLP, New York, New York, is counsel for the placement agent in connection with this offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_010"></FONT>EXPERTS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">Our consolidated financial statements
as of December 31, 2022 and 2021, and for each of the years in the two-year period ended December 31, 2022, have been included
herein in reliance upon the report of KPMG LLP, independent registered public accounting firm, appearing elsewhere herein,
and upon the authority of said firm as experts in accounting and auditing. The audit report covering the December 31, 2022 and 2021
consolidated financial statements contains an explanatory paragraph that states that our recurring losses from operations and net capital
deficiency raise substantial doubt about the entity&#8217;s ability to continue as a going concern. The consolidated financial statements
do not include any adjustments that might result from the outcome of that uncertainty.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black"><B><FONT ID="p_011"></FONT>WHERE
YOU CAN FIND MORE INFORMATION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">This
prospectus is part of a registration statement we filed with the SEC. This prospectus does not contain all of the information set forth
in the registration statement and the exhibits to the registration statement. For further information with respect to us and the securities
we are offering under this prospectus, we refer you to the registration statement and the exhibits and schedules filed as a part of the
registration statement. You should rely only on the information contained in this prospectus. We have not authorized anyone else to provide
you with different information. We are not making an offer of these securities in any jurisdiction where the offer is not permitted.
You should assume that the information contained in this prospectus is accurate only as of the date of those respective documents, regardless
of the time of delivery of this prospectus or any sale of our securities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
are subject to the informational requirements of the Exchange Act and in accordance therewith we file annual, quarterly, and other reports,
proxy statements and other information with the Commission under the Exchange Act. Such reports, proxy statements and other information,
including the Registration Statement, and exhibits and schedules thereto, are available to the public through the Commission&#8217;s
website at www.sec.gov.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt; color: Black">We
make available free of charge on or through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934,
as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Commission.
The registration statement and our filings are also available on our website www.cingulate.com. The information contained on, or that
may be accessed through, our website is not part of, and is not incorporated into, this prospectus.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CINGULATE</B><B>,
INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="lpa_002"></FONT>INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 93%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Audited
    Consolidated Financial Statements</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; width: 7%; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_01">Report of Independent Registered Public Accounting Firm</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-</FONT>4</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_02">Consolidated Balance Sheets as of December 31, 2022 and 2021</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-5</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_03">Consolidated Statements of Operations for the years ended December 31, 2022 and 2021</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-6</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_04">Consolidated Statements of Changes in Stockholders&#8217; Equity for the years ended December 31, 2022 and 2021</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-</FONT>7</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_05">Statements of Cash Flows for the years ended December 31, 2022 and 2021</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-8</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_06">Notes to Financial Statements</A></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-9</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Unaudited
    Consolidated Financial Statements</B></FONT></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="#finb_001"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Balance Sheets as of September 30, 2023 and December 31, 2023</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-
    25</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="#finb_002"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2023 and September 30, 2022</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-26</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="#finb_003"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Stockholders&#8217; Equity for the Nine Months Ended September 30, 2023 and September 30, 2022</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-27</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="#finb_004"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and September 30, 2023</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-28</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><A HREF="#finb_005"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Notes to Consolidated Financial Statements</FONT></A></TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-29</FONT></TD></TR>
  </TABLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CINGULATE
INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CONSOLIDATED
FINANCIAL STATEMENTS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Years
Ended December 31, 2022 and 2021</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(With
Report of Independent Registered Public Accounting Firm Thereon)</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CINGULATE
INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Consolidated
Financial Statements</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of and for the years ended December 31, 2022 and 2021</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Table
of Contents</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center; width: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Page</B></FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_01">Report
    of Independent Registered Public Accounting Firm</A></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">(PCAOB
    ID: 185)</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center">F-<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">4</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_02">Consolidated Balance Sheets</A></FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-5</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_03">Consolidated Statements of Operations and Comprehensive Loss</A></FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center">F-<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">6</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_04">Consolidated Statements of Changes in Stockholders&#8217; Equity</A></FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-7</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_05">Consolidated Statements of Cash Flows</A></FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-8</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><A HREF="#f_06">Notes to Consolidated Financial Statements</A></FONT></TD>
    <TD STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">F-9</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT ID="f_01"></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Report
of Independent Registered Public Accounting Firm</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
the Stockholders and Board of Directors</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc.:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Opinion
on the Consolidated Financial Statements</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have audited the accompanying consolidated balance sheets of Cingulate Inc. (the Company) as of December 31, 2022 and 2021, the related
consolidated statements of operations and comprehensive loss, stockholders&#8217; equity, and cash flows for each of the years
in the two-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements). In our opinion,
the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31,
2022, in conformity with U.S. generally accepted accounting principles.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Going
Concern</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements,
the Company has incurred losses from operations, has an accumulated deficit, and will need additional funding for operations and development,
all of which raise substantial doubt about its ability to continue as a going concern. Management&#8217;s plans in regard to these matters
are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome
of this uncertainty.</P>
<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Basis
for Opinion</FONT></P>

<P STYLE="font: italic 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
consolidated financial statements are the responsibility of the Company&#8217;s management. Our responsibility is to express an opinion
on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the
consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures
to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits
provide a reasonable basis for our opinion.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><I>/s/ KPMG LLP</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
have served as the Company&#8217;s auditor since 2020.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Kansas
City, Missouri</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">March
10, 2023, except for Note 19, as to which the date is January 12, 2024</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cingulate Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT ID="f_02"></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated Balance Sheets </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>December 31, 2022 and 2021</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">933</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">690,248</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">57</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Additional Paid-in-Capital</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">73,290,461</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">72,575,584</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Accumulated other comprehensive income</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">165</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt">Total stockholders&#8217; equity</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">20,843,542</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">22,886,257</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements.</FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cingulate Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="f_03"></FONT>Consolidated Statements of Operations and Comprehensive Loss </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Years Ended December 31, 2022 and 2021</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements. </FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cingulate Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="f_04"></FONT>Consolidated Statements of Stockholders&#8217; Equity</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Years Ended December 31, 2022 and 2021</B></FONT></P>


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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(165</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(165</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(85,919</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">57</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">73,290,461</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements</FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cingulate Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT ID="f_05"></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated Statements of Cash Flows </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Years Ended December 31, 2022 and 2021</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">708,317</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">12,738,088</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">43,835</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Changes in operating assets and liabilities:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(538,476</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Prepaid expenses and other current assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(580,591</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(1,258,857</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Operating lease right-of-use assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">227,982</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">100,124</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Trade accounts payable and accrued expenses</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(1,324,686</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Current portion of operating lease liability</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">61,427</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(228,938</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left; padding-bottom: 1.5pt">Other liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(23,615</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(15,882,808</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(10,432,772</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(153,420</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(814,736</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>CINGULATE
INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT ID="f_06"></FONT>Notes
to Consolidated Financial Statements</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
the Years Ended December 31, 2022 and 2021</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(1)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Nature of the Business and Liquidity</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Organization</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables
the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity
Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302
(dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302
utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active
day with a controlled descent of plasma drug level and have favorable tolerability. The Company has initiated Phase 3 clinical trials
for CTx-1301, with first patients in the adult dose-optimization study dosed in early 2023. In addition, the Company has a third product
to treat anxiety, CTx-2103, in a formulation stage.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
November 14, 2012, Cingulate Therapeutics LLC (CTx), a Delaware limited liability company, was formed. On May 10, 2021, Cingulate Inc.
(Cingulate, or the Company), a Delaware corporation and wholly-owned subsidiary of CTx, was formed to serve as a holding company, in
anticipation of the Company becoming publicly traded. Through a Reorganization Merger which occurred in the third quarter of 2021, Cingulate
effectively acquired CTx and all outstanding units of CTx were converted into shares of Cingulate common stock. CTx remains the entity
through which the Company conducts operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CTx
is the predecessor of Cingulate for financial reporting purposes. The consolidated financial statements and notes for the years ended
December 31, 2022 and 2021 represent the full consolidation of Cingulate and its subsidiaries, including CTx and all references to the
Company represent this full consolidation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Liquidity</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent
on the ability to raise capital to support operations until such time as the product candidates under development are U.S Food and Drug
Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. The IPO, which was completed
in December 2021, provided the Company the ability to continue its research and development activities. In addition, the Company received
proceeds of $5.0 million from a promissory note in August 2022 as further described in Note 7. However, the Company will need additional
funding for operations and development. In January 2023, the Company entered into an At The Market Offering Agreement (the &#8220;ATM
Agreement&#8221;) with H.C. Wainwright &amp; Co., LLC, as sales agent (&#8220;Wainwright&#8221;), pursuant to which the Company may offer
and sell, from time to time through Wainwright, shares of its common stock for aggregate proceeds of up to $2,650,000. Additionally,
management is evaluating various strategies to obtain funding which may include additional offerings of common stock, issuance of debt,
or other capital sources, including potential collaborations with other companies or other strategic transactions. Successful implementation
of these plans involves both the Company&#8217;s efforts and factors that are outside its control, such as market factors and FDA approval
of product candidates. The Company can give no assurance that its plans will be effectively implemented in such a way that they will
sufficiently alleviate or mitigate the conditions and events noted above, which results in substantial doubt about the Company&#8217;s
ability to continue as a going concern within one year after the date that the financial statements are issued. The accompanying consolidated
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities
in the normal course of business. The consolidated financial statements do not reflect any adjustments that might result from the outcome
of this uncertainty.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(2)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Summary of Significant Accounting Policies</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (&#8220;U.S.
GAAP&#8221;). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(b)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Use of Estimates</B></FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the reported amounts of expenses during a reporting period. Actual results could differ from estimates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Estimates
and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the
period they are determined to be necessary.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal
Deposit Insurance Corporation limit of $250,000 (without regard to reconciling items). Management monitors the soundness of these financial
institutions and does not believe the Company is subject to any material credit risk relative to the uninsured portion of the deposits.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(d)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Cash and Cash Equivalents</B></FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Bank
demand deposit accounts and short-term liquid investments with an initial maturity of three months or less are considered cash and cash
equivalents. Cash and cash equivalents as of December 31, 2022 and 2021 consisted of bank deposits and short-term money market funds.
Cash and cash equivalents are carried at cost which is indicative of fair value.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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receivables consist of payroll tax credits generated from the Company&#8217;s 2021 and 2020 federal income tax returns, which have not
yet been received, as well as employee retention tax credits for payroll costs incurred in those years. The Company analyzed IAS 20, <I>Accounting for Government Grants and Disclosure
of Government Assistance</I>&#8221;, in accounting for these receivables. As of December 31, 2022 and 2021,
the Company determined that there was no allowance necessary relating to these receivables.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(f)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Property and Equipment, net</B></FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Property
and equipment, net are stated at cost, less accumulated depreciation. Maintenance and repairs are charged to expense when incurred. Property
and equipment are depreciated using the straight-line method over the estimated remaining useful lives or, for leasehold improvements
or leased assets under a financing lease, the life of the lease if shorter.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(g)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Leases</B></FONT></P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company is a lessee in two noncancellable operating leases, relating to office space at the Kansas City headquarters office and the New
Jersey office and two finance leases, for certain furniture and equipment, one of which the lease term ended on December 31, 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company determines if an arrangement is or contains a lease at contract inception. The Company recognizes a ROU asset and a lease liability
at the lease commencement date. For operating leases, the lease liability is initially and subsequently measured at the present value
of the unpaid lease payments at the lease commencement date. For finance leases, the lease liability is initially measured in the same
manner and date as for operating leases and is subsequently measured at amortized cost using the effective-interest method.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company determines the discount rate it uses to discount the unpaid lease payments to present value, which requires management judgement.
ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot
be readily determined, its incremental borrowing rate. The implicit rate was stated in the agreement for one of the Company&#8217;s leases;
however, for the others, the implicit rate was not determinable as the Company did not have access to the lessor&#8217;s estimated residual
value or the amount of the lessor&#8217;s deferred initial direct costs. Therefore, the Company uses its incremental borrowing rate as
the discount rate for these leases. The Company&#8217;s incremental borrowing rate for a lease is the rate of interest it would have
to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. Because the Company has not been
able to borrow on a collateralized basis, it has determined a synthetic credit rating based on factors that a credit rating agency would
typically analyze when establishing an entity&#8217;s credit rating. Due to the fact that the Company is a pre-revenue entity, the Company
determined that its incremental borrowing rate should be based on the composite CCC and lower bond spreads at the lease measurement dates
plus a risk-free rate based on specific lease maturities.</FONT></P>

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or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received.</FONT></P>

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operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus
initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of cumulative lease incentives
received. Lease expense is recognized on a straight-line basis over the lease term which includes the accretion of the lease liability
and amortization of the ROU asset.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier
of the end of its useful life or the end of the lease term unless the lease transfers ownerships of the underlying asset to the Company
or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized
over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented separately from interest expense
on the lease liability.</FONT></P>

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of operating lease liabilities are presented separately on the consolidated balance sheet. Finance lease ROU assets are included in property,
plant, and equipment. The current and long-term portions of finance lease liabilities are presented separately on the consolidated balance
sheet.</FONT></P>

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or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances may
include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows. If
an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future
undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying
amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying
value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the years ended December 31, 2022 or
2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&#160; <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(i)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Research and Development</B></FONT></P>




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product candidates. These expenses include payments to third parties for research, development and manufacturing services, personnel
costs and depreciation on manufacturing equipment. At the end of the reporting period, the Company compares payments made to third party
service providers to the estimated progress toward completion of the research or development objectives. Such estimates are subject to
change as additional information becomes available. Depending on the timing of payments to service providers and the progress that the
Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to
these costs.</FONT></P>

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Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value
using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized
over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information
in Note 11.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(k)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Paycheck Protection Program</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
March 27, 2020, the U.S. federal government enacted the Coronavirus Aid, Relief, and Economic Security Act (&#8220;CARES Act&#8221;).
The CARES Act includes a provision for a Paycheck Protection Program (&#8220;PPP&#8221;) administered by the U.S. Small Business Administration
(&#8220;SBA&#8221;) and further amended by the Paycheck Protection Program Flexibility Act of 2020 (&#8220;PPP Flexibility Act&#8221;),
which was enacted on June 5, 2020. In April 2020, the Company received a PPP Loan of $312,500. In February 2021, the Company received
a second PPP loan of $236,457. In accordance with the requirements of the CARES Act, as amended by the PPP Flexibility Act, the PPP Loans
may be fully forgiven if proceeds are used to pay eligible payroll costs, rent, mortgage interest and utilities.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
July 2021, the Company was notified that the first PPP loan was forgiven by the SBA and in October 2021, the Company was notified that
the second PPP loan was forgiven by the SBA. The Company analyzed IAS 20, <I>Accounting for Government Grants and Disclosure of Government Assistance</I>&#8221;,
in accounting for these loans.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&#160; <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(l)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Segments</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Operating
segments are components of a Company for which separate financial information is available and is evaluated regularly by the Company&#8217;s
chief operating decision-maker in deciding how to allocate resources and in assessing performance. The Company currently operates in
one operating business segment-drug development.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt">&#160; <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(m)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Income Taxes</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact
of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as
measured by tax laws and regulations. As of December 31, 2022, CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of
the activity for CTx, along with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and
deferred tax assets and liabilities for Cingulate Inc. The Company determined that it was more likely than not that it would not realize
its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among other items, therefore a
full valuation allowance is recorded.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has not identified any uncertain tax positions. There have been no interest or penalties recognized in the consolidated financial
statements related to uncertain tax positions. In addition, no tax positions exist for which it is reasonably possible that the total
amounts of unrecognized tax benefits will significantly increase or decrease within the next 12 months.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company files income tax returns in the federal and various state jurisdictions. These federal income taxes are immaterial. The Company
is no longer subject to U.S. federal income tax examinations by tax authorities for years before 2019.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(n)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Common Stock Purchase Warrants</B></FONT></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company issued warrants in connection with its IPO in December 2021. These equity instruments were valued at fair value when they were
issued. See additional information in Note 12.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(o)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Net Loss per Share </B></FONT></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Basic
net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period,
without consideration to potential dilutive securities. Diluted net loss per common share is computed by dividing the net loss by the
sum of the weighted average number of common shares outstanding during the period plus the number of potential dilutive instruments outstanding
during the period using the simplified method. Diluted net loss per share is the same as basic net loss per share since the effect of
potentially dilutive securities is anti-dilutive.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(3)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT>Prepaid
Expenses and Other Current Assets</FONT></B></FONT></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT STYLE="display: none">Prepaid
Expenses</FONT></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prepaid
expenses and other current assets consisted of the following at December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Schedule
of Prepaid Expenses</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Total prepaid expenses</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(4)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Property and Equipment</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Property
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule
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<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">1,739,699</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">1,643,150</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(1,666,055</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Depreciation
expense was $394,011 and $708,317 for the years ended December 31, 2022 and 2021, respectively</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(5)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Accrued Expenses</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accrued
expenses consisted of the following at December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT><FONT STYLE="display: none">Schedule of Accrued Expenses</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Total
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(6)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Contingencies </B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise.
A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material
loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, <I>&#8220;Contingencies.&#8221;
</I>If a range of loss is estimated, and some amount within that range appears to be a better estimate than any other amount within that
range, then that amount is accrued. If no amount within the range can be identified as a better estimate than any other amount, we accrue
the minimum amount in the range. These amounts are not reduced by amounts that may be recovered under insurance or claims against third
parties, but undiscounted receivables from insurers or other third parties may be accrued separately if recovery is considered probable.
Management&#8217;s judgment is required related to loss contingencies because the outcomes are difficult to predict, and the ultimate
resolution may differ from our current analysis. The Company revises accruals in light of new information. While it is not possible to
predict the outcome of loss contingencies with certainty, management is of the opinion that adequate provision for potential losses associated
with any such matters has been made in the financial statements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(7)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT>Related Party Notes Payable</FONT></B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Related
Party Note Payable</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 10, 2022, the Company received $5,000,000 of debt financing from Werth Family Investment Associates LLC (WFIA). Peter Werth, manager
of WFIA, is a member of the Company&#8217;s Board of Directors. This promissory note is unsecured with interest accruing at 15% per annum.
Outstanding principal and all accrued and unpaid interest are due and payable on August 8, 2025, or 120 days following written demand
made by WFIA during the first five business days of a calendar quarter beginning April 1, 2023. The Company may prepay the note, in whole
or in part, without premium or penalty; provided, that no amount repaid may be reborrowed. As of December 31, 2022, the entire $5,000,000
was outstanding on the note.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the year ended December 31, 2022, the Company recognized $292,339 of interest expense relating to this note. This interest expense is
included in accrued expenses on the consolidated balance sheet at December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(8)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Members&#8217; Capital</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prior
to the Reorganization Merger, the Company had multiple classes of Members&#8217; capital, comprised of Founders Units, Class B, D, E,
F and G Preferred Units, and Class C Profits Interests. Class B, E, F and G Preferred Units had similar rights specifically related to
cash distributions as a return of invested capital. Class D Preferred Units had all the rights of Founders and the other Classes of Preferred
Units plus some additional rights noted below. All classes of Members&#8217; capital had voting rights. The Company maintained capital
accounts for each Member. 3,243,201 Units of Class F and Class G were issued during the year ended December 31, 2021, prior to the Reorganization
Merger.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Class
F Preferred Units</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
CTx Board authorized 6,984,985 Class F Preferred Units in two tranches; all authorized Class F Units were issued prior to the Reorganization
Merger. The Company raised a total of $11.3 million from issuance of Class F Units. The newly created Class F Units as authorized by
the CTx Board and as reflected in the 3<SUP>rd</SUP> Amended and Restated Operating Agreement to reflect the creation of the Class F
Units became effective on December 14, 2018.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Class
G Preferred Units</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
CTx Board authorized 12,000,000 Class G Preferred Units; 2,998,184 were issued prior to the Reorganization Merger. The Company raised
a total of $6.7 million from issuance of Class G Units. The newly created Class G Units as authorized by the CTx Board became effective
on February 9, 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Distributions,
if any, from the Company were to be made first to the holders of Class B, D, E, F and G Preferred Units, pro rata in proportion to each
such Member&#8217;s unreturned capital contributions. Distributions were then to be made to all Members including Founders Units, pro
rata in proportion to the number of units held by each Member, with consideration given to the applicable distribution thresholds for
Class C Profits Interests at which each was issued and as disclosed in each Profits Interest Unit agreement, as further described in
Note 9.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Costs
associated with issuance of the Units is immaterial. Pursuant to the terms of the Reorganization Merger, all Units were converted into
shares of common stock of Cingulate, as further described in Note 1.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(9)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Profits Interest Plan</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
2017, the CTx Board established and adopted the Cingulate Therapeutics LLC Equity Incentive Plan (the &#8220;Plan&#8221;) to provide
for issuance of Class C PIU&#8217;s to employees, CTx Members, Board members and service providers of the Company, as defined in the
Plan, eligible to receive PIU&#8217;s as an incentive under the Plan. PIU&#8217;s were granted at the discretion of the Board of Managers
of the Company and in some cases at the discretion of the Chief Executive Officer of the Company based upon Board authorization. The
PIU&#8217;s were issued at a Distribution Threshold equal to the pre-money fair market valuation of the Company at the date of issuance.
The Distribution Threshold was the amount by which a cash distribution, made pro rata to all Members, if any, must have been exceeded
in order for a particular PIU holder to participate in the allocated distribution beyond that threshold. Based on the terms of the award,
the Distribution Threshold was treated as a performance condition for purposes of financial statement recognition. The PIU&#8217;s vesting
period with respect to the service condition was defined in the PIU award agreement and ranged from 30 days to three years with an average
vesting period for all PIU&#8217;s granted of 107 days. As defined in the Company&#8217;s Operating Agreement, all PIU&#8217;s issued
under the Plan entitled the holder to participate pro rata in the profits, if any, of the Company over the stated Distribution Threshold,
assuming a cash distribution was generally made to all Members, subject to any preference or priorities of the other classes of Units.
The Class C PIU&#8217;s also held voting rights on a one-for-one basis.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Immediately
prior to the Reorganization Merger, the Company had granted and issued 8,500,000 and PIU&#8217;s, net of forfeitures. The Company accounted
for these awards under FASB ASC Topic 718<I>, Compensation &#8211; Stock Compensation, </I>as equity classified awards. No compensation
expense was recorded prior to the Reorganization Merger related to the PIU&#8217;s as the future achievement of the thresholds and targets
(the performance condition) to achieve payout was not deemed probable. This assessment was made based on the Company&#8217;s history
of operating losses and continued challenges in raising necessary equity capital to fund operations. In connection with the Reorganization
Merger, as further described in Note 1, 8.5 million PIU&#8217;s were exchanged for 57,900 shares of Cingulate common stock. The exchange
of PIU&#8217;s for common stock created a modification of the terms, character and rights of the PIU&#8217;s and achievement of performance
was considered probable. This resulted in the Company recognizing a noncash modification charge equal to $12.7 million, which charge
was calculated based on the Company&#8217;s assessment of the fair value of the shares of Cingulate common stock on the date of the modification.
$8.2 million of this charge was recorded to general and administrative expense and $4.5 million was recorded to research and development
expense.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following summarizes the activity of the Company&#8217;s Plan:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary of Stock Option Activity</FONT></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Thresholds</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Forfeited</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Converted to common shares upon Reorganization Merger</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prior
to the Reorganization Merger, the Company had issued all units available under the Plan and all units had vested based upon the vesting
period as outlined in the PIU agreement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">PIUs
issued and outstanding prior to the Reorganization Merger, which was also the modification date, at the various distribution thresholds
were as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule
of Various Distribution Thresholds</FONT></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 7%; text-align: right">4,878,200</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">2018</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">661,525</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">217,725</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">22,883</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">902,133</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">2019</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">377,524</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">458,924</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">836,448</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">2020</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,476,126</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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<!-- Field: Split-Segment; Name: 001 -->
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(10)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Stockholders&#8217; Equity</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has authorized 240,000,000 shares of $0.0001 par value common stock and 10,000,000 shares of $0.0001 par value preferred stock
at December 31, 2022 and 2021 of which 565,470 shares of common stock were issued and outstanding. The Company has not issued any
shares of preferred stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">357,137
shares of common stock issued and outstanding were issued in connection with the Reorganization Merger to convert Units of CTx outstanding
immediately prior to the Reorganization Merger and reflects the stock dividend and reverse stock splits described below.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">208,333
shares of common stock were issued at a price to the public of $120.00 per share in connection with the Company&#8217;s IPO, which was
completed in December 2021. The Company received net proceeds of approximately $20.4 million, after deducting underwriting discounts
and commissions and other offering expenses.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation,
dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the
holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Holders
of the shares of common stock are entitled to dividends when, as and if declared by the Board of Directors.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Stock
Dividend</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 30, 2021, the Company effected a stock dividend of 0.0015 shares of common stock for each share of common stock outstanding
(the &#8220;Stock Dividend&#8221;), or an aggregate of 22,402 shares of common stock. No fractional shares of common stock were issued
in connection with the Stock Dividend, and all such fractional interests were rounded down to the nearest whole number.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">No
other dividends had been declared as of December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Reverse
Stock Splits</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>&#160;</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
October 12, 2021, Cingulate effected a reverse stock split of its issued and outstanding shares of common stock at a ratio of 0.0350-for-1,
and on November 29, 2021, Cingulate effected a second reverse stock split of its issued and outstanding shares of common stock at a ratio
of 0.0321-for-1 (the &#8220;Reverse Stock Splits&#8221;). No fractional shares of common stock were issued in connection with either
of the Reverse Stock Splits, and all such fractional interests were rounded down to the nearest whole number. All share data, per share
data and related information for all periods presented in the accompanying consolidated financial statements have been retrospectively
adjusted to reflect the effect of the Reverse Stock Splits, and subsequently adjusted for the Reverse Stock Split, described in Note
1.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(11)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Stock-Based Compensation</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2021, the Company&#8217;s board of directors and stockholders adopted the 2021 Equity Incentive Plan (the &#8220;2021 Plan&#8221;),
which provides for the grant of incentive stock options and non-qualified stock options to purchase shares of the Company&#8217;s common
stock, stock appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance
units, incentive bonus awards, other stock-based awards and other cash-based awards. No awards may be made under the 2021 Plan on or
after September 24, 2031, but the 2021 Plan will continue thereafter while previously granted awards remain outstanding.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
maximum number of shares of common stock available for issuance in connection with options and other awards granted under the 2021 Plan
is 96,391 and as of December 31, 2022, 53,340 shares of common stock were available for issuance under the 2021 Plan. The number of shares of common stock available for issuance under the 2021 Plan will automatically increase on January
1st of each year until the expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common
stock outstanding on December 31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action
prior thereto to provide that there will not be an increase in the share reserve for such year or that the increase in the share reserve
for such year will be of a lesser number of shares of common stock than would otherwise occur. The shares of common stock underlying
any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding,
repurchased or are otherwise terminated by the Company under the 2021 Plan will be added back to the shares of common stock available
for issuance under the 2021 Plan.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company recorded stock-based compensation expense of $800,796 and $43,835 during the years ended December 31, 2022 and 2021, relating
to options issued. As of December 31, 2022 and 2021, there was $2,089,509 and $2,637,895 of unrecognized compensation cost related to
nonvested share-based compensation arrangements granted under the 2021 Plan, which is expected to be recognized over the next one to
four years.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
summary of option activity under the Plan during the years ended December 31, 2022 and 2021 was as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary
of Option Activity</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 95%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s stock options issued qualify for equity accounting treatment under ASC 718 and are measured at fair value as of their
grant date accordingly. The fair value of the options were estimated using a Black-Scholes model. The assumptions that the Company used
to estimate the grant-date fair value of stock options granted to employees and directors were as follows, shown on a weighted average
basis for the respective years ended:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule
of Fair Value Assumption</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Risk-Free
Interest Rate</I>: The Company based the risk-free interest rate over the expected term of the options based on the constant maturity
of U.S. Treasury securities with similar maturities as of the date of grant.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Term:</I> The expected term represents the period that the options granted are expected to be outstanding and is determined using the
simplified method (based on the mid-point between the vesting dates and the end of the contractual term.)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Volatility</I>: The Company uses an average historical stock price volatility of comparable public companies within the biotechnology
and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient
trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information
regarding volatility of its own stock price becomes available.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Dividend Yield</I>: The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected
dividend yield was zero.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
grant-date fair value of options granted during the year ended December 31, 2022 ranged from $17.20 to $23.20 and was $102.60 for options
granted during the year ended December 31, 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair
value of the Company&#8217;s common stock. Because there were no stock options with exercise prices lower than the fair value of the
Company&#8217;s common stock, the aggregate intrinsic value is zero as of December 31, 2022 and 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(12)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT>Common Stock Purchase Warrants </FONT></B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
each of the 208,333 shares of common stock issued in connection with the Company&#8217;s IPO, one common stock purchase warrant was
also issued and included in the unit price of $120.00. These warrants were immediately separable and tradeable. Although the underwriters
did not exercise their fifteen percent over-allotment option to purchase additional shares of common stock, they did purchase 31,250
additional common stock purchase warrants for $.001 per warrant less underwriting discounts and commissions. These 239,583 common stock
purchase warrants have an exercise price of $120.00 per share and provide for a cashless exercise feature if there is no effective registration
statement or current prospectus for the issuance of common stock upon exercise of the warrants. These warrants are exercisable from December
10, 2021 through December 10, 2026. Upon the termination date, these warrants will be automatically exercised via a cashless exercise.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to the common stock purchase warrants noted above, the Company issued 10,417 common stock purchase warrants to the underwriters
for the Company&#8217;s IPO pursuant to the underwriting agreement. These warrants have an exercise price of $150.00 per share and provide
for a cashless exercise feature. These warrants are exercisable from June 7, 2022 through December 10, 2026.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
warrants were valued using a Black-Scholes model with a risk-free rate of .0082%, a term of 5.0 years, and a volatility of 1.24. The
estimated volatility of the Company&#8217;s common stock at the date of measurement is based on an average historical stock price volatility
of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock
price trends as the Company does not have sufficient trading history for its common stock. The risk-free rate is based on the expected
term of the warrants based on the constant maturity of U.S. Treasury securities with similar maturities as of the date of grant. The
expected term has been estimated using the contractual term of the warrants.</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the Company&#8217;s outstanding warrants as of December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary
of Outstanding Warrants</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 85%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Exercise</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Fair Value</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Warrants</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">per Warrant</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Total</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Balance- January 1, 2021</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 36%; text-align: left">Underwritten public offering</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 12%; text-align: right">239,583</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 12%; text-align: right">120.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 12%; text-align: right">95.4000993</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt">Issuance of underwriter warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">10,417</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right">150.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: right">92.7968705</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">966,665</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">Balance- December 31, 2021</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">250,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">23,822,907</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">There
were no warrants issued or exercised in 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has accounted for these warrants as equity-classified instruments under ASC Subtopic 815-40, <I>Accounting for Convertible
Instruments and Contracts in an Entity&#8217;s Own Equity, </I>as they are indexed to the Company&#8217;s common stock, and they
meet all other conditions for equity classification. The gross proceeds of the IPO transaction was
allocated to the common stock and common stock purchase warrants using the relative fair value method shown as follows. Fair value
of the warrants was recorded to Additional Paid-in- Capital on the Company&#8217;s balance sheet.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule
of Fair Value of Warrants to Additional Paid in Capital</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 75%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Percent</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Fair</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">of Total</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Amount</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Value</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Fair Value</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Allocated</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 13%; text-align: right">25,000,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 13%; text-align: right">51.2</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">%</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 13%; text-align: right">12,800,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt">Common Stock Purchase Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">23,822,907</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">48.8</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">%</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">12,200,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">Total</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(13)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Income Taxes</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact
of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as
measured by tax laws and regulations. CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along
with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities
for Cingulate Inc. No deferred income tax benefit or expense was recorded as of December 31, 2022 or December 31, 2021, for federal or
state income taxes.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Income
tax expense differed from the expected expense computed by applying U.S. Federal income tax rate for the respective years ended as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule of Effective Income Tax Rate Reconciliation</FONT></FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 56%; text-align: left">Federal income tax benefit at statutory rate</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(148,393</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 2.5pt">Total income tax expense</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Evaluating
the need for, and amount of, a valuation allowance for deferred tax assets often requires significant judgment and extensive analysis
of all available evidence on a jurisdiction-by-jurisdiction basis. Such judgments require the Company to interpret existing tax law and
other published guidance as applied to its circumstances. As part of this assessment, the Company considers both positive and negative
evidence about its profitability and tax situation. A valuation allowance is provided if, based on available evidence, it is more likely
than not that all or some portion of a deferred tax asset will not be realized. The Company determined that it was more likely than not
that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among
other items. The Company recorded a valuation allowance of its net deferred tax assets totaling $5,580,595
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">and $847,269</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">,
respectively, at December 31, 2022 and 2021, which was recorded as a component of income tax expense on the accompanying consolidated
statements of operations and other comprehensive loss.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company files income tax returns in the U.S. federal and various state jurisdictions. The Companies are not subject to U.S. federal and
state income tax examinations by tax authorities for years before 2018.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company follows the provisions of FASB ASC 740, <I>Income Taxes</I>, to evaluate uncertain tax positions. This topic prescribes a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be
taken in a tax return. The Company has not identified any material uncertain tax positions requiring recognition in the consolidated
financial statements as of December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule of Deferred Tax Assets and Liabilities</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 85%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">December 31, 2021</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Current:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 40pt; text-align: left">Net deferred income tax asset</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">510,676</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Deferred income tax liabilities:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Current:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(105,075</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(14)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Leases</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
June, 2019, the Company executed a lease, which included expansion and renovation of previously leased space for the Kansas City office.
The term of the lease is for a period of five years and commenced on May 1, 2020, the date of receipt of a Certificate of Occupancy for
the expanded and newly renovated space. Under this lease, total rent ranges from $30,453 to $33,145 per month. This lease provided for
a lease incentive by the lessor of tenant improvements totaling $201,600.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company leases office space for its New Jersey based employees from a related party, as further described in Note 17. The base rent for
this lease was $3,000 per month in 2022 and 2021. The lease was entered into in January 2021, for a three-year term.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
2018, the Company entered into an 18-month operating lease for manufacturing equipment. Interim rent was incurred during installation
of the equipment with the lease commencing in June 2018. Monthly lease payments for this leased equipment were $61,786. In December 2019,
this lease was extended for a period of twenty-four months with a monthly lease payment of $37,072. At this date, this lease was modified
for accounting purposes and its classification was assessed as a financing type lease as management determined the lessor to have no
alternative future use of the leased asset. The ROU asset associated with the leased machinery was amortized over the lease term. In
December 2021, the end of the lease term, the Company entered into a purchase agreement with the lessor to purchase the manufacturing
equipment.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
April 2020, the Company entered into a 60-month lease agreement for office furniture under a lease classified as a financing lease as
title of the furniture transfers to the Company at the end of the lease term. Monthly lease payments are $1,491. The leased furniture
is amortized on a straight-line basis over 7 years. The imputed interest rate relating to the lease obligation is 6.12% and the maturity
date is March 2025.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
components of lease cost for the years ended December 31, 2022 and 2021 were as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary of Components of Lease Cost</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Amounts
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT STYLE="display: none">Summary of Lease Reported in Consolidated Balance Sheets</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Operating lease liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">828,503</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left; padding-bottom: 1.5pt">Total operating lease liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">1,124,098</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Finance leases:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Property and equipment</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">76,928</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">76,928</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Accumulated amortization</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(44,988</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left; padding-bottom: 1.5pt">Property and equipment, net</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">31,940</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">47,326</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 0pt; text-align: left">Current installments of obligations under finance leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">16,053</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">15,096</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">finance leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">37,534</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 1.5pt">Long-term portion of obligations under finance leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">37,534</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left; padding-bottom: 2.5pt">Total finance lease liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Other
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary of Other Information Relating to Leases</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">Supplemental cash flow information:</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Reductions to ROU assets resulting from reductions to lease obligations:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Operating leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Weighted average remaining lease term:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Finance leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Weighted average discount rate:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Operating leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Finance leases</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">6.12</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">%</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Maturities
of lease liabilities under noncancellable leases as of December 31, 2022 are as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary of Maturity of Lease Liabilities</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Operating</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Finance</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">leases</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">leases</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 56%; text-align: left">2023</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 18%; text-align: right">414,800</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">17,900</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">2025</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 1.5pt">Thereafter</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Total undiscounted lease payments</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">940,385</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">40,275</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(111,882</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(2,742</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left; padding-bottom: 2.5pt">Total lease liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">828,503</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">37,533</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(15)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Net Loss Per Share </B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table sets forth the computation of the basic and diluted net loss per share for the year ended December 31, 2022 and 2021:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;<FONT STYLE="display: none">Schedule
of Net  Loss Per Share Basic And Diluted</FONT></FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid"></TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2021</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Numerator:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; width: 60%; text-align: left">Net loss</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">(20,709,991</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; padding-bottom: 1.5pt">Weighted average common shares outstanding</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">565,470</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">370,679</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; padding-bottom: 2.5pt">Net loss per share, basic and diluted</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">(31.26</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">(55.87</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">)</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Potentially
dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule of Potentially Dilutive Securities</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2021</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 60%; text-align: left">Stock options issued under the 2021 Equity Incentive Plan</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">43,060</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">250,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; padding-bottom: 2.5pt">Total</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">293,060</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(16)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>License Agreement</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CTx
has a licensing agreement with a company related to the patents and licensed know-how for use in the development of CTx-1301, CTx-1302,
and CTx-2103. CTx will pay the following upon the occurrence of the following milestone events:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment upon dosing of first patient in a Phase 3 Clinical Trial for each product
                                            in the field, payable on a per product basis.</FONT></TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment upon licensee filing of new drug application for each product in the field,
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment for CTx-1301 and CTx-1302 and $500,000 Milestone payment for CTx-2103 upon
                                            receipt of first marketing approval from the FDA, payable on a per product basis.</FONT></TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment for CTx-2103 upon receipt of first marketing approval from the EMA (European
                                            Medicines Agency)</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company accrued the $250,000 milestone for CTx-1301 related to dosing of first patient in a Phase 3 Clinical Trial as of December 31,
2021 as management deemed this milestone to be probable. The Company has not recorded any expense relating to the other milestones for
either product as it has not deemed them probable of occurring as of December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(17)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Related Party Transactions</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
member of the Company&#8217;s Board of Directors, is a Senior Managing Director at Laidlaw &amp; Company (UK) Ltd. Laidlaw &amp; Company
(UK) Ltd. acted as co-lead book-running underwriter for the Company&#8217;s IPO. The discounts and commissions paid to Laidlaw &amp;
Company (UK) Ltd. in connection with the IPO were approximately $500,000 in 2021.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
general counsel of the Company is a partner with a law firm providing office facilities space that is leased by the Company. Rental expense
incurred by the Company to the law firm was $36,000 in 2022 and 2021. As of December 31, 2022 and 2021, the Company owed $0 on this lease.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
member of the Company&#8217;s Board of Directors, Peter Werth, is the manager of WFIA, the entity which provided $5.0 million in debt
financing to the Company in 2022 as described in Note 7. Interest expense of $292,339 was recognized during the year ended December 31,
2022. The full principal balance of $5.0 million and accrued interest of $292,339 was outstanding as of December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(18)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Subsequent Events</B></FONT></P>




<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management
evaluated events that occurred subsequent to December 31, 2022 through March 10, 2023, which is the date the financial statements were
issued.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
January 2023, the Company entered into an At The Market Offering Agreement (the &#8220;ATM Agreement&#8221;) with H.C. Wainwright &amp;
Co., LLC, as sales agent (&#8220;Wainwright&#8221;), pursuant to which the Company may offer and sell, from time to time through Wainwright,
shares of its common stock for aggregate proceeds of up to $2,650,000 (the &#8220;Shares&#8221;). The Company will pay Wainwright a commission
of 3% of the aggregate gross proceeds from each sale of Common Stock. As of the date of this filing, the Company has not made any sales
pursuant to the ATM Agreement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="background-color: white">On </FONT>March 7, 2023<FONT STYLE="background-color: white">,
the Company entered into a Joint Commercialization Agreement with Indegene, Inc., pursuant to which </FONT>Indegene will provide commercialization
services for CTx-1301 upon the Company&#8217;s request. The parties will enter into statements of work that will set forth, among other
things, the services to be performed by Indegene, the deliverables for such services, and the fees to be paid by the Company.&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"></P><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>(19)
                                            Reverse Stock Split</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">On November 30, 2023, the Company completed
a one-for-twenty reverse stock split (the &#8220;Reverse Stock Split&#8221;), which reduced the number of shares of the Company&#8217;s
common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares
of the Company&#8217;s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company&#8217;s common
stock remained unchanged at $0.0001
per share. No fractional shares were issued in connection with the Reverse Stock Split. Except where disclosed, all amounts
related to number of shares and per share amounts have been retroactively restated in these financial statements.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT ID="f_009"></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>PART
I &#8212; FINANCIAL INFORMATION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="f_012"></FONT>Item
1. Financial Statements.</B></FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="finb_001"></FONT>Cingulate
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated
Balance Sheets (unaudited)</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">September 30,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">December 31,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">ASSETS</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Current assets:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; width: 60%; text-align: left">Cash and cash equivalents</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">1,986,313</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">5,356,276</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Miscellaneous receivables</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,836</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">234,432</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Prepaid expenses and other current assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">910,286</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">2,278,944</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Total current assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">2,902,435</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">7,869,652</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Property and equipment, net</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">2,531,330</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">2,904,787</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Operating lease right-of-use assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">436,493</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">630,618</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">Total assets</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">5,870,258</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">11,405,057</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">LIABILITIES AND STOCKHOLDERS&#8217; EQUITY</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Current liabilities:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Accounts payable</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,670,436</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">762,357</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Accrued expenses</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">692,008</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">894,635</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Note payable</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,000,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,000,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Finance lease liability, current</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">16,805</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">16,053</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Operating lease liability, current</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">353,183</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">339,755</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Total current liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,732,432</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">7,012,800</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Finance lease liability, net of current</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">8,792</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">21,487</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Total long-term liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">510,235</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Stockholders&#8217; Equity</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Common Stock, $0.0001 par value; 240,000,000 shares authorized and 868,940 and 565,470 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">88</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">57</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Preferred Stock, $0.0001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Additional Paid-in-Capital</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">85,912,324</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">Total stockholders&#8217; equity</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">Total liabilities and stockholders&#8217; equity</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">11,405,057</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="finb_002"></FONT>Cingulate
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated
Statements of Operations and Comprehensive Loss (unaudited)</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(3,968,362</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(15,962,038</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(13,026,693</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(4,027,247</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(16,600,250</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="finb_003"></FONT>Cingulate
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated
Statements of Stockholders&#8217; Equity (unaudited)</B></FONT></P>

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<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 6%; text-align: right">565,470</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 6%; text-align: right">57</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 6%; text-align: right">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;72,575,584</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 6%; text-align: right">165</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Activity for the three months to March 31, 2022:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Unrealized losses on available for sale investments</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(2,948</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(2,948</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Stock-based compensation expense</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">181,518</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">181,518</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Net loss</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(5,003,511</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(5,003,511</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance March 31, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">57</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">72,757,102</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(56,735,775</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(2,783</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">16,018,601</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Activity for the three months to June 30, 2022:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(466</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(466</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance June 30, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(60,776,222</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(3,249</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Unrealized losses on available for sale investments</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,249</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,249</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Stock-based compensation expense</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">205,656</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">205,656</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Net loss</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(4,027,247</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">57</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">73,169,944</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">(64,803,469</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">8,366,532</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance January 1, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">204,479</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(4,004,887</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(4,004,887</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance March 31, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(73,413,383</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Activity for the three months to June 30, 2023:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">37,369</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">4</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">218,794</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">218,798</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Stock-based compensation expense</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">217,376</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">217,376</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(6,616,309</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(6,616,309</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance June 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">602,839</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">73,931,110</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(80,029,692</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: right">(6,098,521</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Activity for the three months to September 30, 2023:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Issuance of common stock in connection with At the Market Offering and Purchase Agreement, net of fees</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">9</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Issuance of common stock in connection with private placement with WFIA</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">9</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">999,991</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Issuance of common stock and pre-funded warrants sold for cash in public offering, net of fees</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">9</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,310,551</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,949,765</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,949,765</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Capital contribution in connection with conversion of related party note payable</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,862,735</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,862,735</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Stock-based compensation expense</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">236,251</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Net loss</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif">Balance September 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">88</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: White">
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</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT ID="finb_004"></FONT><B>Cingulate
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Consolidated
Statements of Cash Flows (unaudited)&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Miscellaneous receivables</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">642,899</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Prepaid expenses and other current assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(293,140</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Operating lease right-of-use assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">194,125</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">167,828</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">197,462</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Other current liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">31,147</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(249,952</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: left">Net cash used in operating activities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(12,472,172</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(11,676,314</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Investing activities:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(10,400</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(165</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">See
notes to consolidated financial statements</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><FONT ID="finb_005"></FONT>CINGULATE
INC.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Notes
to Consolidated Financial Statements (unaudited)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(1)
Nature of the Business and Liquidity</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Organization</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify; text-indent: -0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is a biopharmaceutical company focused on the development of products utilizing its drug delivery platform technology that enables
the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on the treatment of Attention Deficit/Hyperactivity
Disorder (ADHD). The Company is developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302
(dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302
utilize a flexible core tableting technology with target product profile designed to deliver a rapid onset and last the entire active
day with a controlled descent of plasma drug level and have favorable tolerability. The Company completed its first Phase 3 clinical
trial for CTx-1301 with two additional Phase 3 trials in process. In addition, the Company has a third product to treat anxiety, CTx-2103,
in a formulation stage.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
November 14, 2012, Cingulate Therapeutics LLC (CTx), a Delaware limited liability company, was formed. On May 10, 2021, Cingulate Inc.
(Cingulate, or the Company), a Delaware corporation and wholly-owned subsidiary of CTx, was formed to serve as a holding company, in
anticipation of the Company becoming publicly traded. Through a Reorganization Merger which occurred in the third quarter of 2021, Cingulate
effectively acquired CTx and all outstanding units of CTx were converted into shares of Cingulate common stock. CTx remains the entity
through which the Company conducts operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
consolidated financial statements and notes for the periods ended September 30, 2023 and 2022, represent the full consolidation of Cingulate
and its subsidiaries, including CTx and all references to the Company represent this full consolidation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Liquidity</I></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Company is dependent
on the ability to raise capital to support operations until such time as the product candidates under development are U.S Food and Drug
Administration (FDA) approved, manufactured, commercially available to the marketplace and produce revenues. The initial public offering,
which was completed in December 2021, provided approximately $20.4 million in net proceeds. In addition, the Company received proceeds
of $5.0 million from a promissory note in August 2022 and an additional $3.0 million when the promissory note was amended and restated
in May 2023, a portion of which was subsequently converted to equity, as further described in Note 7. The Company has utilized its At-the-Market
Agreement with H.C. Wainwright and Purchase Agreement with Lincoln Park Capital LLC in 2023, providing a total of approximately $2.1
million in net proceeds through September 30, 2023. Additional capital raised in the third quarter of 2023 included the issuance and
sale of common stock and pre-funded common stock warrants in connection with a public offering, which provided approximately $3.3 million
in net proceeds and the issuance and sale of common stock in connection with a $1 million private placement, as further described in
Note 9. However, the Company will need additional funding for operations and development. Management is evaluating various strategies
to obtain additional funding, which may include additional offerings of equity, issuance of debt, or other capital sources, including
potential collaborations with other companies or other strategic transactions. Successful implementation of these plans involves both
the Company&#8217;s efforts and factors that are outside its control, such as market factors and FDA approval of product candidates.
The Company can give no assurance that its plans will be effectively implemented in such a way that they will sufficiently alleviate
or mitigate the conditions and events noted above, which results in substantial doubt about the Company&#8217;s ability to continue as
a going concern within one year after the date that the financial statements are issued. The accompanying consolidated financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal
course of business. The consolidated financial statements do not reflect any adjustments that might result from the outcome of this uncertainty.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(2)
Summary of Significant Accounting Policies</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(a)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Basis of Presentation and Principles of Consolidation</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S.
GAAP). The consolidated financial statements include the accounts of Cingulate and its wholly-owned subsidiaries. All intercompany accounts
and transactions have been eliminated in consolidation.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(b)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Unaudited Interim Financial Information</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
accompanying consolidated balance sheet as of September 30, 2023, the consolidated statements of operations and comprehensive loss for
the three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of stockholders&#8217; equity for the
three and nine-month periods ended September 30, 2023 and 2022, the consolidated statements of cash flows for the nine-month periods
ended September 30, 2023 and 2022, and the related interim disclosures are unaudited. These unaudited consolidated financial statements
include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results
of operations and cash flows for interim periods in accordance with U.S. GAAP. Interim period results are not necessarily indicative
of results of operations or cash flows for a full year or any subsequent interim period. The accompanying consolidated financial statements
should be read in conjunction with the Company&#8217;s audited consolidated financial statements and the notes thereto as of and for
the year ended December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(c)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Concentration of Credit Risk</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company maintains cash equivalent deposits, which at various times throughout the fiscal year exceeded the amounts insured by the Federal
Deposit Insurance Corporation limit of $250,000 (without regard to reconciling items). Management monitors the soundness of these financial
institutions and does not believe the Company is subject to any material credit risk relative to the uninsured portion of the deposits.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(d)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Miscellaneous Receivables</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Miscellaneous
receivables as of December 31, 2022, primarily consisted of employee retention tax credits for payroll costs incurred in 2020 and research
and development tax credits. The Company analogized to IAS 20, <I>Accounting for Government Grants and Disclosure of Government Assistance</I>,
in accounting for these receivables. As of December 31, 2022, the Company determined that there was no allowance necessary relating to
these receivables. As of September 30, 2023, all employee retention tax credits and research and development tax credits had been collected.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(e)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Impairment of Long-lived Assets</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company assesses the carrying value of its long-lived assets, including property and equipment, as well as lease right of use (ROU) assets,
when events or circumstances indicate that the carrying value of such assets may not be recoverable. These events or changes in circumstances
may include a significant deterioration of operating results, changes in business plans, or changes in anticipated future cash flows.
If an impairment indicator is present, the Company evaluates recoverability by a comparison of the carrying amount of the assets to future
undiscounted cash flows expected to be generated by the assets. If the sum of the expected future cash flows is less than the carrying
amount, the Company would recognize an impairment loss. An impairment loss would be measured by comparing the amount by which the carrying
value exceeds the fair value of the long-lived asset groups. No impairment was recognized during the three or nine-month periods ended
September 30, 2023 or 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(f)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Stock-Based Compensation</B></FONT></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company measures employee and director stock-based compensation expense for all stock-based awards based on their grant date fair value
using the Black-Scholes option-pricing model. For stock-based awards with service conditions, stock-based compensation expense is recognized
over the requisite service period using the straight-line method. Forfeitures are recognized as they occur. See additional information
in Note 11.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(3)
Prepaid Expenses</B></FONT></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Prepaid
expenses consisted of the following at September 30, 2023 and December 31, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="display: none">Schedule of Prepaid Expenses</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">September 30,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">December 31,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 60%; text-align: left">Research and development</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">1,377,391</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Insurance</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">339,676</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">472,152</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">77,422</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">209,156</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Deferred capital raise costs</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">100,339</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">20,775</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">61,524</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Dues and subscriptions</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">38,284</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">37,684</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(4)</B></FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Property and Equipment</B></FONT></P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Property
and equipment, net consisted of the following at September 30, 2023 and December 31, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><FONT STYLE="display: none">Schedule of Property and Equipment</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 85%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 11%; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2-7</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 14%; text-align: right">4,342,832</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">145,754</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Computer equipment</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">5</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">41,898</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">41,898</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Leasehold improvements</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">5</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">471,505</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">471,505</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Construction-in-process- equipment</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">1,739,699</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Property and equipment, gross</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,001,989</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">4,964,853</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Less: accumulated depreciation</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(2,060,066</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Property and equipment, net</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">2,531,330</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">2,904,787</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.25in; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Depreciation
expense for the nine months ended September 30, 2023 was $410,593 and for the nine months ended September 30, 2022 was $304,287. Depreciation
expense for the three months ended September 30, 2023 was $154,663 and for the three months ended September 30, 2022 was $101,429.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(5)
Accrued Expenses</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accrued
expenses consisted of the following at September 30, 2023 and December 31, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="display: none">Schedule
of Accrued Expenses</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 70%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">September 30,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">December 31,</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 60%">Interest</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">157,339</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 16%; text-align: right">292,339</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Research and development</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">253,524</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Professional fees</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">15,000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">314,446</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Employee bonuses</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">175,625</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">175,625</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Active pharmaceutical ingredients</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">62,393</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Other</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">28,127</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">112,225</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Accrued expenses</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">692,008</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">894,635</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(6)
Contingencies </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company may, from time to time, be subject to legal proceedings and claims arising in the ordinary course of business and otherwise.
A substantial legal liability against us could have an adverse effect on our business, financial condition and results of operations.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company records legal costs associated with loss contingencies as incurred and establishes reserves when those matters present material
loss contingencies that management determines to be both probable and reasonably estimable in accordance with ASC 450, <I>Contingencies.
</I>If a range of loss is estimated, and some amount within that range appears to be a better estimate than any other amount within that
range, then that amount is accrued. If no amount within the range can be identified as a better estimate than any other amount, we accrue
the minimum amount in the range. These amounts are not reduced by amounts that may be recovered under insurance or claims against third
parties, but undiscounted receivables from insurers or other third parties may be accrued separately if recovery is considered probable.
Management&#8217;s judgment is required related to loss contingencies because the outcomes are difficult to predict, and the ultimate
resolution may differ from our current analysis. The Company revises accruals in light of new information. While it is not possible to
predict the outcome of loss contingencies with certainty, management is of the opinion that adequate provision for potential losses associated
with any such matters has been made in the consolidated financial statements.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(7)
Related Party Note Payable</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
August 2022, the Company received $5.0 million of debt financing from Werth Family Investment Associates LLC (WFIA). Peter Werth, manager
of WFIA, is a member of the Company&#8217;s Board of Directors. The promissory note, dated August 9, 2023, is unsecured with interest
accruing at 15% per annum. In May 2023, the Company received an additional $3.0 million of debt financing from WFIA by amending and restating
the note to increase the principal amount to $8.0 million. All other terms of the note remained the same.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 8, 2023, the Company and CTx entered into a Note Conversion Agreement (Note Conversion Agreement) with WFIA, pursuant to which
WFIA agreed to convert the original principal amount of $5.0
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">million under the note plus all accrued interest
on the original principal, or $5,812,500</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">,
by issuing pre-funded warrants (WFIA Pre-Funded Warrants) to purchase 341,912
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of the Company&#8217;s common stock
at a conversion price per WFIA Pre-Funded Warrant of $17.00</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">.
The closing price of the Company&#8217;s common stock on Nasdaq on September 8, 2023, was $11.55
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per share. The
WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$0.002
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per
share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section
13(d) of the Securities Exchange Act of 1934, as amended (Exchange Act), no more than 19.99% of the outstanding shares of common stock
of the Company.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company considered ASC 470-60, <I>Troubled Debt Restructurings by Debtors</I>, in accounting for this debt conversion. The difference
between the fair value of the pre-funded warrants issued and the carrying value of the debt settled in the transaction was recognized
as a capital contribution of $1,862,735 in the Statement of Stockholders&#8217; Equity.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
remaining outstanding principal of the note of $3.0 million and all accrued and unpaid interest are due and payable on August 8, 2025,
or 120 days following written demand made by WFIA during the first five business days of a calendar quarter. WFIA has not demanded payment
on the note. The Company may prepay the note, in whole or in part, without premium or penalty; provided, that no amount repaid may be
reborrowed.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of September 30, 2023 and December 31, 2022, $3.0 million and $5.0 million, respectively, of principal were outstanding on the note.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the three months ended September 30, 2023, the Company recognized $237,500 of interest expense relating to the note. During the nine
months ended September 30, 2023, the Company recognized $677,500 of interest expense relating to the note. All interest expense relating
to the note is included in accrued expenses on the consolidated balance sheet.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(8)
Stockholders&#8217; Equity</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has authorized 240,000,000 shares of $0.0001 par value common stock and 10,000,000 shares of $0.0001 par value preferred stock
at September 30, 2023, and December 31, 2022, of which 868,940 and 565,470 shares of common stock were issued and outstanding as
of September 30, 2023 and December 31, 2022, respectively. The Company has not issued any shares of preferred stock.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
holders of common stock are entitled to one vote for each share of common stock. In the event of any voluntary or involuntary liquidation,
dissolution or winding up of the Company, after the payment or provision for payment of all debts and liabilities of the Company, the
holders of common stock shall be entitled to share in the remaining assets of the Company available for distribution, if any. Holders
of the shares of common stock are entitled to dividends when, as and if declared by the Board of Directors.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(9)
Sale of Securities</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Private
Placement</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 11, 2023, the Company entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the
market under Nasdaq rules 91,158 shares of its common stock at a purchase price per share of $10.97, resulting in gross proceeds
to the Company of approximately $1.0 million. Peter Werth, a member of the Company&#8217;s Board of Directors, is the manager of WFIA.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Public
Offering</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 11, 2023, the Company entered into a Securities Purchase Agreement with an institutional investor (September 2023 Offering)
pursuant to which the Company issued 86,000
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of its common stock at a combined price
of $11.55
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per share and accompanying Series A and Series
B warrants and pre-funded warrants (Pre-Funded Warrants) to purchase up to an aggregate of 260,261
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of its common stock at a combined
purchase price of $11.55
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per Pre-Funded Warrant, and accompanying Series
A and Series B warrants, which represents the public offering price for the common stock less the $0.002
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per share exercise price per share for each
Pre-Funded Warrant. The September 2023 Offering
closed on September 13, 2023. The Pre-Funded Warrants are exercisable at any time after the date of issuance and have no expiration date.
The holder of Pre-Funded Warrants may not exercise the warrants if the holder, together with its affiliates, would beneficially own more
than 4.99% (or, at the election of the holder, 9.99%) of the number of shares of common stock outstanding immediately after giving effect
to such exercise.</FONT> <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The September 2023 Offering
resulted in gross proceeds to the Company of $3,999,480</FONT>
<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">before deducting $688,929
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">of placement agent fees and other offering expenses.
See Note 10 for a description of Series A and Series B warrants issued in the September 2023 Offering.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Conversion
of Related Party Note </FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
September 8, 2023, the Company issued WFIA Pre-Funded Warrants to purchase 341,912
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of the Company&#8217;s common stock as
part of the Note Conversion Agreement, as described in Note 7. The
WFIA Pre-Funded Warrants have no expiration date and are exercisable immediately at an exercise price of </FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$0.002
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per
share, to the extent that after giving effect to such exercise, WFIA and its affiliates would beneficially own, for purposes of Section
13(d) of the Exchange Act, no more than 19.99% of the outstanding shares of common stock of the Company.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">Purchase
Agreement with Lincoln Park</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
April 2023, the Company entered into a purchase agreement (LP Purchase Agreement) and a registration rights agreement (Registration Rights
Agreement) with Lincoln Park Capital Fund, LLC (Lincoln Park). Pursuant to the terms of the LP Purchase Agreement, Lincoln Park has agreed
to purchase from the Company up to $12
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">million of the Company&#8217;s common stock subject
to certain limitations and satisfaction of the conditions set forth in the LP Purchase Agreement. Pursuant to the terms of the Registration
Rights Agreement, the Company filed with the SEC a registration statement to register for resale under the Securities Act 225,000
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock that have been or may
be issued to Lincoln Park under the LP Purchase Agreement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Pursuant
to the terms of the LP Purchase Agreement, at the time the Company signed the LP Purchase Agreement and the Registration Rights Agreement,
the Company issued 18,402
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock to Lincoln Park as
consideration for its commitment to purchase shares of common stock under the LP Purchase Agreement. The commitment shares were valued
at $400,409
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">and recorded as an addition to equity for the
issuance of the common stock and treated as a reduction to equity as a cost of capital to be raised under the LP Purchase Agreement.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the quarter ended September 30, 2023, the Company sold 12,000 shares of common stock under the LP Purchase Agreement, for net proceeds
of $196,167. During the nine months ended September 30, 2023, the Company sold 25,500 shares of common stock under the LP Purchase Agreement,
for net proceeds of $450,427.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="text-decoration: underline">At
the Market Offering</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
January 2023, the Company entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright &amp; Co., LLC (HCW)
pursuant to which the Company may issue and sell, from time to time, shares of the Company&#8217;s common stock having an aggregate offering
price of up to $4.97 million in at-the-market offerings sales. HCW will act as sales agent and will be paid a 3% commission on each sale
under the ATM Agreement. The Company&#8217;s common stock will be sold at prevailing market prices at the time of the sale, and, as a
result, prices will vary. During the quarter ended September 30, 2023, the Company sold 76,943 shares of common stock under the ATM
Agreement, for net proceeds of $1,595,429. During the nine months ended September 30, 2023, the Company sold 82,410 shares of common
stock under the ATM agreement, for net proceeds of $1,696,407.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(10)
<FONT>Common Stock Purchase Warrants</FONT></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition to the 346,261
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock and Pre-Funded Warrants
issued in the September 2023 Offering, the Company issued Series A warrants to purchase up to 346,261
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock and Series B warrants
to purchase up to 173,131
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">shares of common stock. The Series A and
Series B warrants have an exercise price of $11.55
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">per share and are exercisable on the effective
date of stockholder approval of the shares issuable pursuant to the warrants. The Series A warrants have a five</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">-year
term and the Series B warrants have a two</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">-year
term from the initial exercise date.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company evaluated the Pre-Funded Warrants for liability or equity classification in accordance with the provisions of ASC Topic 480,
<I>Distinguishing Liabilities from Equity</I>, and ASC Topic 815, <I>Derivatives and Hedging</I>, and determined that equity treatment
was appropriate. The Company valued the Pre-Funded Warrants to purchase 260,260 shares of common stock based on their issuance date
fair value of $3,006,008. As of September 30, 2023, none of the Pre-Funded Warrants had been exercised.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
connection with the September 2023 Offering, the Company issued placement agent warrants to purchase up to 17,313 shares of common stock.
The placement agent warrants have an exercise price of $11.55 per share. These warrants have a five-year term ending September 11, 2028.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Series A, Series B and placement agent warrants issued in the September 2023 Offering were valued using a Black-Scholes model with a
risk-free rate of 4.5%-5.3%, the respective terms of five and two years, and a volatility of 1.29-1.32. The estimated volatility of the
Company&#8217;s common stock at the date of measurement is based on an average historical stock price volatility of comparable public
companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as
the Company does not have sufficient trading history for its common stock. The risk-free rate is based on the expected term of the warrants
based on the constant maturity of U.S. Treasury securities with similar maturities as of the date of grant. The expected term has been
estimated using the contractual term of the warrants.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
following table summarizes the Company&#8217;s outstanding common stock purchase warrants as of September 30, 2023:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule
of Warrants and Rights Outstanding</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Number of</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; text-align: center">Fair Value</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Price</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Total</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 44%; text-align: left">December 2021 Initial Public Offering</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">239,584</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">120.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">95.3997</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">22,856,242</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">December 2021 Underwriter Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">10,417</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">150.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">92.7969</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">966,665</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">September 2023 WFIA Pre-funded Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">341,912</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">0.0001</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">16.9999</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,812,500</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">September 2023 Public Offering Pre-funded Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">260,261</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">0.0001</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">11.5460</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,006,008</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">September 2023 Public Offering Series A Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">346,261</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">11.60</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">10.7999</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,739,612</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">September 2023 Public Offering Series B Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">173,131</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">11.60</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">8.3999</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,454,294</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">September 2023 Placement Agent Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">17,313</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">14.40</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">10.6000</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">183,518</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Balance- September 30, 2023</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">1,388,879</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">38,018,839</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company has accounted for these warrants as equity-classified instruments under ASU 2020-06, <I>Accounting for Convertible Instruments
and Contracts in an Entity&#8217;s Own Equity, </I>as they are indexed to the Company&#8217;s common stock, and they meet all other conditions
as defined in ASU 2020-06 for equity classification. The gross proceeds of the September 2023 public offering was allocated to the common
stock/pre-funded warrants and common stock purchase warrants using the relative fair value method shown as follows. Fair value of the
warrants was recorded to Additional Paid-in-Capital on the Company&#8217;s balance sheet.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Fair
Value of the Warrants to Additional Paid in Capital</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 90%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 55%; text-align: left">Common Stock and Pre-Funded Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 11%; text-align: right">42.7</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">%</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 11%; text-align: right">1,707,778</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Series A, B and Placement Agent Warrants</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">2,291,702</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Total</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(11)
Stock-Based Compensation</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
September 2021, the Company&#8217;s board of directors and stockholders adopted the 2021 Equity Incentive Plan (2021 Plan), which provides
for the grant of incentive stock options and non-qualified stock options to purchase shares of the Company&#8217;s common stock, stock
appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance units,
incentive bonus awards, other stock-based awards and other cash-based awards. No awards may be made under the 2021 Plan on or after September
24, 2031, but the 2021 Plan will continue thereafter while previously granted awards remain outstanding.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
maximum number of shares of common stock available for issuance in connection with options and other awards granted under the 2021 Plan
is 139,116 and as of September 30, 2023, 66,678 shares of common stock were available for issuance under the 2021 Plan. The number
of shares of common stock available for issuance under the 2021 Plan will automatically increase on January 1st of each year until the
expiration of the 2021 Plan, in an amount equal to 5% percent of the total number of shares of our common stock outstanding on December
31st of the preceding calendar year, on a fully diluted basis, unless the board of directors takes action prior thereto to provide that
there will not be an increase in the share reserve for such year or that the increase in the share reserve for such year will be of a
lesser number of shares of common stock than would otherwise occur. The shares of common stock underlying any awards that are forfeited,
cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise
terminated by the Company under the 2021 Plan will be added back to the shares of common stock available for issuance under the 2021
Plan.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company recorded stock-based compensation expense of $658,105 during the nine months ended September 30, 2023 and $594,363 during the
nine months ended September 30, 2022. The Company recorded stock-based compensation expense of $236,251 during the three months ended
September 30, 2023 and $205,656 during the three months ended September 30, 2022, all relating to options issued during 2021, 2022 and
2023. As of September 30, 2023 and December 31, 2022, there was $2,133,614 and $2,637,895, respectively, of unrecognized compensation
cost related to nonvested share-based compensation arrangements granted under the 2021 Plan, which is expected to be recognized over
the next one to four years.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
summary of option activity under the Plan during the three and nine months ended September 30, 2023 is as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Summary of Option Activity</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Term (years)</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 10%; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Granted</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; text-align: right">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;35.00</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">9.92</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Exercised</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Granted</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">6,388</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company&#8217;s stock options issued qualify for equity accounting treatment under ASC 718, <I>Compensation- Stock Compensation,</I>
and are measured at fair value as of their grant date accordingly. The fair value of the options were estimated using a Black-Scholes
model. The assumptions that the Company used to estimate the grant-date fair value of stock options granted to employees during the nine-month
period ending September 30, 2023, were as follows, shown on a weighted average basis:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule
of Fair Value Assumption</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 60%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Expected dividend yield</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Risk-Free
Interest Rate</I>: The Company based the risk-free interest rate over the expected term of the options based on the constant maturity
of U.S. Treasury securities with similar maturities as of the date of grant.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Term:</I> The expected term represents the period that the options granted are expected to be outstanding and is determined using the
simplified method (based on the mid-point between the vesting dates and the end of the contractual term.)</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Volatility</I>: The Company uses an average historical stock price volatility of comparable public companies within the biotechnology
and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient
trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information
regarding volatility of its own stock price becomes available.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><I>Expected
Dividend Yield</I>: The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected
dividend yield was zero.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
grant-date fair value of options granted during the three months ended September 30, 2023, ranged from $10.20
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">to $12.80</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">,
and the grant date fair value of the options granted during the nine months ended September 30, 2023, ranged from ranged from $10.20
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">to $30.60.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair
value of the Company&#8217;s common stock. The fair value per share of common stock was $14.20
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">as of September 30, 2023, and $20.00
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">as of December 31, 2022, based upon the closing
price of our common stock on the Nasdaq Capital Market on those dates.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(12)
Income Taxes</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Cingulate
Inc. is taxed as a C corporation under the Internal Revenue Code. Cingulate Inc. records deferred income taxes to reflect the impact
of temporary differences between the recorded amounts of assets and liabilities for financial reporting purposes and such amounts as
measured by tax laws and regulations. CTx is a wholly-owned disregarded entity of Cingulate Inc., and all of the activity for CTx, along
with its wholly-owned subsidiary Cingulate Works Inc., is included in the calculation of the current and deferred tax assets and liabilities
for Cingulate Inc. No deferred income tax benefit or expense was recorded for the three-month periods ended September 30, 2023, and 2022
or the nine-month periods ended September 30, 2023 and 2022, for federal or state income taxes.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Income
tax expense differed from the expected expense computed by applying the U.S. Federal income tax rate as follows:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">&#160;<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule
of Effective Income Tax Rate Reconciliation</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 95%">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; white-space: nowrap; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; white-space: nowrap; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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September 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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September 30, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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September 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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September 30, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 32%; text-align: left">Federal income tax benefit at statutory rate</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 13%; text-align: right">(1,255,601</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 13%; text-align: right">(845,722</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 1%; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(222,707</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(917,994</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(719,896</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Permanent differences</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,157</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">14,457</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">11,920</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">2,218,188</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">1,132,895</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,089,875</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">3,572,189</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(620,630</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(620,630</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Evaluating
the need for, and amount of, a valuation allowance for deferred tax assets often requires significant judgment and extensive analysis
of all available evidence on a jurisdiction-by-jurisdiction basis. Such judgments require the Company to interpret existing tax law and
other published guidance as applied to its circumstances. As part of this assessment, the Company considers both positive and negative
evidence about its profitability and tax situation. A valuation allowance is provided if, based on available evidence, it is more likely
than not that all or some portion of a deferred tax asset will not be realized. The Company determined that it was more likely than not
that it would not realize its deferred tax assets, based on historical levels of income and future forecasts of taxable income, among
other items. The Company recorded a valuation allowance of its net deferred tax assets totaling $10,988,821 as of September 30, 2023,
and $5,580,595 at December 31, 2022, which was recorded as a component of income tax expense on the accompanying consolidated statements
of operations and other comprehensive loss.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company files income tax returns in the U.S. federal and various state jurisdictions. The Company is not subject to U.S. federal and
state income tax examinations by tax authorities for years before 2018.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
Company follows the provisions of FASB ASC 740, <I>Income Taxes</I>, to evaluate uncertain tax positions. This topic prescribes a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be
taken in a tax return. The Company has not identified any material uncertain tax positions requiring recognition in the consolidated
financial statements as of September 30, 2023 or December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule of Deferred Tax Assets and Liabilities</FONT></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"></FONT></P>

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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Deferred income tax assets:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Current:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; width: 52%; text-align: left">Research and development costs</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">59,018</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Non-current:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Net operating losses</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Research and development costs</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Research and development tax credit</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Unvested stock options</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">204,380</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">92,417</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Right-of-use assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 30pt; text-align: left">Gross deferred income tax assets</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">11,596,891</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">5,906,396</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 30pt; text-align: left">Less: valuation allowance</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(5,580,595</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 40pt; text-align: left">Net deferred income tax asset</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">325,801</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Deferred income tax liabilities:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Current:</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; text-align: left">Accrual to cash</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">(11,228</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">Non-current</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 20pt; text-align: left">Property and equipment</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(608,070</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(314,573</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 30pt; text-align: left">Gross deferred income tax liabilities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: right">(325,801</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">)</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 30pt; text-align: left">Net deferred tax asset (liability)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">-</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B></B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(13)
Net Loss Per Share </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Basic
net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of common shares
and pre-funded warrants outstanding during the period. The pre-funded warrants are included in the calculation of the weighted-average
number of shares outstanding because their exercise requires only nominal consideration for the delivery of shares. The following table
sets forth the computation of the basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule
of Net  Loss Per Share Basic and Diluted</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%">
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
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    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Three Months Ended<BR>
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 September 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">Nine Months Ended<BR>
 September 30, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
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    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: right">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Weighted average shares outstanding</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">Net loss per share, basic and diluted</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">$</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">(6.05</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">)</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
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  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Potentially
dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows
for the three and nine-month periods ended September 30, 2023 and September 30, 2022:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><FONT STYLE="display: none">Schedule of Potentially Dilutive Securities</FONT></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 85%">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">September 30, 2023</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD COLSPAN="2" STYLE="font: bold 10pt Times New Roman, Times, Serif; border-bottom: Black 1.5pt solid; text-align: center">September 30, 2022</TD><TD STYLE="font: bold 10pt Times New Roman, Times, Serif">&#160;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 64%; text-align: left">Stock options issued under the 2021 Equity Incentive Plan</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 2%">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: White">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">Common stock purchase warrants outstanding</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt">Total</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">859,351</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#160;</TD>
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  <TR STYLE="font: 10pt Times New Roman, Times, Serif; display: none; vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-left: 10pt; padding-bottom: 2.5pt">Antidilutive securities</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">859,351</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt">&#160;</TD>
    <TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: left">&#160;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; border-bottom: Black 2.5pt double; text-align: right">294,190</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 2.5pt; text-align: left">&#160;</TD></TR>
</TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(14)
License Agreement</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">CTx
has a licensing agreement with a company related to the patents and licensed know-how for use in the development of CTx-1301, CTx-1302,
and CTx-2103. Payments are to be made upon the occurrence of the following milestone events:</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment upon dosing of first patient in a Phase 3 Clinical Trial for each product
                                            in the field, payable on a per product basis.</FONT></TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment upon licensee filing of new drug application for each product in the field,
                                            payable on a per product basis.</FONT></TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment for CTx-1301 and CTx-1302 and $500,000 Milestone payment for CTx-2103 upon
                                            receipt of first marketing approval from the FDA, payable on a per product basis.</FONT></TD></TR>
<TR STYLE="font: 10pt Times New Roman, Times, Serif; vertical-align: top">
<TD STYLE="font: 10pt Times New Roman, Times, Serif"></TD><TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</TD><TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">$250,000
                                            Milestone payment for CTx-2103 upon receipt of first marketing approval from the EMA (European
                                            Medicines Agency)</FONT></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
of December 31, 2022, the $250,000 milestone for CTx-1301 relating to the dosing of first patient in a Phase 3 Clinical Trial was accrued
as management deemed the milestone probable of occurring. In early 2023, the Company paid this amount as the first patient in a CTx-1301
Phase 3 Clinical Trial was dosed. The Company has not recorded any expense relating to the other milestones for any other product as
it has not deemed them probable of occurring as of September 30, 2023.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(15)
Related Party Transactions</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>&#160;</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
general counsel of the Company is a partner with a law firm providing office facilities space that is leased by the Company. Rental expense
incurred by the Company to the law firm was $27,000 for both the nine months ended September 30, 2023 and 2022 and $9,000 for both the
three months ended September 30, 2023 and 2022, which approximates fair value. As of September 30, 2023 and December 31, 2022, the Company
had no outstanding amounts payable under this lease.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
member of the Company&#8217;s Board of Directors, Peter Werth, is the manager of WFIA, the entity which provided $8.0 million in debt
financing to the Company, $5.0 million of which was converted to equity in September 2023, as described in Note 7. The remaining principal
balance of $3.0 million was outstanding as of September 30, 2023 and the initial principal balance of $5.0 million was outstanding as
of December 31, 2022. Interest expense of $237,500 and $104,838 was recognized during the three months ended September 30, 2023 and September
30, 2022, respectively. Interest expense of $677,500 and $104,838 was recognized during the nine months ended September 30, 2023 and
September 30, 2022, respectively. $157,339 and $292,339 of accrued interest relating to this note was outstanding as of September 30,
2023 and December 31, 2022.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">On
August 11, 2023, the Company entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the
market under Nasdaq rules, 91,158 shares of its common stock at a purchase price per share of $10.97, resulting in gross proceeds
to the Company of approximately $1.0 million.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>(16)
Subsequent Events</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management
evaluated events that occurred subsequent to September 30, 2023, through November 13, 2023, which is the date the interim financial statements
were issued.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><B>(17) Reverse Stock Split</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify">On November 30, 2023, the Company
completed a one-for-twenty reverse stock split (the &#8220;Reverse Stock Split&#8221;), which reduced the number of shares of the Company&#8217;s
common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares
of the Company&#8217;s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company&#8217;s common
stock remained unchanged at $0.0001
per share. No fractional shares were issued in connection with the Reverse Stock Split. Except where disclosed, all amounts
related to number of shares and per share amounts have been retroactively restated in these financial statements.</P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>1,375,000</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B> Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>3,750,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Series
A Warrants to Purchase up to 3,750,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>1,875,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Series
B Warrants to Purchase up to 1,875,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>2,375,000 </B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Pre-Funded
Warrants to Purchase up to 2,375,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>8,000,000</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>
Shares of Common Stock Underlying the Series A Warrants, Series B Warrants and Pre-Funded Warrants </B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>150,000
</B></FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Placement Agent Warrants to Purchase up to
150,000 Shares of Common Stock</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>150,000</B><B> Shares of Common
Stock Underlying the Placement Agent Warrants</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="form424b4_016.jpg" ALT="" STYLE="height: 59px; width: 173px"></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 12pt"><B>PROSPECTUS</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#160;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">February 2<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">,
</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">2024</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>

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<DOCUMENT>
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end
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<DOCUMENT>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
