<SEC-DOCUMENT>0001213900-22-072414.txt : 20221114
<SEC-HEADER>0001213900-22-072414.hdr.sgml : 20221114
<ACCEPTANCE-DATETIME>20221114171831
ACCESSION NUMBER:		0001213900-22-072414
CONFORMED SUBMISSION TYPE:	S-8
PUBLIC DOCUMENT COUNT:		20
REFERENCES 429:			333-265843
FILED AS OF DATE:		20221114
DATE AS OF CHANGE:		20221114
EFFECTIVENESS DATE:		20221114

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Blue Water Vaccines Inc.
		CENTRAL INDEX KEY:			0001782107
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		S-8
		SEC ACT:		1933 Act
		SEC FILE NUMBER:	333-268357
		FILM NUMBER:		221387729

	BUSINESS ADDRESS:	
		STREET 1:		2041 COURTLAND AVENUE
		CITY:			CINCINNATI
		STATE:			OH
		ZIP:			45212
		BUSINESS PHONE:		646-303-0737

	MAIL ADDRESS:	
		STREET 1:		2041 COURTLAND AVENUE
		CITY:			CINCINNATI
		STATE:			OH
		ZIP:			45212
</SEC-HEADER>
<DOCUMENT>
<TYPE>S-8
<SEQUENCE>1
<FILENAME>ea168413-s8_bluewater.htm
<DESCRIPTION>REGISTRATION STATEMENT
<TEXT>
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<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>As filed with the Securities and Exchange Commission on November 14,
2022</B></P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Registration No. 333-______________</B></P>

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<!-- Field: Rule-Page --><DIV STYLE="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>UNITED STATES</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>SECURITIES AND
EXCHANGE COMMISSION</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></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: center"><FONT STYLE="font-size: 18pt"><B>FORM S-8</B></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: center"><B>REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933</B></P>

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

<P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>Blue Water Vaccines
Inc.</B></FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified in charter)</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</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="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>Delaware</B></TD>
    <TD STYLE="width: 2%; padding-bottom: 1.75pt; font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>81-2262816</B></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="font-size: 10pt; text-align: center">(State or Other Jurisdiction of<BR>
Incorporation or Organization)</TD>
    <TD STYLE="font-size: 10pt; text-align: center">&nbsp;</TD>
    <TD>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(IRS Employer</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Identification No.)</P></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 49%; border-bottom: black 1.5pt solid">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>201 E. Fifth Street, Suite 1900</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Cincinnati, OH</B></P></TD>
    <TD STYLE="width: 2%; padding-bottom: 1.75pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; text-align: center"><B>45202</B></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: center">(Address of Principal Executive Offices)</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">(Zip Code)</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
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    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Blue Water Vaccines Inc. 2019 Equity
    Incentive Plan</B></P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Blue Water Vaccines Inc. 2022 Equity
    Incentive Plan</B></P></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="font-size: 10pt; text-align: center">(Full Title of the Plan)</TD></TR>
  </TABLE>
<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-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Joseph Hernandez</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>201 E. Fifth Street, Suite 1900</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><U>Cincinnati, OH 45202</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Name and Address of Agent For Service)</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><U>(513) 620-4101</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Telephone Number, Including Area Code of Agent
For Service.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Ellenoff Grossman &amp; Schole LLP</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>1345 Avenue of the Americas, 11th Floor</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>New York, New York 10105</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Telephone: (212) 370-1300</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Facsimile: (212) 370-7889</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of &ldquo;large accelerated filer,&rdquo; &ldquo;accelerated filer,&rdquo; &ldquo;smaller reporting company&rdquo;
and &ldquo;emerging growth company&rdquo; in Rule 12b-2 of the Exchange Act. (Check one):</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 29%; padding-right: 0.65pt">Large accelerated filer</TD>
    <TD STYLE="width: 15%; padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></TD>
    <TD STYLE="width: 1%; padding-right: 1.05pt">&nbsp;</TD>
    <TD STYLE="width: 40%; padding-right: 0.65pt">Accelerated filer</TD>
    <TD STYLE="width: 15%; padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="padding-right: 0.65pt">Non-accelerated filer</TD>
    <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD>
    <TD STYLE="padding-right: 1.05pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.65pt">Smaller reporting company</TD>
    <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD COLSPAN="2" STYLE="padding-right: 0.85pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.65pt">&nbsp;</TD>
    <TD STYLE="padding-right: 0.65pt">Emerging growth company</TD>
    <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. <FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></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: justify">&nbsp;</P>

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



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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Blue Water Vaccines Inc. (the &ldquo;Registrant&rdquo;
or the &ldquo;Company&rdquo;) is filing this registration statement on Form S-8 under the Company&rsquo;s 2019 Equity Incentive Plan (the
&ldquo;2019 Plan&rdquo;) and the 2022 Equity Incentive Plan (the &ldquo;2022 Plan&rdquo;) to (i) register 1,000,000 shares of our common
stock, par value $0.00001 per share (the &ldquo;Common Stock&rdquo;), to be issued pursuant to the 2022 Plan, as described in more detail
herein, including registering for resale pursuant to a reoffer prospectus certain securities to be issued to our officers and directors
upon exercise of outstanding options or vesting of outstanding restricted stock units as described below, and (ii) serve as a post-effective
amendment, pursuant to Rule 429 under the Securities Act, to our Registration Statement on Form S-8 (File No. 333-265843) filed with the
Securities and Exchange Commission on June 27, 2022 (the &ldquo;Prior Registration Statement&rdquo;).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to General Instruction E to Form S-8,
the contents of the Prior Registration Statement are incorporated herein by reference, except to the extent supplemented, amended or superseded
by the information set forth in this registration statement on Form S-8.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This Registration Statement includes, pursuant
to General Instruction E to Form S-8, a re-offer prospectus in Part I (the &ldquo;Reoffer Prospectus&rdquo;). The Reoffer Prospectus may
be utilized for reofferings and resales by certain executive officers and directors listed in the Reoffer Prospectus who may be deemed
&ldquo;affiliates&rdquo; of the Company on a continuous or a delayed basis in the future of up to 2,600,000 Common Shares to be issued
under the 2019 and the 2022 Plan. These shares constitute &ldquo;control securities&rdquo; or &ldquo;restricted securities&rdquo; which
have been issued prior to or issuable after the filing of this Registration Statement. The Reoffer Prospectus does not contain all of
the information included in the Registration Statement, certain items of which are contained in schedules and exhibits to the Registration
Statement, as permitted by the rules and regulations of the SEC. Statements contained in the Reoffer Prospectus as to the contents of
any agreement, instrument or other document referred to are not necessarily complete. With respect to each such agreement, instrument
or other document filed as an exhibit to the Registration Statement, we refer you to the exhibit for a more complete description of the
matter involved, and each such statement shall be deemed qualified in its entirety by this reference.&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">As specified in General Instruction
C of Form S-8, until such time as we meet the registrant requirements for use of Form S-3, the number of shares of Common Stock to be
offered by means of the Reoffer Prospectus, by each of the selling security holders, and any other person with whom he or she is acting
in concert for the purpose of selling our shares of Common Stock, may not exceed, during any three month period, the amount specified
in Rule&nbsp;144(e)&nbsp;of the&nbsp;Securities Act.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REOFFER PROSPECTUS</B></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: center; background-color: white"><B>Blue Water Vaccines
Inc.</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left; background-color: white"><B>Up to 2,600,000 shares
of Common Stock under the 2019 Equity Incentive Plan and 2022 Equity Incentive Plan</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">This
prospectus relates to the resale of up to 2,600,000 shares (the &ldquo;Shares&rdquo;) of common stock, par value $0.00001 per share (the
&ldquo;Common Stock&rdquo;), of Blue Water Vaccines Inc., a Delaware corporation (the &ldquo;Company&rdquo;, &ldquo;us&rdquo;, &ldquo;our&rdquo;
or &ldquo;we&rdquo;), which may be offered and sold from time to time by certain stockholders of the Company (the &ldquo;Selling Stockholders&rdquo;)
who have acquired or will acquire such Shares in connection with the exercise of stock options granted, and with stock or other awards
made, and with the purchase of stock under, the 2019 Plan or the 2022 Plan. The 2019 Plan and the 2022 Plan are intended to provide incentives
which will attract, retain, and motivate highly competent persons such as officers, employees, directors, and consultants to our Company
by providing them opportunities to acquire shares of our Common Stock. Additionally, the 2019 Plan and the 2022 Plan are intended to assist
in further aligning the interests of our officers, employees, directors and consultants to those of the Company&rsquo;s other stockholders.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; background-color: white">The persons who are
issued such Shares may include our directors, officers, employees and consultants, certain of whom may be considered our
&ldquo;affiliates&rdquo;. Such persons may, but are not required to, sell the Shares they acquire pursuant to this prospectus. If
any additional awards are issued to or Shares are purchased by affiliates under the 2019 Plan or the 2022 Plan, we will file with
the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) an update to this prospectus naming such person as a selling
shareholder and indicating the number of shares such person is offering pursuant to the prospectus. See &ldquo;Selling
Stockholders&rdquo; on page 110 of this prospectus. Our Common Stock is listed on The Nasdaq Capital Market under the symbol
&ldquo;BWV.&rdquo; On November 9, 2022, the closing price of the Common Stock on The Nasdaq Capital Market was $0.9199 per share.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our shares of common stock have experienced extreme
volatility in market prices and trading volume since listing. From February&nbsp;18, 2022 (the date our shares were initially listed on
Nasdaq) to the date hereof, the market price of our common stock has fluctuated from an intra-day low on Nasdaq of $0.91 on November 9,
2022 to an intra-day high of $90.90 per share on February&nbsp;22, 2022. By comparison, our initial public offering, which closed on February&nbsp;23,
2022, was conducted at $9.00 per share. During this time, we have made various announcements regarding certain research developments and
partnerships for our vaccine candidates. Notwithstanding the foregoing, since our initial public offering on February&nbsp;18, 2022, there
were no material recent publicly disclosed changes in the financial condition or results of operations of the Company, such as our earnings
or revenue, that are consistent with or related to the changes in our stock price. The trading price of our common stock has been, and
may continue to be, subject to wide price fluctuations in response to various factors, many of which are beyond our control, including
those described under the heading &ldquo;Risk Factors&rdquo; beginning on page 66 of this prospectus.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">We
will not receive any of the proceeds from sales of the Shares by any of the Selling Stockholders. The Shares may be offered from time
to time by any or all of the Selling Stockholders through ordinary brokerage transactions, in negotiated transactions or in other transactions,
at such prices as such Selling Stockholder may determine, which may relate to market prices prevailing at the time of sale or be a negotiated
price. See &ldquo;Plan of Distribution.&rdquo; Sales may be made through brokers or to dealers, who are expected to receive customary
commissions or discounts. We are paying all expenses of registration incurred in connection with this offering but the Selling Stockholders
will pay all brokerage commissions and other selling expenses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">The
Selling Stockholders and participating brokers and dealers may be deemed to be &ldquo;underwriters&rdquo; within the meaning of the Securities
Act, in which event any profit on the sale of shares of those Selling Stockholders and any commissions or discounts received by those
brokers or dealers may be deemed to be underwriting compensation under the Securities Act.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; background-color: white">SEE &ldquo;RISK
FACTORS&rdquo; BEGINNING ON PAGE 66 OF THIS PROSPECTUS FOR A DISCUSSION OF CERTAIN RISKS AND OTHER FACTORS THAT YOU SHOULD CONSIDER
BEFORE PURCHASING OUR COMMON STOCK.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">Neither
the Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is
truthful or complete. Any representation to the contrary is a criminal offense.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">The date of this prospectus
is November 14, 2022.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</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">&nbsp;</P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom; background-color: white">
    <TD STYLE="width: 90%">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center">Page No</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_001">Where You Can Find More Information</A></TD>
    <TD STYLE="text-align: center">ii</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD><A HREF="#a_002">Prospectus Summary</A></TD>
    <TD STYLE="text-align: center">1</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_003">Incorporation of Certain Documents By Reference</A></TD>
    <TD STYLE="text-align: center">8</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD><A HREF="#a_011">Note on Forward Looking Statements</A></TD>
    <TD STYLE="text-align: center">9</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_004">The Company</A></TD>
    <TD STYLE="text-align: center">11</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD><A HREF="#a_005">Risk Factors</A></TD>
    <TD STYLE="text-align: center">66</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_006">Selling Stockholders</A></TD>
    <TD STYLE="text-align: center">110</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD><A HREF="#a_007">Use of Proceeds</A></TD>
    <TD STYLE="text-align: center">111</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_008">Plan of Distribution</A></TD>
    <TD STYLE="text-align: center">111</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD><A HREF="#a_009">Legal Matters</A></TD>
    <TD STYLE="text-align: center">112</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD><A HREF="#a_010">Experts</A></TD>
    <TD STYLE="text-align: center">112</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">You should rely only on the
information contained in or incorporated by reference into this prospectus or any prospectus supplement. We have not authorized any person
to give any information or to make any representations other than those contained or incorporated by reference in this prospectus, and,
if given or made, you must not rely upon such information or representations as having been authorized. This prospectus does not constitute
an offer to sell or the solicitation of an offer to buy any securities other than our shares of Common Stock described in this prospectus
or an offer to sell or the solicitation to buy such securities in any circumstances in which such offer or solicitation is unlawful. You
should not assume that the information we have included in this prospectus is accurate as of any date other than the date of this prospectus
or that any information we have incorporated by reference is accurate as of any date other than the date of the document incorporated
by reference regardless of the time of delivery of this prospectus or of any securities registered hereunder.</P>



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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="a_001"></A>WHERE YOU CAN FIND
MORE INFORMATION</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">The
Company is subject to the information requirements of the Securities Exchange Act of 1934, as amended (the &ldquo;Exchange Act&rdquo;),
and, in accordance therewith, files reports, proxy statements and other information with the Commission. We are required to file electronic
versions of those materials with the Commission through the Commission&rsquo;s EDGAR system. The Commission maintains an Internet site
at http://www.sec.gov, which contains reports, proxy and information statements and other information regarding registrants that file
electronically with the Commission. You can read and copy the reports, proxy statements and other information filed by the Company with
the Commission at such Internet site.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">This
prospectus constitutes part of a Registration Statement on Form S-8 filed on the date hereof (herein, together with all amendments and
exhibits, referred to as the &ldquo;Registration Statement&rdquo;) by the Company with the Commission under the Securities Act. This prospectus
does not contain all of the information set forth in the Registration Statement, certain parts of which we have omitted, in accordance
with the rules and regulations of the Commission. You should refer to the full Registration Statement for further information with respect
to the Company and our Common Stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">Statements
contained herein concerning the provisions of any contract, agreement or other document are not necessarily complete, and in each instance
reference is made to the copy of such contract, agreement or other document filed as an exhibit to the Registration Statement or otherwise
filed with the Commission. Each such statement is qualified in its entirety by such reference. Copies of the Registration Statement together
with exhibits may be inspected at the offices of the Commission as indicated above without charge and copies thereof may be obtained therefrom
upon payment of a prescribed fee.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">No
person is authorized to give any information or to make any representations, other than those contained in this prospectus, in connection
with the offering described herein, and, if given or made, such information or representations must not be relied upon as having been
authorized by the Company or any Selling Stockholder. This prospectus does not constitute an offer to sell, or a solicitation of an offer
to buy, nor shall there be any sale of these securities by any person in any jurisdiction in which it is unlawful for such person to make
such offer, solicitation or sale. Neither the delivery of this prospectus nor any sale made hereunder shall under any circumstances create
an implication that the information contained herein is correct as of any time subsequent to the date hereto.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"></P>

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


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center"><B><A NAME="a_002"></A>PROSPECTUS SUMMARY</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: left"><I>The Commission allows us to &ldquo;incorporate
by reference&rdquo; certain information that we file with the Commission, which means that we can disclose important information
to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus, and
information that we file later with the Commission will update automatically, supplement and/or supersede the information disclosed in
this prospectus. Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall
be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or
in any other document that also is or is deemed to be incorporated by reference in this prospectus modifies or supersedes such statement.
Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You should read the following summary together with the more detailed information regarding our company, our Common Stock and our financial
statements and notes to those statements incorporated herein by reference.</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are a biotechnology company focused on the research
and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique molecular
properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines. Our lead influenza
(flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties that enables
the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and long-term immunity.
We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines to improve both health
outcomes and quality of life globally.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
pipeline includes novel vaccine candidates exclusively licensed from renowned research institutions. We seek to develop vaccines that
provide long-lasting immunity to harmful viral and bacterial pathogens that cause infections in patient populations with high unmet needs.
Our exclusive license agreements include patented influenza epitopes of limited variability, or ELV, identified through a proprietary
computational research and discovery process, discovered by Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. Our collaborators
are pioneers in vaccine discovery and development. We are exploring the development of these influenza ELV&rsquo;s utilizing our Norovirus
shell and protrusion (S&amp;P) nanoparticle vaccine platform licensed from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC.&nbsp;We
are also utilizing our platform to develop a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus.</FONT>
We are also utilizing this platform to assess the potential to create a novel monkeypox vaccine candidate. <FONT STYLE="font-family: Times New Roman, Times, Serif">Our
exclusively licensed <I>S. pneumoniae</I> vaccine candidate is from St. Jude Children&rsquo;s Research Hospital. The vaccine is designed
to prevent harmful middle-ear infections in children as well as to prevent pneumococcal pneumonia, and is being developed for intranasal
delivery, well suited for both pediatric and adult patients. We leverage the expertise of our collaborators to pursue the discovery and
development of vaccines for these diseases, which are high unmet needs globally.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we have expertise in identifying business
development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion and the
ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There is
potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccination has been used as an effective
method of protecting individuals against harmful diseases by utilizing the body&rsquo;s natural defense system to develop resistance
or immunity to infections (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>).
The body&rsquo;s immune system naturally creates antibodies and cell  -mediated immunity to defend against foreign pathogens.
Vaccines introduce or present these foreign pathogens, prompting the body&rsquo;s immune system produce a response protective
against the pathogen without exposing the body to the relevant lethal or harmful infection (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>).
While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to
shortcomings of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to
the current standards of care by harnessing durable and long-lived immune response to specific or multiple antigens.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

</DIV>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global vaccine market has recently experienced
significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As such, market research professionals project the
global vaccine market size to reach $73.78&nbsp;billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This market acceleration has been coupled with various
strategic transactions in the sector, including consolidations and mergers and acquisitions in recent&nbsp;years. Major market participants
have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings. For instance,
in February&nbsp;2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines across the
globe. Additionally, in October&nbsp;2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired PaxVax
for $270&nbsp;million, and in July&nbsp;2017 Sanofi acquired Protein Sciences for $650&nbsp;million. The appetite of these companies to
buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
and worldwide.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;Centers for Disease Control, or CDC,
its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations for
both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
adoption.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine candidates are being developed in a
manner that is scalable, designed to be cost-effective and provide long-term benefit to patients from infectious agents.</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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_001.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"></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-indent: 0.25in">The FDA regulatory approval process is lengthy and time-consuming,
and we may experience significant delays in the clinical development and regulatory approval of our vaccine candidates. Our vaccine candidates
are in early stages of development and may fail in development or suffer delays that materially and adversely affect their commercial
viability. We may be unable to complete development of or commercialize our vaccine candidates or experience significant delays in doing
so due to regulatory or other uncertainties.</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"><B>Our Vaccine Platform</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Approach to Stimulating the Immune System for Infectious Disease
Protection</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our S&amp;P platform was co-invented by two researchers,
Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children&rsquo;s Hospital Medical
Center. The pre-clinical research conducted at CHMC provided encouraging data that we believe supports investigation and development of
the platform for our vaccine candidates. The S&amp;P platform combines two or more immunogenic components, a norovirus antigen plus at
least one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity.</P>

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

</DIV>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Key Elements of our Platform</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are leveraging our disruptive norovirus nanoparticle
platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Flexible and Scalable discovery platform engine.&nbsp;&nbsp;&nbsp;&nbsp;</I>We
believe we are able to design and create novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform&rsquo;s
adaptability, we may opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as
well as therapeutics.</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD></TD><TD STYLE="text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Cost-effective and Rapid Production of Novel Vaccines.&nbsp;</I>We
are potentially able to reduce the cost and time to manufacture a vaccine candidate by utilizing an <I>E.coli</I> expression platform,
compared to traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells.
We have bioengineered these nanoparticles to be stable and effective, determined through animal immunogenicity studies, using <I>E.coli
</I>expression, which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system (Pharmaceutics
2019, 11, 472; doi:10.3390/pharmaceutics11090472).</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD></TD><TD STYLE="text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Multi-antigen and Pathogen Capabilities. </I>The power of our platform is its ability to carry
                                                                                     multiple antigens at a time, thereby creating a multi-targeted vaccine. It also provides the opportunity to develop vaccines for
                                                                                     protection against not only viral pathogens, but also bacterial, parasitic and fungal pathogens.</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD></TD><TD STYLE="text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Therapeutic potential. </I>We believe our platform may offer opportunities to develop
                                                                                     non-infectious disease therapeutic products, for example, being used as a carrier or vehicle to transport drugs to specific target
                                                                                     locations.</TD>
</TR></TABLE>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101 and BWV-102: Influenza vaccine program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our lead vaccine program is focused on developing
a transformational novel universal influenza vaccine, BWV-101. This program is licensed from the University of Oxford, where all relevant
studies were performed to support our hypothesis. We are developing a broad-spectrum vaccine using patented epitopes of limited variability,
or ELV, that provide cross reactive immune response to multiple historical flu strains. Additionally, based upon the successful pre-clinical
proof-of-concept (POC) of our H1 epitopes, we are developing a stand-alone H1 influenza vaccine, BWV-102, to provide a long-lasting induced
immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1, H3 and influenza
B.&nbsp;Data in mice models have demonstrated proof of concept of neutralization against historical and current H1 strains, which includes
annual and pandemic strains. This would negate annual flu shots, reformulation and potentially provide protection against future influenza
pandemics. (Thompson et al. Nature Communications. 2018. 9:385).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-201: Streptococcus pneumoniae (S. pneumoniae) vaccine program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">We are developing BWV-201, licensed from St. Jude
Children&rsquo;s Research Hospital, to prevent Acute Otitis Media, or AOM, in children and adults, a leading cause of hospital visits,
prescription antibiotics and potentially permanent hearing loss. AOM due to <I>S. pneumoniae</I> infections range from 30 to 50% of all
AOM infections each year (Monsata 2012 2012; 7(4): e36226). In addition to AOM, we are exploring the potential for BWV-201 to protect
against non-invasive pneumococcal pneumonia, or colonization of the bacteria within the lungs that has not spread to the blood or other
major organs. According to the CDC, pneumococcal pneumonia leads to an estimated 150,000 hospitalizations each year in the US alone (CDC
Fast Facts: Pneumococcal Disease) and while there are commercially available pneumococcal vaccines, efficacy rates against pneumococcal
pneumonia are low (Berild 2020; 9(4): 259) and vaccines are serotype independent (CDC: Pneumococcal Disease). BWV-201 is a live attenuated
serotype-independent intranasal vaccine candidate for <I>S.&nbsp;pneumoniae</I> induced AOM and pneumococcal pneumonia.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-301: Norovirus-rotavirus vaccine program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing a norovirus-rotavirus vaccine,
BWV-301, to prevent gastroenteritis utilizing our S&amp;P platform. Preclinical data from gnotobiotic pig studies have shown our vaccine
can prevent severe gastroenteritis and reduces viral shedding. While rotavirus vaccines exist in the market, no norovirus vaccine is available
to date. Our vaccine would protect people from two of the most globally prevalent viruses causing vomiting and diarrhea.</P>

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

</DIV>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-302: Norovirus-malaria vaccine program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, we are currently investigating a malaria vaccine, BWV-302,
utilizing our norovirus S&amp;P platform. The vaccine is designed to offer protection from both norovirus and malaria, infectious diseases
that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of the plasmodium parasite
being presented on the surface of the norovirus nanoparticle.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-right: 8.7pt; margin-bottom: 0pt"><B>Recent
Developments</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt"><I>&nbsp;</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 15pt 0pt 4.5pt; text-indent: 10.5pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On November 10, 2022, the Company&rsquo;s
Board of Directors approved a share repurchase program to allow for the Company to repurchase up to 5 million shares, with discretion
to management to make purchases subject to market conditions.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 15pt"><I>&nbsp;</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On April 15, 2022, the Company received a demand
letter (the &ldquo;Demand Letter&rdquo;) from Boustead Securities, LLC (&ldquo;Boustead&rdquo;). The Demand Letter alleged that the Company
breached its underwriting agreement with Boustead, in connection with the Company&rsquo;s February 2022 initial public offering. The Demand
Letter alleged that, by engaging H.C. Wainwright &amp; Co., LLC as placement agent for a private placement financing that closed in April
2022 (the &ldquo;April Private Placement&rdquo;), the Company breached Boustead&rsquo;s right of first refusal (&ldquo;ROFR&rdquo;) to
act as placement agent granted to Boustead under the underwriting agreement and, as a result of selling securities in the April Private
Placement, breached the Company&rsquo;s obligation under the underwriting agreement not to offer, sell, issue, agree or contract to sell
or issue or grant or modify the terms of any option for the sale of, any securities prior to February 17, 2023 (the &ldquo;Standstill&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On October 9, 2022, the Company and Boustead entered
into a Settlement Agreement and Release effective as of September 28, 2022, pursuant to which Boustead agreed to waive the ROFR and the
Standstill and to release Company from certain claims with respect to the April Private Placement, the private placement financing closed
in August 2022, and all future private, public equity or debt offerings of the Company. As consideration for such waiver, the Company
agreed to pay Boustead a cash fee of $1,000,000 plus $50,000 in legal expenses and release Boustead from all claims, subject to certain
exceptions. &nbsp;In addition, the Company agreed to issue to Boustead 93,466 shares of restricted common stock in exchange for the cancellation
of that certain Representative Warrant, dated February 23, 2022, issued to Boustead. Concurrent with the execution of the Settlement Agreement,
the Company and Boustead Capital Markets, LLP (&ldquo;Boustead Capital&rdquo;) entered into a three-month Advisory Agreement (the &ldquo;Advisory
Agreement&rdquo;) for which consideration equal to 200,000 shares of restricted common stock, with no vesting provisions, was issuable
to Boustead Capital upon execution of the Advisory Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On August 11, 2022, the Company consummated the
closing of a private placement (the &ldquo;August Private Placement&rdquo;), pursuant to the terms and conditions of a securities purchase
agreement, dated as of August 9, 2022. At the closing of the August Private Placement, the Company issued 1,350,000 shares of common stock,
pre-funded warrants to purchase an aggregate of 2,333,280 shares of common stock and preferred investment options to purchase up to an
aggregate of 4,972,428 shares of common stock. The purchase price of each share of common stock together with the associated preferred
investment option was $2.715, and the purchase price of each pre-funded warrant together with the associated preferred investment option
was $2.714. The aggregate net cash proceeds to the Company from the August Private Placement were approximately $8.7 million, after deducting
placement agent fees and other offering expenses. In addition, the investors in the August Private Placement, who are the same investors
from the April Private Placement, agreed to cancel preferred investment options to purchase up to an aggregate of 1,180,812 shares of
the Company&rsquo;s common stock issued in April 2022. The pre-funded warrants have an exercise price of $0.001 per share, are exercisable
on or after August 11, 2022, and are exercisable until the pre-funded warrants are exercised in full. On September 20, 2022, 945,000 of
the pre-funded warrants were exercised, and as such the Company issued 945,000 shares of common stock on that date. The preferred investment
options are exercisable at any time on or after August 11, 2022 through August 12, 2027, at an exercise price of $2.546 per share, subject
to certain adjustments as defined in the agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Wainwright acted as the exclusive placement agent
for the August Private Placement. The Company agreed to pay Wainwright a placement agent fee and management fee equal to 7.5% and 1.0%,
respectively, of the aggregate gross proceeds from the August Private Placement and reimburse certain out-of-pocket expenses up to an
aggregate of $85,000. In addition, the Company issued warrants to Wainwright (the &ldquo;August Wainwright Warrants&rdquo;) to purchase
up to 220,997 shares of common stock. The August Wainwright Warrants are in substantially the same form as the preferred investment options,
except that the exercise price is $3.3938. The form of the preferred investment options is a warrant, and as such the preferred investment
options, the pre-funded warrants, and the August Wainwright Warrants are collectively referred to as the &ldquo;August Private Placement
Warrants&rdquo;. Further, upon any exercise for cash of any preferred investment options, the Company agreed to issue to Wainwright additional
warrants to purchase the number of shares of common stock equal to 6.0% of the aggregate number of shares of common stock underlying the
preferred investment options that have been exercised, also with an exercise price of $3.3938 (the &ldquo;August Contingent Warrants&rdquo;).
The maximum number of August Contingent Warrants issuable under this provision is 298,346, which includes 70,849 of April Contingent Warrants
that were modified in connection with the August Private Placement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
</DIV>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In connection with the August Private Placement,
the Company entered into a Registration Rights Agreement with the purchasers, dated as of August 9, 2022 (the &ldquo;August Registration
Rights Agreement&rdquo;). The August Registration Rights Agreement provides that the Company shall file a registration statement covering
the resale of all of the registrable securities (as defined in the August Registration Rights Agreement) with the SEC no later than the
30th calendar day following the date of the August Registration Rights Agreement and have the registration statement declared effective
by the SEC as promptly as possible after the filing thereof, but in any event no later than the 45th calendar day following August 9,
2022 or, in the event of a full review by the SEC, the 80th day following August 9, 2022. The registration statement on Form S-1 required
under the Registration Rights Agreement was filed with the SEC on August 29, 2022, and became effective on September 19, 2022.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Upon the occurrence of any Event (as defined
in the August Registration Rights Agreement), which, among others, prohibits the purchasers from reselling the securities for more than
ten consecutive calendar days or more than an aggregate of fifteen calendar days during any 12-month period, and should the registration
statement cease to remain continuously effective, the Company is obligated to pay to each purchaser, on each monthly anniversary of each
such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 2.0% multiplied by the aggregate
subscription amount paid by such purchaser in the August Private Placement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 15.6pt">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On April&nbsp;19, 2022, we consummated the closing
of a Private Placement (the &ldquo;April Private Placement&rdquo;), in which we received approximately $6.9&nbsp;million in net cash proceeds,
pursuant to the terms and conditions of the Securities Purchase Agreement, dated as of April&nbsp;13, 2022 (the &ldquo;April Purchase
Agreement&rdquo;), by and among the Company and certain purchasers named on the signature pages thereto. At the closing of the April Private
Placement, the Company issued 590,406&nbsp;shares of common stock, pre-funded warrants to purchase an aggregate of 590,406&nbsp;shares
of common stock and preferred investment options to purchase up to an aggregate of 1,180,812&nbsp;shares of common stock. The purchase
price of each share and associated preferred investment option was $6.775 and the purchase price of each prefunded warrant and associated
preferred investment option was $6.774. The aggregate gross proceeds to the Company from the April Private Placement were approximately
$8.0&nbsp;million, before deducting placement agent fees and other offering expenses. H.C.&nbsp;Wainwright&nbsp;&amp; Co., LLC (&ldquo;Wainwright&rdquo;)
acted as the exclusive placement agent for the April Private Placement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In connection with the April Private Placement,
we entered into a registration rights agreement with the purchasers, dated as of April&nbsp;13, 2022 (the &ldquo;April Registration Rights
Agreement&rdquo;), pursuant to which we filed a registration statement covering the resale of registrable securities under the April Registration
Rights Agreement, which was declared effective on May&nbsp;20, 2022.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
</DIV>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Upon the occurrence of any Event (as defined in
the April Registration Rights Agreement), which, among others, includes the purchasers being prohibited from reselling the securities
acquired in the April Private Placement for more than ten (10)&nbsp;consecutive calendar&nbsp;days or more than an aggregate of fifteen
(15)&nbsp;calendar&nbsp;days during any 12-month period, we are obligated to pay to each purchaser, on each monthly anniversary of each
such Event, an amount in cash, as partial liquidated damages and not as a penalty, equal to the product of 2.0% multiplied by the aggregate
subscription amount paid by such purchaser pursuant to the April Purchase Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Wainwright served as the exclusive placement agent
for the April Private Placement and received a cash fee of 7.5% of the aggregate gross proceeds of the offering and received warrants
(the &ldquo;April Wainwright Warrants&rdquo;) to purchase up to 70,849&nbsp;shares of our common stock, which was equivalent to 6.0% of
the shares and prefunded warrants sold in the April Private Placement. We also agreed to pay Wainwright a management fee equal to 1.0%
of the aggregate gross proceeds from the offering and reimburse certain out-of-pocket expenses up to an aggregate of $85,000. We also
agreed, upon any exercise for cash of any preferred investment options, to issue to Wainwright warrants to purchase the number of shares
equal to 6.0% of the aggregate number of placement shares underlying the preferred investment options that have been exercised (the &ldquo;April
Contingent Warrants&rdquo;). The maximum number of April Contingent Warrants issuable under this provision is 70,849.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On April&nbsp;20, 2022, the Company and Ology entered
into an amendment to the second Project Addendum (the &ldquo;Ology Amendment&rdquo;). The Ology Amendment provides for an increase to
the Company&rsquo;s obligation of $0.3&nbsp;million, specifically related to regulatory support on the project.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On August 30, 2022, the Company and Ology entered
into another amendment to the second Project Addendum, which provides for a decrease to the Company&rsquo;s obligation of $0.4 million,
as a result of the change in the scope of work comprising certain tasks defined in the second Project Addendum.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 15pt"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>St. Jude Children&rsquo;s Research Hospital, Inc. Agreement</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On May&nbsp;11, 2022, the Company and St. Jude entered
into a first amendment to the St. Jude Agreement (the &ldquo;St. Jude Amendment&rdquo;). The St. Jude Amendment provides for a revised
development milestone timeline, a one-time license fee of $5,000, and an increase to the royalty rate from 4% to 5%. The St. Jude Amendment
also provides for an increase to the contingent milestone payments, from $1.0&nbsp;million to $1.9&nbsp;million in the aggregate; specifically,
development milestones of $0.3&nbsp;million, regulatory milestones of $0.6&nbsp;million, and commercial milestones of $1.0&nbsp;million.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company also entered into a second sponsored
research agreement with St. Jude, dated August 29, 2022, pursuant to which the Company is obligated to pay St. Jude an amount of $75,603
which is due within 30 days of the effective date of the agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Butantan Letter of Intent</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On May&nbsp;19, 2022, the Company and Instituto
Butantan (&ldquo;Butantan&rdquo;) entered into a letter of intent, pursuant to which the Company and Butantan intend to establish a future
technological collaboration in order to improve Butantan&rsquo;s platform and develop the universal influenza vaccine candidate in collaboration
with the Company.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Oxford University Innovation Limited</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In December&nbsp;2018, the Company entered into
an option agreement with Oxford University Innovation (&ldquo;OUI&rdquo;), which was a precursor to a license agreement (the &ldquo;OUI
Agreement&rdquo;), dated July&nbsp;16, 2019. Under the terms of the OUI Agreement, the Company holds an exclusive, worldwide license to
certain specified patent rights and biological materials relating to the use of epitopes of limited variability and virus-like particle
products and practice processes that are covered by the licensed patent rights and biological materials for the purpose of developing
and commercializing a vaccine product candidate for influenza.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to the terms of the OUI Agreement, the
Company entered into a sponsored research agreement (the &ldquo;SRA&rdquo;) dated December&nbsp;18, 2019 with Oxford University relating
to research and optimization of the Company&rsquo;s universal influenza vaccine candidate, BWV-101, which carried a term of three&nbsp;years
and required aggregate payments of &pound;420,000, which was previously paid by the Company. Pursuant to the Sponsor Research Agreement,
Oxford University is required to&nbsp;finalize certain pre-clinical studies of the universal influenza vaccine. On May&nbsp;16, 2022,
the Company entered into an amendment to the Sponsor Research Agreement (the &ldquo;Amendment&rdquo;), the term of the research under
the SRA was extended for an additional 18&nbsp;months, culminating on June&nbsp;18, 2024. The Company will also provide additional funding
in connection with the research in a sum of approximately $56,000.</P>

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

</DIV>

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

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

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

</DIV>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
were incorporated in Delaware on October&nbsp;26, 2018. Our principal executive offices are located at 201&nbsp;E.&nbsp;Fifth Street,
Suite 1900, Cincinnati, Ohio 45202, and our telephone number is (513)&nbsp;620-4101. Our corporate website </FONT>address <FONT STYLE="font-family: Times New Roman, Times, Serif">is
<I>www.bluewatervaccines.com</I>. The information contained on or accessible through our website is not a part of this prospectus, and
the inclusion of our website address in this prospectus is an inactive textual reference only.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center"><B>The Offering</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 29%; text-align: justify"><B>Outstanding Common Stock:</B></TD>
    <TD STYLE="width: 1%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 70%; text-align: justify">15,474,957 shares of our Common Stock are outstanding as of November 9, 2022.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify"><B>Common Stock Offered:</B></TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">Up to 1,000,000 shares of Common Stock for sale by the Selling Stockholders (which include our employees, consultants, executive officers and directors) for their own account pursuant to the 2022 Plan.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify"><B>Selling Stockholders:</B></TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">The Selling Stockholders are set forth in the section entitled &ldquo;Selling Stockholders&rdquo; of
    this reoffer prospectus on page 110. The amount of securities to be offered or resold by means of the reoffer prospectus by the
    designated Selling Stockholders may not exceed, during any three month period, the amount specified in Rule 144I.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify"><B>Use of proceeds:</B></TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">We will not receive any proceeds from the sale of our Common Stock by the Selling Stockholders. We would, however, receive proceeds upon the exercise of the stock options by those who receive options under the Plan and exercise such options for cash. Any cash proceeds will be used by us for general corporate purposes.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify"><B>Risk Factors:</B></TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">The securities offered hereby involve a high degree of risk. See &ldquo;Risk Factors.&rdquo;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify"><B>Nasdaq Capital Market trading symbol:</B></TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">BWV</TD></TR>
  </TABLE>

<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: center"></P>

</DIV>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_003"></A>INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE</B></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: left; text-indent: 0.25in; background-color: white">We
are &ldquo;incorporating by reference&rdquo; in this prospectus certain documents we file with the Commission, which means that we can
disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
are incorporated herein by reference as of their respective dates of filing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 0.25in; text-align: justify">(i)</TD>
    <TD STYLE="text-align: left">our Annual Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;</TD></TR>

<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(ii)</TD><TD STYLE="text-align: left">our Quarterly Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022026516/f10q0322_bluewatervac.htm">Form 10-Q</A> for the quarter ended March
31, 2022 as filed with the SEC on May 13, 2022; our Quarterly Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022048105/f10q0622_bluewater.htm">Form 10-Q</A> for the quarter ended June 30, 2022 as filed with the
SEC on August 15, 2022; and our Quarterly Report on <A HREF="https://www.sec.gov/Archives/edgar/data/1782107/000121390022072376/f10q0922_bluewater.htm">Form 10-Q</A> for the quarter ended September 30, 2022 as filed with the SEC on November
14, 2022&nbsp;;</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: justify; width: 0.25in">(iii)</TD>
    <TD STYLE="text-align: left">our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022010779/ea156505-8ka1_bluewater.htm">Form 8-K/A</A> dated March 4, 2022, our Current Report
on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022014172/ea157195-8k_bluewater.htm">Form 8-K</A> dated March 22, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020636/ea158617-8k_bluewater.htm">Form 8-K</A> dated April 19, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020726/ea158657-8k_bluewater.htm">Form 8-K</A> dated April 20,
2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020785/ea158659-8k_bluewater.htm">Form 8-K</A> dated April 20, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020876/ea158704-8k_bluewater.htm">Form 8-K</A> dated April 21, 2022; our Current Report on
<A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022029402/ea160571-8k_bluewater.htm">Form 8-K</A> dated May 25, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022030666/ea160890-8k_bluewater.htm">Form 8-K</A> dated June 1, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022034900/ea161977-8k_bluewater.htm">Form&nbsp;8-K</A> dated June 24, 2022; our
Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022036064/ea162286-8k_bluewater.htm">Form 8-K</A> dated June 30, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022041300/ea163260-8k_bluewater.htm">Form 8-K</A> dated July 25, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022046943/ea164234-8k_bluewater.htm">Form 8-K</A> dated
August 11, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022050150/ea164773-8k_bluewater.htm">Form 8-K</A> dated August 22, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022055196/ea165633-8k_bluewater.htm">Form 8-K</A> dated September 12, 2022; our Current
Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022063031/ea166966-8k_bluewater.htm">Form 8-K</A> dated October 11, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022063519/ea167009-8k_blue.htm">Form 8-K</A> dated October 12, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022069929/ea168219-8k_bluewater.htm">Form 8-K</A> dated
November 8, 2022; and our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022070854/ea168392-8k_bluewatervac.htm">Form 8-K</A> dated November 10, 2022.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">(iv)</TD>
    <TD STYLE="text-align: left">the description of our securities registered under Section 12 of the Exchange Act as filed as&nbsp;<A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021ex4-2_bluewater.htm">Exhibit 4.2</A>&nbsp;on Annual Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">All documents that we file
with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
indicates that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold,
will be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Any statement contained in
a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
incorporated by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">You may request, orally or in writing, a copy of these documents, which
will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated by reference), by contacting
Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our telephone number is (513)
620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However, the information on our website
is not a part of this prospectus and is not incorporated by reference.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_011"></A>CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
AND INDUSTRY AND MARKET DATA</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Special Note&nbsp;Regarding Forward-Looking Statements</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in">This prospectus contains forward-looking statements
that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled &ldquo;Prospectus
Summary,&rdquo; &ldquo;Risk Factors&rdquo; and &ldquo;The Company,&rdquo; but are also contained elsewhere in this prospectus. In some
cases, you can identify forward-looking statements by the words &ldquo;may,&rdquo; &ldquo;might,&rdquo; &ldquo;will,&rdquo; &ldquo;could,&rdquo;
&ldquo;would,&rdquo; &ldquo;should,&rdquo; &ldquo;expect,&rdquo; &ldquo;intend,&rdquo; &ldquo;plan,&rdquo; &ldquo;objective,&rdquo; &ldquo;anticipate,&rdquo;
&ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;predict,&rdquo; &ldquo;project,&rdquo; &ldquo;potential,&rdquo; &ldquo;continue&rdquo;
and &ldquo;ongoing,&rdquo; or the negative of these terms, or other comparable terminology intended to identify statements about the future,
although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance
or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity,
performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking
statements include, but are not limited to, statements about:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our projected financial position and estimated cash burn
rate;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our estimates regarding expenses, future revenues and capital
requirements;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our ability to continue as a going concern;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our need to raise substantial additional capital to fund
our operation;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the success, cost and timing of our clinical trials;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our dependence on third parties in the conduct of our clinical
trials;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our ability to obtain the necessary regulatory approvals
to market and commercialize our product candidates;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the ultimate impact of the ongoing COVID-19 pandemic, or
any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a
whole;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the potential that results of pre-clinical and clinical trials
indicate our current product candidates or any future product candidates we may seek to develop are unsafe or ineffective;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the results of market research conducted by us or others;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to obtain and maintain intellectual property
protection for our current product candidates;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to protect our intellectual property rights and
the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the possibility that a third party may claim we or our third-party
licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial
costs and be required to devote substantial time defending against claims against us;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our reliance on third parties;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the success of competing therapies and products that are
or become available;</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to expand our organization to accommodate potential
growth and our ability to retain and attract key personnel;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the potential for us to incur substantial costs resulting
from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization
of our product candidates;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">market acceptance of our product candidates, the size and
growth of the potential markets for our current product candidates and any future product candidates we may seek to develop, and our
ability to serve those markets; and</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the successful development of our commercialization capabilities,
including sales and marketing capabilities.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These forward-looking statements are subject to
a number of risks, uncertainties and assumptions, including those described in &ldquo;Risk Factors.&rdquo; Moreover, we operate in a very
competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all
risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties
and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ
materially and adversely from those anticipated or implied in the forward-looking statements.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You should not rely upon forward-looking statements
as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking
statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for
the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements
for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You should read this prospectus and the documents
that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus forms
a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially
different from what we expect.&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_004"></A>THE COMPANY</B></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"><B>Overview</B></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-indent: 0.25in">We are a biotechnology company focused on the
research and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique
molecular properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines.
Our lead influenza (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties
that enables the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and
long-term immunity. We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines
to improve both health outcomes and quality of life globally.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">Our pipeline includes novel vaccine candidates exclusively
licensed from renowned research institutions. We seek to develop vaccines that provide long-lasting immunity to harmful viral and bacterial
pathogens that cause infections in patient populations with high unmet needs. Our exclusive license agreements include patented influenza
epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered by
Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. Our collaborators are pioneers in vaccine discovery and development.
We are exploring the development of these influenza ELV&rsquo;s utilizing our Norovirus shell and protrusion (S&amp;P) nanoparticle vaccine
platform licensed from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC.&nbsp;We are also utilizing our platform to develop
a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus. We are also utilizing this platform to assess the
potential to create a novel monkeypox vaccine candidate. Our exclusively licensed S. pneumoniae vaccine candidate is from St. Jude Children&rsquo;s
Research Hospital. The vaccine is designed to prevent harmful middle-ear infections in children and is being developed for intranasal
delivery well suited for pediatric patients. We are also exploring the potential for this vaccine candidate to protect individuals, particularly
elderly individuals, against pneumococcal pneumonia. We leverage the expertise of our collaborators to pursue the discovery and development
of vaccines for these diseases, which are high unmet needs globally.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we have expertise in identifying
business development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion
and the ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There
is potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccination has been used as an effective method
of protecting individuals against harmful diseases by utilizing the body&rsquo;s natural defense system to develop resistance or immunity
to infections (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>). The body&rsquo;s
immune system naturally creates antibodies and cell &mdash; mediated immunity to defend against foreign pathogens. Vaccines
introduce or present these foreign pathogens, prompting the body&rsquo;s immune system produce a response protective against the pathogen
without exposing the body to the relevant lethal or harmful infection (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>).
While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to shortcomings
of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to the current standards
of care by harnessing durable and long-lived immune response to specific or multiple antigens.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global vaccine market has recently experienced
significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As such, market research professionals project
the global vaccine market size to reach $73.78&nbsp;billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This market acceleration has been coupled with
various strategic transactions in the sector, including consolidations and mergers and acquisitions in recent&nbsp;years. Major market
participants have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings.
For instance, in February&nbsp;2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines
across the globe. Additionally, in October&nbsp;2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired
PaxVax for $270&nbsp;million, and in July&nbsp;2017 Sanofi acquired Protein Sciences for $650&nbsp;million. The appetite of these companies
to buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
and worldwide.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;Centers for Disease Control, or
CDC, its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations
for both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
adoption.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine candidates are being developed in
a manner that is scalable, designed to be cost-effective and provide long term benefit to patients from infectious agents.</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: center"><IMG SRC="image_022.jpg" ALT="">&nbsp;</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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA regulatory approval process is lengthy and
time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our vaccine candidates.
Our vaccine candidates are in early <FONT STYLE="font-family: Times New Roman, Times, Serif">stages</FONT> of development and may fail
in development or suffer delays that materially and adversely affect their commercial viability. We may be unable to complete development
of or commercialize our vaccine candidates or experience significant delays in doing so due to regulatory or other uncertainties.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We aim to identify, discover and develop novel
preventive vaccines for infectious diseases. Key elements of our strategy include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Investment in advancing the development of our novel vaccine
pipeline programs through IND-enabling activities and Phase&nbsp;I clinical studies.</B></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We plan to advance
                                            our main vaccine programs: influenza, S. <I>pneumoniae</I> induced AOM and pneumococcal pneumonia,
                                            norovirus-rotavirus, and norovirus-malaria.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our in-licensed vaccine candidates are carefully selected
based on the following criteria: area of significant unmet medical need for preventive long-term vaccine; strong scientific rationale
and established clinical and regulatory pathways; defined competitive landscape and potential future commercial opportunity; and license
exclusivity.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Prioritizing the research and development for our lead
influenza vaccine candidates, BWV-101 and BWV-102 through Phase&nbsp;I.</B></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our goal is to develop a universal influenza vaccine that
protects against all strains of influenza, including pandemic strains. In collaboration with The University of Oxford and CHMC, we are
evaluating vaccine candidates to pursue the best development path forward to stimulate durable and broad-spectrum immunogenicity.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We will leverage the pre-clinical and clinical experience
we gain from the development of BWV-102 to accelerate the development of the BWV-101 program. We expect that the manufacturing and clinical
data collected will provide invaluable insight for development of the universal vaccine candidate.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Maximize and utilize the value of our collaborators and
third-party vendors.</B></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We will combine disciplined business strategies to further
expand the potential synergies with current collaborators.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Deploy and expand our proprietary norovirus S&amp;P nanoparticle
platform.</B></TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our immunogenic multi-purpose vaccine platform technologies
can be utilized with an array of infectious disease agents to access multiple development pathways and allow for potential next-generation
life cycle management to expand our pipeline and pursue business development opportunities. There is potential for the platform to pursue
adjunctive therapies to currently available drugs, and for current therapies to be re-optimized and formulated to protect against multiple
antigens.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Blue Water Vaccines Inc. was founded in October&nbsp;2018
by our Chief Executive Officer, or CEO, Joseph Hernandez, with the initial goal of developing a transformational universal flu vaccine
to treat and prevent infections in patients globally. Our initial technology, licensed from the University of Oxford, provides a novel
approach to developing a universal influenza vaccine. Subsequently, our team has identified other program candidates and technologies
to broaden and diversify our vaccine pipeline.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">Mr. Hernandez, our Chairman and CEO, is a veteran
entrepreneur, philanthropist, and operator with a broad skillset of founding, building, and selling companies, as well as executing business
development transactions and securing private and public capital, including Digene, Noachis Terra and Blue Water Acquisition Corp. Mr.
Hernandez was responsible for our initial $7 million seed funding round from investors including CincyTech. In addition to his position
as our Chairman and CEO, Mr. Hernandez also served on the board of directors for Clarus Therapeutics, Inc. (Nasdaq: CRXT) until August
2022, and serves on the board of certain other private companies. Subsequently, a team of veteran industry executives and advisors were
assembled, bringing valuable expertise to our growing infectious disease company.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">Jon Garfield, our Chief Financial Officer, has over
20&nbsp;years of financial leadership experience, including with healthcare companies. Mr.&nbsp;Garfield regularly provides consulting
services to private equity funds and privately held companies and has served as the CEO of Unity MSK since February&nbsp;2021, and served
as interim Chief Financial Officer of Blue Water Vaccines Inc. from September&nbsp;2021 until the consummation of our initial public offering
in February&nbsp;2022, upon which he became our full-time Chief Financial Officer. Erin Henderson, who serves as our Chief Business Officer
and Corporate Secretary, has over 20&nbsp;years of leading strategic transactions, governmental and stakeholder relations and corporate
expansion. Previously, since 2010 she was the Managing Principal at The Aetos Group, a management consulting firm serving both the public
and private sectors. Andrew Skibo is our Head of Biologic Operations and was recently Head of Global Biologics Operations at MedImmune/AstraZeneca
and previously worked for Amgen and Genentech (now Roche), where he was responsible for operations, engineering, construction, and validation
for large-scale capital projects related to bio-pharmaceutical manufacturing. Ronald Cobb, Ph.D., our Head of Science and Discovery, was
recently Chief Scientific Officer at Ology Bioservices (formerly Nanotherapeutics) and previously worked for RTI Biologics and Berlex
Biosciences. Brian Price, Ph.D., our Head of Technology Strategy, brings over 20&nbsp;years of successful product development experience
and business development growth based on programs in toxicology, analytics, and therapeutic and vaccine development.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Additionally, members of our Board of Directors have extensive expertise
in the fields of life sciences, business, and finance. In addition to Mr. Hernandez, our directors include Kimberly Murphy, former VP,
Commercialization Leader, influenza at GlaxoSmithKline, President, CEO and Director of Oragenics, Inc. (Nasdaq: OGEN) and former Chair
of Clarus Therapeutics (Nasdaq: CRXT), Simon Tarsh, a retired Deloitte Consulting Managing Director with experience in Life Sciences,
James Sapirstein, R.Ph., M.B.A, President, CEO and Chairman of First Wave BioPharma, Inc. (Nasdaq:FWBI), and Vuk Jeremi&amp;cacute;, previous
Chair of the Council of Europe&rsquo;s Committee of Ministers and previous President of the United Nations General Assembly. Our Scientific
Advisory Board includes Sunetra Gupta, Ph.D., Professor of Theoretical Epidemiology at The University of Oxford, a leading voice in infectious
disease globally; and John Rice, Ph.D., Managing Director at CincyTech, with more than 30&nbsp;years of biotechnology advising experience.</FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">Subject to certain non-compete restrictions, our
chief executive officer, Joseph Hernandez, and other key personnel may pursue other business or investment ventures while employed with
us. Accordingly, they may have conflicts of interest in allocating time among various business activities and potentially competitive
fiduciary and pecuniary interests that conflict with our interests. See &ldquo;Risk Factors&nbsp;&mdash;&nbsp;Our Chief Executive Officer,
Joseph Hernandez and our Chief Financial Officer, Jon Garfield, hold certain management positions and directorships of other companies
and may allocate their time to such other businesses, which may cause conflicts of interest in their determination as to how much time
to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.&rdquo; Any such
additional business activities or ventures may present conflicts to our interests. We do not believe that any such potential conflicts
would materially affect our ability to conduct our operations.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt"><I>Bioengineering the shell (S)&nbsp;and protruding
(P)&nbsp;domains of the norovirus capsid protein, polyvalent nanoparticles and polymers/oligomers provide a versatile vaccine platform
with wide applications</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt"><I>Our Approach to Stimulating the Immune System
for Infectious Disease Protection</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our S&amp;P platform was co-invented by two researchers,
Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children&rsquo;s Hospital Medical
Center. The pre-clinical research conducted at CHMC provided encouraging data that supports further investigation and development of the
platform for our vaccine candidates. The S&amp;P platform combines two or more immunogenic components, a norovirus antigen plus at least
one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity of the inserted antigen.
The S&nbsp;&amp; P particles themselves also act as antigens, and are large enough to trigger an immune response to a foreign substance.
By combining the norovirus nanoparticle with one or more antigens from other infectious disease(s), the immune system is stimulated to
create antibodies to both the norovirus and the additional antigen(s).</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Key Elements of our Platform</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are leveraging our disruptive norovirus nanoparticle
platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left"><I>Flexible and Scalable discovery platform engine. </I>We believe we are able to design and create
                                                                                       novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform&rsquo;s adaptability, we may
                                                                                       opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as well as
                                                                                       therapeutics.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left"><I>Cost-effective and Rapid Production of Novel Vaccines.&nbsp;&nbsp;&nbsp;&nbsp;</I>We are potentially
                                                                                       able to reduce the cost and time to manufacture a vaccine candidate by utilizing an <I>E.coli</I> expression platform, compared to
                                                                                       traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells. We
                                                                                       have bioengineered these nanoparticles to be stable and effective, as determined through animal immunogenicity studies, using <I>E.coli </I>expression
                                                                                       which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system (Pharmaceutics 2019, 11,
                                                                                       472; doi:10.3390/pharmaceutics11090472).</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-align: left; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Multi-antigen and Pathogen Capabilities. </I>One
of the key features of our platform is its ability to carry multiple antigens at a time, thereby creating a multi-targeted vaccine. It
also provides the opportunity to develop vaccines for protection against not only viral pathogens, but also bacterial and potentially
parasitic and fungal pathogens.</TD>
</TR></TABLE>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-align: left; text-indent: -24pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Therapeutic potential</I>. We believe our platform may offer opportunities to develop
                                                                                       non-infectious disease therapeutic products, for example being used as a carrier or vehicle to transport drugs to specific target
                                                                                       locations.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-align: left; text-indent: -24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Viral capsid proteins are responsible for many
basic functions necessary for viral life cycles, such as viral attachment and entry, and thus can elicit neutralizing antibodies against
viral infection after immunization to humans and animals. Consequently, viral capsid proteins are promising vaccine targets against viral
infection. Indeed, various capsid protein nanoparticles and complexes have been developed and used as nonreplicating subunit vaccines
to combat various infectious diseases.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Unlike traditional live-attenuated and inactivated
virus vaccines that need cultivation of infectious virions and are associated with certain safety concerns, the nonreplicating VLP vaccines
derived from bioengineered viral capsid proteins do not involve an infectious agent and, therefore, may be safer and have lower manufacturing
costs than traditional vaccines. Thus, VLP vaccines represent a next generation of innovative vaccine strategy.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The NoV (VP1) capsid structure consists of two major domains:
(i) a N-terminal shell (S)&nbsp;domain and (ii) a C-terminal protruding (P)&nbsp;domain. The S domain builds the interior shell of the
capsid and the P domain forms the dimeric protrusions of the capsid.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The protrusions (P)&nbsp;of norovirus capsid interact with
viral glycan receptors for attachment to host cells to initiate an infection.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The S domain interacts homotypically and drives self-formation
of an approximately 60 nm VLP.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The P domain exhibits homotypic interactions, forming a 24
nm VLP with dimeric protrusions for stabilization of the viral capsid. Additionally, it can also form oligomers or polymers.</TD>
</TR></TABLE>
<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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_003.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 1. </B>Lineage structures of norovirus
capsid protein or viral protein 1 (VP1) and various nanoparticles derived from full-length or truncated VP1. The N-terminal shell (S)&nbsp;(green)
and the C-terminal protruding (P)&nbsp;(dark blue) domains with a short flexible hinge (light blue) in between (with amino acid numbers
based on GI.1 Norwalk virus VP1) are shown. (A)&nbsp;Production of full-length norovirus VP1s via a eukaryotic expression system self-assembles
into virus-like particles (VLPs). (B)&nbsp;Production of the S or P domain via the <I>Escherichia coli</I> expression system self-assembles
into S or P nanoparticles.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Due to the homotypic interaction attributed to
the norovirus capsid domains, researchers at CHMC, through bioengineering, designed and generated two subviral nanoparticles, the 24-valent
P<SUB>24 </SUB>and the 60-valent S<SUB>60</SUB> nanoparticles, and P-derived polymers to serve as a multifunctional vaccine platform against
different pathogens and illnesses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">These nanoparticles and polymers are easily produced, highly
stable, and extremely immunogenic which we believe makes them compelling platforms to serve to display foreign antigens, self-assembling
into chimeric nanoparticles or polymers as vaccine candidates.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">There are several preclinical studies that showed P<SUB>24</SUB>/S<SUB>60
</SUB>chimeric vaccine candidates that can display different foreign antigens and epitopes, as set forth below in Tables 1 and 2. Therefore,
there may be additional candidates to further explore as human vaccines. <I>(Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I>.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Such VLPs and capsid-like nanoparticles may be excellent
vaccine candidates against corresponding viral pathogens because they can retain arrays of antigenic epitopes that faithfully mimic those
of the native virions, and these repeated viral antigens and epitopes stimulate strong immune responses in their animal and human hosts.
In addition, such highly immunogenic subviral nanoparticles may also serve as versatile platforms that are able to display foreign antigens
for improved immune responses to facilitate development of novel vaccines against various pathogens and diseases.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The fact that the P<SUB>24</SUB> VLP nanoparticles and polymers
are composed of authentic norovirus antigens and retain norovirus-specific molecular patterns make it an excellent vaccine candidate
against the norovirus.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">In addition, the natures of self-formation, high stability,
polyvalence, and high immunogenicity, as evidenced by animal studies conducted in gnotobiotic pig models and mouse models, results included
herein, of the nanoparticles and polymers make them strong vaccine candidate platforms to display foreign antigens, resulting in chimeric
nanoparticles as vaccine candidates against further pathogens and diseases.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our multifunctional vaccine platform is a robust
discovery engine and has broad application using both S<SUB>60</SUB> and P<SUB>24</SUB> nanoparticles to target multiple pathogens and
illnesses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The P<SUB>24</SUB> nanoparticle has also been
used to display multiple viral epitopes for enhanced immunogenicity for novel subunit vaccine development, see Table 1 below. These include
the M2e epitope of the matrix 2 (M2) protein and the HA2 protein B cell epitope of influenza viruses, the B cell epitope of VP3 of enterovirus
71 (EV71), the 4E10 and 10E8 epitopes of human immunodeficiency virus type 1 (HIV-1), among others.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 1. Summary of norovirus nanoparticles and polymers as vaccine
candidates and platforms to display foreign antigens and epitopes.</B></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 16%; border-bottom: black 1.5pt solid; text-align: center"><B>Nanoparticle/ Polymer</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 26%; border-bottom: black 1.5pt solid; text-align: center"><B>Antigen/Epitope to be Displayed (Pathogen)</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 26%; border-bottom: black 1.5pt solid; text-align: center"><B>Chimeric Products as <BR>
Vaccine Candidate</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 29%; border-bottom: black 1.5pt solid; text-align: center"><B>Immunity against <BR>
Pathogens or Diseases</B></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">S<SUB>60</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">VP8* (rotavirus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">S<SUB>60</SUB>&nbsp;&ndash;&nbsp;VP8*</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Rotavirus</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P domain (norovirus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Norovirus</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">VP8* (rotavirus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P<SUB>24</SUB>&nbsp;&ndash;&nbsp;VP8*</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Rotavirus and norovirus</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">M2e (influenza virus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P<SUB>24</SUB>&nbsp;&ndash;&nbsp;M2e</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Influenza virus</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">HA2 B cell epitope <BR>
(influenza virus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Trivalent HA2-PP (P<SUB>24</SUB>-HA2:90-105)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Influenza A virus and influenza B virus</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">VP3 B cell epitope (EV71)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">PP-71-6 (P<SUB>24</SUB>-71-6)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">EV71</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">4E10/10E8 epitopes (HIV-1)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">4E10-PP/10E8-PP</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">HIV-1</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Amyloid-beta, A&beta;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">PP-3copy-A&beta;1-6</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Alzheimer&rsquo;s disease</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">P polymer</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P domains (noroviruses)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">NoV P<SUB>GI</SUB>-NoV P<SUB>GII</SUB> <BR>
GST NoV P<SUP>+</SUP></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Different noroviruses</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P polymer</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P domain (HEV)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">NoV P-HEV P</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Norovirus and HEV</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">P polymer</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P domain (astrovirus) P domain (HEV)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Ast P-HEV P-NoV P</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Norovirus, astrovirus, <BR>
and HEV</TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">P polymer</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">P domain (astrovirus) P domain (HEV) <BR>
VP8* (rotavirus)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Ast P-HEV P-VP8*</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">Rotavirus, astrovirus, <BR>
and HEV</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Note: EV71, enterovirus 71; HIV-1, human immunodeficiency virus type
1; HEV, hepatitis E virus; Ast, astrovirus, NoV, norovirus, P, protruding domain; P+, the P domain with an end-linked cysteine-containing
peptide that can self-assemble into oligomers; PP, P particle; GI, norovirus genogroup&nbsp;I; GII, norovirus genogroup&nbsp;II.&nbsp;Please
see the main text for details.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>The S<SUB>60</SUB> Nanoparticle as a Multifunctional vaccine platform</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Recent technology has generated S nanoparticles
using an <I>E. coli</I> system with stabilized expression and self-assembly. The S nanoparticles feature exposed C-terminal flexible hinge
sites that offer ideal fusion sites for displaying foreign antigens.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Researchers at CHMC have developed a technology
to produce uniform 60-valent NoV S<SUB>60 </SUB>nanoparticles with high efficiency using a simple bacterial expression system. This was
achieved by taking advantage of the homotypic interactions of the NoVVP1 S domain that naturally builds the interior shells of NoV capsids,
as well as several modifications to stabilize the S domain proteins and enhance the inter-S domain interactions, respectively. Specifically,
we introduced an R69A mutation to destruct the exposed protease cleavage sites on the surface of the native shell that otherwise leads
to easy degradation of the S proteins. In addition, we introduced triple (V57C/Q58C/S136&rsquo;C) cysteine mutations to establish inter-S
domain disulfide bonds between two pairs of sterically close residues that belong to two neighboring S domains. This led to significantly
enhanced stability and yields of the self-assembled S<SUB>60</SUB> nanoparticles produced by the simple <I>E. coli</I> system. The below
bullets are supported by published data by Ming Tan, the co-inventor of the S&amp;P platform, and his research team at CHMC.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">An important feature of our technology was to rationally
introduce intermolecular disulfide bonds to stabilize the S<SUB>60</SUB> nanoparticles. This approach could also be used to stabilize
other viral protein particles or complexes.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The 60 freely exposed C-termini are a key feature facilitating
the S<SUB>60</SUB> nanoparticle to be a useful vaccine platform. Foreign antigens or epitopes can simply be fused to the end of the S
domain via flexible linker through recombinant DNA technology.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Uniform 60-valent NoV VLPs or S particles produced in a bacterial
expression system have not been produced before.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Importantly, our S<SUB>60</SUB> nanoparticles maintained
the native conformation with authentic antigenicity; thus, our NoV S<SUB>60</SUB> nanoparticle technology represents a significant bioengineering
advancement as uniform 60-valent NoV VLP or S particle <I>via</I> an expression system have never been produced before (Xia et al. ACS
Nano 2018, 12, 10665&minus;10682).</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Uniform complexity and size of vaccine particles are important
factors in quality control of vaccine products, as variations in complexity and size will result in variations in immunization outcomes
of the vaccines.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Broad application to fuse several antigens to the S<SUB>60</SUB>
nanoparticle based on multiple studies shown below conducted by CHMC (Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC has been able to fuse several antigens to
the S<SUB>60</SUB> nanoparticle to the same exposed S domain C-terminus via the same linker. These included (1)&nbsp;the rotavirus (RV)
surface spike protein VP8*; (2)&nbsp;the HA1 antigen or receptor-binding domain (RBD) (223&nbsp;amino acids) of the hemagglutinin (HA)
of anH7N9 influenza A virus; (2)&nbsp;the TSR antigen (67&nbsp;amino acids) of the circumsporozoite surface protein (CSP) of the malaria
parasite Plasmodium falciparum; (3)&nbsp;the protruding domain antigen (187&nbsp;amino acids) of a hepatitis E virus; (4)&nbsp;a longer
version of the RV VP8*antigen (231&nbsp;amino acids); and (5)&nbsp;the VP8*antigen (159&nbsp;amino acids) of the murine RV (mRV) EDIM
strain (Table 1). Particle formations of these fusion proteins have been shown by gel-filtration and/or EM (Table1). In addition, they
have shown that the S<SUB>60</SUB>nanoparticle-displayed HA1 and mRV VP8*antigens elicited significantly higher HA1- and mRV VP8*-specific
antibody titers, respectively, than those elicited by the free HA1 or mRV VP8*antigens (Table 2).</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 2. List of Antigens That Have Been Displayed by the S<SUB>60</SUB>
Nanoparticles</B></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid"><B>epitope/antigen</B></TD>
    <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>size <BR>
(residue)</B></TD>
    <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>yield (mg/L <BR>
bacteria culture)</B></TD>
    <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>S<SUB>60</SUB>&nbsp;&ndash;&nbsp;antigen <BR>
particle<BR>
 formation</B></TD>
    <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>significant<BR>
 immune<BR>
 enhancement<BR>
 in mice<I><SUP>f</SUP></I></B></TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="width: 62%">RV VP8* antigen</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 8%; text-align: center">159</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; text-align: center">~40</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; text-align: center">yes</TD>
    <TD STYLE="width: 1%">&nbsp;</TD>
    <TD STYLE="width: 8%; text-align: center">yes</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD>HA1 antigen<I><SUP>a</SUP></I></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">223</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">~10</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD>TSR/CSP antigen<I><SUP>b</SUP></I></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">67</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">~10</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">ND</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD>full RV VP8* antigen<I><SUP>c</SUP></I></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">231</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">~20</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">ND</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD>murine RV VP8* antigen<I><SUP>d</SUP></I></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">159</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">~5</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD>HEV protruding domain antigen<I><SUP>e</SUP></I></TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: center">187</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">~10</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">yes</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center">ND</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>a</I></TD>
    <TD>HA1 antigen containing the receptor binding site is the head portion of the hemagglutinin (HA) of H7N9 influenza A virus.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>b</I></TD>
    <TD>TSR/CSP antigen is the C-terminal portion of the major surface protein of acircumsporozoite (CSP) that plays a key role in host cell invasion of the malaria parasite Plasmodium falciparum.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>c</I></TD>
    <TD STYLE="text-align: justify">Full RV VP8*antigen is the full-length VP8*domain of the spike protein of a human P[8] rotavirus.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>d</I></TD>
    <TD>Murine RV VP8*antigen is the core portion of the VP8*protein constituting the head of the spike protein of a murine rotavirus EDIM strain.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>e</I></TD>
    <TD STYLE="text-align: justify">HEV protruding domain antigen is part of the protruding domain of a hepatitis E virus capsid.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px"><I>f</I></TD>
    <TD>Immune enhancements of the S<SUB>60</SUB> nanoparticle-displayed antigens were measured in mice using free monomeric antigens as control for comparisons. &ldquo;ND&rdquo; = not determined.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>S<SUB>60</SUB> nanoparticles may serve as a polyvalent vaccine platform
(Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We believe the self-assembled, polyvalent S<SUB>60</SUB>
nanoparticle with 60 flexibly exposed S domain C-termini is an ideal vaccine platform for antigen presentation and immunogenicity enhancement.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">This has been supported by studies showing that when Hisx6
tag was fused to the hinge of the S domain via a linker, fusion proteins self-formed into the S<SUB>60</SUB> nanoparticles.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">This has also been demonstrated by constructing a chimeric,
and reconfirmed by cyroEM density map, S<SUB>60</SUB> nanoparticle displaying 60 RV (rotavirus) VP8* proteins, the major rotavirus neutralizing
antigen. The S<SUB>60&nbsp;</SUB>-VP8*particles can be easily produced with high stability. The chimeric nanoparticle induced higher
immunoglobulin, or IgG, response in mice (n=6) toward the displayed VP8*antigen than soluble VP8* antigen. Mouse sera experiments were
completed analyzing vaccinated versus the control group to show neutralizing activity against RV infection. The statistical differences
between the groups are (*P &lt; 0.05, **P &lt; 0.01, ***P &lt; 0.001) as shown below (Figure 2) (Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The RV surface spike protein, VP8* was tested for feasibility
of the S<SUB>60</SUB> nanoparticle by the analysis using EM micrograph examination and ESI-MS analysis. S<SUB>60</SUB>-VP8*particles
exhibited stronger blockade in mice (n=6) sera after vaccination (P=0.0003) (Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The polyvalent B- and T-cell epitopes of the antigens on
the polyvalent VLP platform led to induction of stronger humoral and cellular immune responses, respectively, in animals and humans compared
with those elicited by the monovalent epitopes of the free antigen. Thus, the polyvalent VLP platform is likely to increase the immunogenicity
of the displayed antigens. Mouse sera experiments were completed analyzing vaccinated versus the control group to show neutralizing activity
against RV infection. The statistical differences between the groups are (*P &lt; 0.05, **P &lt; 0.01, ***P &lt; 0.001) as shown below.
(Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="image_004.jpg" ALT="">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 2. </B>S<SUB>60</SUB>-VP8*particles
enhanced immunogenicity toward the displayed RV VP8*antigens. The same dose/dosage of the S<SUB>60</SUB>-VP8*particles, free VP8*antigens,
and S<SUB>60</SUB> nanoparticles without VP8*was given to mice (N=6), respectively, followed by measurements of theVP8*-specific IgG responses
(A), 50% blocking titers (BT50) against RV VP8*-glycan ligand interaction (B), and neutralization activity against RV infection/replication
in culture cells (C)&nbsp;of the resulting mouse antisera. (A)&nbsp;VP8*-specific IgG responses/titers elicited by theS60-VP8*particles,
free VP8*antigens, and the S60nanoparticles, respectively. (B)&nbsp;BT50against RV VP8*&minus;ligand interactions by the mouse sera after
vaccination with the same three immunogens, respectively. (C)&nbsp;Neutralizing activity against RV infection/replication in culture cells
by mouse sera after immunization with the same three immunogens, respectively. In all these experiments mouse sera after immunization
with diluent (PBS) are used as negative controls.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>The P<SUB>24</SUB> Nanoparticle as a versatile platform (Tan et
al. Nanomedicine, 2012. 7.6,1-9)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The crystal structure of norovirus VLPs indicates
that P domain is involved in strong dimeric interactions forming dimeric protrusions on the viral surface. The oligomeric interactions
of the P domains are also observed at the five-fold axes to further stabilize the capsid structure. When the P domain protein was expressed
using the <I>E.&nbsp;coli</I> system, it self-assembled into P dimers, as well as 24 valent P nanoparticles, P<SUB>24</SUB>. P dimers
and P<SUB>24</SUB> nanoparticles can exchange dynamically, depending on concentration of the P domain protein, indication that the assembled
P<SUB>24</SUB> particles at this stage were unstable and easy to disassemble back into P dimers. To facilitate P<SUB>24</SUB> nanoparticle
formation, inter-P domain disulfide bonds were introduced through fusion of a cysteine-containing peptide to the end of the P domain.
During the P<SUB>24 </SUB>nanoparticle assembly, the cysteine patches were brought to the center of the P<SUB>24</SUB>&nbsp;nanoparticles,
resulting in sterically close contact and thus forming inter-P domain disulfide bonds that significantly stabilized the P<SUB>24</SUB>
nanoparticles, which could no longer disassemble back into the P dimers.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">P<SUB>24</SUB> nanoparticles can be produced using an <I>E.
coli</I> expression system faster and a lower cost than VLPs.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">Both VLP and P<SUB>24</SUB> nanoparticles without adjuvant
produce innate, humoral, and cellular immunity.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">The platform can be used to display foreign antigens, epitopes
and viral pathogens and non-infectious disease.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Studies have demonstrated immune response against flu, rotavirus,
and norovirus using bi- or trivalent vaccine candidates developed using this approach, noting the potential for the development of a
universal flu vaccine. Pre-clinical studies in influenza and rotavirus are provided below supporting our vaccine candidate programs.
See&nbsp;&mdash;&nbsp;<I>Our Infectious Disease Vaccine Candidates</I>.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Infectious Disease Vaccine Candidates</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Infectious diseases are one of the leading causes
of death worldwide. Infectious disease is caused by microorganisms or pathogens, including viruses, bacteria, fungi, and parasites that
infect an individual and cause disease. Diseases often cause high fever, inflammation, or other symptoms. While some diseases can be treated
with drugs or therapeutics, some infectious agents evolve to become resistant to commonly used drugs, such as antibiotics, and can become
difficult to control. Infectious diseases can be passed from person to person or transmitted by insects or other animals. In many cases,
vaccines are used to elicit a protective immune response in the absence of an infection to render an individual immune to a particular
infectious disease.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101: UNIVERSAL INFLUENZA&nbsp;&amp; BWV-102 H1 INFLUENZA</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The company&rsquo;s lead vaccine programs are
focused on developing transformational and novel influenza vaccines: BWV-101 for an influenza vaccine to provide protection against H1,
H3 and Flu B infections; and BWV-102 for a H1 only vaccine. This program is licensed from the University of Oxford in which all relevant
studies were performed to support our hypothesis. Our goal is to develop a vaccine that protects against all influenza strains that commonly
infect humans by targeting specific parts of the influenza viruses, which are of limited variability across flu strains and induce a strong
protective immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1,
H3 and influenza B.&nbsp;The BWV-101 vaccine candidate may potentially provide a therapeutic benefit that negates the need for annual
vaccination, vaccine reformulation, and provide long-lasting broad protection against the flu to millions globally (Thompson et al. Nature
Communications. 2018. 9:385).</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Influenza is a viral infection of the respiratory
system, causing an infected person to suffer from certain symptoms, including fever, muscle aches, runny nose, cough, congestion, headaches,
and fatigue. The four types of influenza viruses include type A, B, C, and D.&nbsp;The type A and B influenza viruses are referred to
as human influenza viruses that are primarily responsible for seasonal flu epidemics each year. Type A flu viruses are further divided
into two subtypes, named based on differences in two viral surface proteins called hemagglutinin (H)&nbsp;and neuraminidase&nbsp;(N).
Influenza types C and D present a lower priority for vaccination, as Type C viruses cause a mild respiratory illness in humans and has
not been associated with human epidemics, and Type D viruses primarily affect cattle and are not known to cause illness in humans (<I>https://www.cdc.gov/flu/about/viruses/types.htm</I>).</P>

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

<P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="image_005.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 3. </B>This graphic shows influenza
virus types including the two types of influenza viruses (A,B) that cause most human illness and that are responsible for the flu season
each year. Influenza A viruses are further classified into subtypes, while influenza B viruses are further classified into two lineages:
B/Yamagata and B/Victoria.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is a major unmet need for the development
of a novel universal flu vaccine as a prophylactic therapy. Influenza is a major respiratory pathogen. The WHO estimates there are an
estimated 1&nbsp;billion cases of influenza infection with&nbsp;3-5&nbsp;million severe cases and 290,000-650,000 related respiratory
human deaths worldwide every year. The estimate does not take into account deaths from other diseases such as cardiovascular disease,
which can be influenza related. The next influenza pandemic is believed by many experts to be a potentially devastating global health
threat. Influenza mortality rates are highest for the very young and elderly.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global influenza vaccine market was valued
at $3.96&nbsp;billion in 2018, and is projected to reach $6.20&nbsp;billion by 2026, representing a CAGR of 5.9% from 2019 to 2026. Currently,
the standard of care and most effective protection against flu is through annual vaccination. The WHO estimates that worldwide, approximately
$4&nbsp;billion is spent on influenza vaccines annually. However, the flu also a major cause of work absenteeism, leading to an estimated
annual productivity loss in the U.S.&nbsp;of $87&nbsp;billion. Flu vaccination consists of a yearly injection of attenuated or inactivated
(dead) influenza viruses to induce humoral immunity in the form of the antibodies against the current circulating or anticipated seasonal
influenza strains. The induction of antibody-producing B-cells through vaccination allows the immune system to defend the body against
the influenza virus circulating during the winter&nbsp;months.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">An annual seasonal flu vaccine is the best way
to help protect against flu. Vaccination has been shown to have many benefits including reducing the risk of flu illnesses, hospitalizations
and even the risk of flu-related death in children. The CDC recommends use of any licensed, age-appropriate influenza vaccine during the&nbsp;2020-2021
influenza season, including inactivated influenza vaccine (IIV), recombinant influenza vaccine (RIV), or live attenuated influenza vaccine
(LAIV). No preference is expressed for any influenza vaccine over another. Both trivalent and quadrivalent influenza vaccines will be
available. The trivalent vaccines formulation will include A(H1N1) pdm09, A(H3N2) and B/Victoria. The quadrivalent vaccine formulations
will include A(H1N1) pdm09, A(H3N2) and B/Victoria, plus B/Yamagata (<I>https://www.cdc.gov/flu/about/viruses/types.htm</I>).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The current influenza vaccines induce antibodies
that target regions of the virus that are highly variable and have serious shortcomings, as they:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(i)</TD><TD STYLE="text-align: justify">must be administered annually,</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(ii)</TD><TD STYLE="text-align: justify">typically provide protection to only 50% of the individuals
who receive it; and</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(iii)</TD><TD STYLE="text-align: left">need to be updated annually and reformulated 6&nbsp;months
prior to influenza season, such that strains that are subsequently prevalent during the applicable &ldquo;flu season&rdquo; are not protected
against by the vaccine.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Proprietary Epitope Discovery</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Using the technology that we have exclusively
licensed from the University of Oxford, we are developing a universal influenza vaccine. Our exclusive license agreements include patented
influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered
by Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. We have acquired intellectual property for cross-protective epitopes
to be used for our vaccine candidates that were developed and identified through a unique computational discovery process at Oxford University.
The data produced through computational analysis at Oxford has shown that antigen evolution in influenza is limited to certain regions
of the virus that facilitate binding and entry to host cells and these regions of limited antigenic variability are naturally immunogenic
and therefore may be used to develop universal immunity to influenza viruses. We have identified epitopes of limited variability in H1
influenza that have circulated throughout history (since 1918) and make ideal vaccine targets and have completed similar analysis of H3
and Flu B strains for similar epitopes which will be used to produce our lead vaccine candidate BWV-101 as a universal vaccine for influenza
infection. Due to the cross-reactive nature of the H1 epitopes in pre-pandemic H1 influenza A, we are also pursuing the development of
a stand-alone H1 vaccine (BWV-102). These epitopes are able to be formulated into a vaccine candidate using our VLP platform technologies
and may be evaluated using other vaccine technologies through partnerships in order to accelerate development of potential vaccines or
to explore adjunct therapies (Thompson et al. Nature Communications. 2018. 9:385).</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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_006.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Figure 4.</B> Current influenza vaccine targets.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Antigenic Drift (Thompson et al. Nature Communications. 2018. 9:385)</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A single conformational epitope is typically 8
to 15&nbsp;amino acids in length and in an extreme circumstance (where every change creates an escape mutant), a single epitope could
theoretically vary from 208 to 2015 different ways. Therefore, a highly variable virus like influenza should be able to mutate in countless
ways during each subsequent season. This would inevitability lead to an explosion of genetic diversity and numerous circulating strains.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">However, it seems that there is a constraint limiting
how influenza evolves, leading to a single or limited number of strains dominating each season. In 2007, Sunetra Gupta led a group of
researchers at the University of Oxford who published a proprietary mathematical model proposing that the single strain dominance, typically
seen worldwide annually, could be explained by hypothesizing that epitopes of &lsquo;limited variability&rsquo; exist (Antigenic Drift
Hypothesis). The model hypothesizes that while there is a significant amount of mutation of influenza strains, this variability occurs
in a specific portion of the virus, while certain epitopes are required to remain relatively constant and are more limited in their variability
in order for the virus to infect individuals, thus clarifying how influenza is not as variable as commonly thought.</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: center">Antigenic Drift Hypothesis Illustration</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: center"><IMG SRC="image_007.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><B>Figure 5. </B>Identification of a site of limited
variability in the head domain of the H1 Ha.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>b,c</I></TD><TD STYLE="text-align: left">Location of ABS of lowest variability containing position
147 with position 147 shown in yellow and the rest of the site colored in red.</TD>
</TR></TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>d</I></TD><TD STYLE="text-align: left">Phylogenetic trees of pre-pandemic and post-pandemic highlighted
rectangle H1N1with tips colored according to the conformation of the epitope of limited variability (hereafter called OREO). Please note
the re-introduction of H1N1influenza in 1977 involved a strain which previously circulated in 1949/50.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">The Antigenic Drift Hypothesis suggests the existence
of epitopes of limited variability mediate a population&rsquo;s immunity to influenza strains. As a particular influenza strain circulates
in the population, immunity to a specific pattern of epitopes is induced. This leads the virus to change its antigenic configuration and
cycle through its limited repertoire of antigenic conformations. However, population immunity also changes due to birth and death within
the population (i.e. individuals in the population who had experienced and developed immunity to certain conformations die). This allows
prior epitope conformations to reappear. The loss of herd immunity to these epitope of limited variability causes the emergence of epidemics
(<I>Thompson et al. Nature Communications. 2018. 9:385</I>).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Oxford scientists have identified the naturally
antigenic regions that drive immunity to influenza by evaluating serum from these from various age groups of humans using assays and ELISAs
reveal periodic cross-reactivity to ELV.&nbsp;Pseudotype microneutralisation data reveals a cyclical pattern of epitope recognition. The
studies of children&rsquo;s sera were used to detect antibodies and demonstrated that young children ages 6 to 12 had immunity to historical
influenza strains that circulated many&nbsp;years prior to when they were born and they could never have possibly been exposed to, one
of which that last circulated in 1934. Mutagenesis of the identified regions of limited variability in various historical viruses removed
the protective immunity. Furthermore, vaccination of mice, as shown below, with these regions of the influenza virus produced an identical
immune response that was observed in the children. For example, the mice vaccinated with either the region from the influenza virus circulating
in 2006 or 1977 were protected against infection with an influenza with a virus that last circulated in 1934, replicating the immunity
seen in children ages 6 to 12. (Thompson et al. Nature Communications. 2018. 9:385)</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: center"><IMG SRC="image_008.jpg" ALT="">&nbsp;</P>

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<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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_009.jpg" ALT="">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 6. </B>Sequential vaccination using
chimeric HA constructs. Five groups of mice were sequentially vaccinated with 2009-like (blue), 2006-like (red),1995-like (orange), 1977-like
(green) and 1940-like (pink) epitope sequences substituted into H6, H5 and H11 Has. Two further control groups were sequentially vaccinated
with H6, H5 and H11 constructs without any sequence substituted into the Has (vaccinated controls). Further two groups were mock vaccinated
(unvaccinated controls). <I><SUP>c,d,f,g</SUP></I>Pseudotype microneutralisation assays using 0.5&mu;l of sera from the bleed at 21&nbsp;weeks.
Error bars are mean &plusmn; s.e.m.n=6 for experimental groups and control groups. The values provided are an average of two replicates</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This work demonstrated that vaccination with just
four variants of one region of limited variability in H1 influenza was able to elicit immunity to all historical H1 influenza strains.
As these regions periodically reappear and disappear over time, vaccination with all of the possible variants would be expected to provide
protection against future influenza strains as well. The identified epitopes are restricted in their variability due to presence of a
receptor-binding site and small alpha helix structure between disulphide bonds.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The following research findings form the basis
for our influenza vaccine candidates:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">1.</TD><TD STYLE="text-align: justify">Epitopes of limited variability which are under strong immune
selection exist within influenza.</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">2.</TD>
    <TD STYLE="font-size: 10pt; text-align: justify">These epitopes drive the antigenic evolution of influenza.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">3.</TD>
    <TD STYLE="font-size: 10pt; text-align: justify">These epitopes cycle between a limited number of different conformations.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">4.</TD>
    <TD STYLE="font-size: 10pt; text-align: justify">Epitopes of limited variability would make ideal vaccine targets.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101: Universal Influenza Vaccine</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our approach to developing a novel, universal
flu vaccine for the prevention and protection against human influenza strains and potential pandemic strains by targeting specific limited
variability epitopes includes the following steps and processes.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exploring development of an influenza vaccine
utilizing both the S&nbsp;&amp; P nanoparticles to determine the most effective and efficient presentation of our ELVs and the versatile
S&amp;P nanoparticle vaccine platform from CHMC with the H1 influenza antigens. Data in preclinical mice (Rotavirus-specific-antibody-free
BALB/c mice, n=5-7) challenge studies inserted M2e, a spike protein of influenza, into a P-particle loop; showed mice that were vaccinated
had 100% protection when injected with lethal doses of influenza (Tan et al. JOURNAL OF VIROLOGY, Jan. 2011, p. 753&nbsp;&ndash;&nbsp;764).
This dual approach will allow us to gain valuable information as we further the development and manufacturing of the BWV-102 program and
utilize it for the development of BWV-101. We are currently assessing the ELVs to determine the most effective and efficient route of
antigen presentation. Additionally, we are currently optimizing antigens for H3 and Flu B to be included with the identified H1 antigens
to finalize our universal influenza vaccine formulation.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are using established manufacturing methods,
including <I>E.coli</I> fermentation to produce our chimeric proteins, to reduce the cost and increase the efficiency and scalability
of our manufacturing process for the vaccine. The antigens will be displayed by a proprietary virus-like particle (VLP) that can be produced
in <I>E.&nbsp;coli</I> (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472). Our research and discovery model uses bioinformatics
and phylogenetic analysis to identify possible sites of epitopes of limited variability before confirming their existence experimentally.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To date, we have identified naturally immunogenic
epitopes for H1, H3 and influenza B.&nbsp;Bioinformatics studies and wet lab studies suggest that these epitopes, especially H1N1, and
the chimeric scaffold configuration of our vaccine induce immunity due to induction of broad cross-reactive antibodies in other strains
such as H10N3 (bird flu), and pandemic strains including H5NX, H7NX, and H9NX.&nbsp;H9NX (Thompson et al. Nature Communications. 2018.
9:385). Therefore, we foresee the development of H1N1 vaccine as a priority due to its high cross-reactive priorities.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-102 Stand-Alone H1 Vaccine</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing our H1 stand-alone influenza
prophylactic product, BWV-102, to address potential pandemic zoonotic H1 strains, specifically the G4 EA H1N1 identified by scientists
and reported in June&nbsp;2020, as a potential next pandemic strain. BWV-102 is being developed using the H1 ELVs identified by the team
at the University of Oxford. While the product is designed to protect against infection from any H1 strain, there is potential for cross
protection from H5 and H10 strain infections as well. Preclinical studies were conducted in Balb C mice (n=6) using a prime-boost-boost
protocol (Thompson et al. Nature Communications. 2018. 9:385). The proposed Phase&nbsp;I clinical study will employ this prime&nbsp;&mdash;&nbsp;boost
protocol; however, it is possible that a single dose of the vaccine candidate will confer protection against current and historical H1
strains with a prime-boost dose or a single dose.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As reported in 2020, the G4 EA H1N1 strain is
the most prevalent influenza strain circulating among swine populations in China. The strain was first identified in 2016 and has been
monitored by scientists in China through their swine surveillance program. The strain has genes from a mix of pig, avian and human viruses,
including genes from the 2009 H1N1 flu pandemic virus. Currently, the G4 EA H1N1 strain is not transmissible human to human, however,
scientists hypothesize that there is a high likelihood of strain reassortment occurring that could make human to human transmissibility
possible. The current H1N1 influenza strain circulating may provide some protection against disease induced by G4 EA H1N1 infection.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ability of the BWV-102 ELVs to induce an immune
response and protection against heterologous challenge with historical strains was assessed in Balb-C mice (n=6) (<I>Thompson et al. Nature
Communications. 2018. 9:385</I>). We are currently assessing the ELVs in combination with the S<SUB>60</SUB> particle, P<SUB>24</SUB>
particle and a proprietary VLP, currently in development, to determine the most effective and efficient route of antigen presentation.
Manufacturing of the product is expected to occur in <I>E. coli (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472)</I>.
We anticipate results of the VLP presentation assessments in the first half of 2022.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-201 Streptococcus pneumoniae (S. pneumoniae) Vaccine</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">Our BWV-201 vaccine candidate is a live attenuated
serotype-independent vaccine, for which early data supports further investigation to pursue a long-term preventive intranasal vaccine
for <I>S. pneumoniae</I> induced acute otitis media, or AOM, and pneumococcal pneumonia.&nbsp;We in-licensed the novel live attenuated
<I>S. pneumoniae</I> strain from St. Jude Children&rsquo;s Research Hospital, or St. Jude, as a potential serotype independent vaccine.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">The potential of this vaccine to provide a long-term,
leading alternative treatment for AOM and pneumococcal pneumonia and subsequent introduction of a novel preventative standard of care.
The development of a novel vaccine could eradicate potential short-term pain and/or long-term harmful side effects from contracting the
bacteria. Complications from AOM include sensorineural hearing loss, or SNHL, in adults but are more relevant for the endangerment of
children, while pneumococcal pneumonia primarily impacts elderly adults and can lead to hospitalization and subsequent infections.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Researchers from St. Jude developed a strain of
<I>S. pneumoniae</I> that contains greatly reduced virulence yet can transiently colonize the nasopharyngeal cavity, inducing immune responses
to significantly decrease the incidence of AOM and sinusitis as demonstrated in animal models. Our vaccine production is a straightforward
process, utilizing the entire novel attenuated bacterium with purification and concentration steps only in the downstream process, thereby
reducing the time and cost of production significantly compared to commonly used polysaccharide or conjugate vaccines.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Based on information from the American Academy
of Pediatrics, over 5&nbsp;million cases of AOM are reported annually in the U.S., resulting in approximately 30&nbsp;million medical
care visits and over 10&nbsp;million antibiotic prescriptions. AOM is the most common condition treated with antibiotics in the United&nbsp;States
and increasing antibiotic resistance among the organisms responsible for AOM is of concern to researchers.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additional statistics supporting the need for
a novel preventive vaccine:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The global AOM rate is 10.85%, or 709&nbsp;million cases
per year, with 51% occurring in children under 5&nbsp;years old (Tong et al. BMC Health Serv Res. 2018; 18: 318).</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
    <TD STYLE="font-size: 10pt">By 3&nbsp;years of age, 80% of children globally are expected to have at least one episode of AOM. (Vergison&nbsp;A, Lancet Infect Dis. 2010 Mar;10(3):195-203. Doi: 10.1016/S1473-3099(10)70012-8. PMID:&nbsp;20185098.).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
    <TD STYLE="font-size: 10pt">Current treatment for AOM is by antibiotic prescription, with more than 80% of all consultations resulting in a prescription. (Haggard, M.&nbsp;Eur J Pediatr 170, 323&nbsp;&ndash;&nbsp;332 (2011). <I>https://doi.org/10.1007/s00431-010-1286-4</I>).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
    <TD STYLE="font-size: 10pt">Even with the introduction of the pneumococcal conjugate vaccine (PCV13) in 2010,&nbsp;26-36% of cases of AOM in U.S.&nbsp;were caused by <I>S. pneumoniae.</I> (Casey JR, Kaur R, Friedel VC, Pichichero ME.&nbsp;Acute otitis media otopathogens during 2008 to 2010 in Rochester, New&nbsp;York. <I>Pediatr Infect Dis J</I>. 2013;32(8):805-809. Doi:10.1097/INF.0b013e31828d9acc).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
    <TD STYLE="font-size: 10pt">Worldwide cases of AOM due to <I>S. pneumoniae </I>is estimated to be&nbsp;30-50%. (Bergenfelz C, Hakansson AP.&nbsp;Curr Otorhinolaryngol Rep. 2017;5(2):115-124. Doi: 10.1007/s40136-017-0152-6. Epub 2017 May&nbsp;20. PMID: 28616365; PMCID:&nbsp;PMC5446555.).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
    <TD STYLE="font-size: 10pt">An estimated $4.3&nbsp;billion USD is spent on AOM treatment each year in the U.S.&nbsp;alone. (Tong S, BMC Health Serv Res. 2018 May&nbsp;2;18(1):318. Doi: 10.1186/s12913-018-3139-1. PMID: 29720156; PMCID:&nbsp;PMC5932897.).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The current standard of care treatment for AOM
in children is reliant on antibiotics. The resolution rate of AOM in children is 81% without antibiotic treatment vs. 93% with antibiotic
treatment. Antibiotic treatment of AOM in children has limitations, including recurrence within 30&nbsp;days.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pneumococcal pneumonia, caused by colonization of
<I>S. pneumoniae</I> in the lungs, primarily impacts elderly adults and according to the CDC, results in approximately 150,000 hospitalizations
in the United States alone each year. In addition to the disease burden, pneumococcal pneumonia accounts for approximately $1.3 billion
in direct medical costs annually plus costs associated with lost productivity (O&rsquo;Brien K, Pneumococcus, Pneumococcal Disease and
Prevention, The Vaccine Book (Second Edition), Academic Press, 2016, Pages 225-243, ISBN 9780128021743). While there are currently available
pneumococcal vaccines, outlined below, these vaccines provide limited levels of protection against pneumonia, as they are administered
intramuscularly and do not elicit strong mucosal immunity (Berild JD, 2020. Pathogens, 9(4), 259. DOI: 10.3390/pathogens9040259). This
technology from St. Jude is delivered intranasally, which is hypothesized to provide adequate levels of mucosal immunity to prevent non-invasive
pneumococcal disease, including pneumonia and AOM.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CDC recommends broad pneumococcal vaccines
for children younger than 2 and for adults over 65&nbsp;years of age (CDC). The CDC also recommends vaccinations for children and adults
age 2 through 64 either previously unvaccinated or partially vaccinated. Two vaccines are currently approved in the U.S.&nbsp;and other
countries: Prevnar13 or PCV13 (Pfizer) (ii)&nbsp;Pneumovax or PPSV23 (Merck). An additional vaccine, Synflorix, is for approved use outside
of the U.S.&nbsp;for the prevention of pneumococcal disease and <I>S. pneumoniae</I> induced AOM for the 10 serotypes included in the
vaccine.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Therefore, an effective serotype independent <I>S.
pneumoniae</I> AOM vaccine could significantly impact pediatric healthcare demand and may reduce hospitalizations for pneumococcal pneumonia
in older adults. As a preventative treatment, the vaccine&rsquo;s advantages include: reduction of near-term pain; reduction of recurrent
AOM that may result in the need for tympanostomy tube placement; lessening of antibiotic usage, which would decrease the number of antibiotic
resistant organisms in the environment; avoiding potential long-term hearing loss; and prevention of hospitalizations and deaths caused
by pneumococcal pneumonia.Previous live, attenuated strains of S. pneumoniae were generated by deleting several highly immunogenic virulent
genes and therefore may not be optimal vaccine candidates. Some of these deletions include antigens that induce antibody responses following
pneumococcal carriage and otitis media in young children and therefore may not be optimal vaccine candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our technology in-licensed from St. Jude focuses
on candidate genes essential for microbial adaptation to the host environment while maintaining virulence determinants. The St. Jude researchers
developed a <I>S. pneumoniae strain</I> with a deletion in <I>ftsY</I>, a central component of the signal recognition pathway (SRP). SRP
mutants have greatly reduced virulence, although virulence factors are still produced. The <I>S. pneumoniae ftsY</I> deletion strain may
potentially make an ideal live attenuated vaccine, as it can transiently colonize the nasopharyngeal cavity without inducing immune responses
to virulence protein antigens but does not cause invasive disease.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our candidate vaccine is a live attenuated serotype-independent
vaccine, that early data supports further development to pursue a potential long-term preventive intranasal treatment. BWV-201 will likely
require two doses to provide life-long protection. BWV-201&rsquo;s has the ability to transiently colonize the nasopharyngeal cavity
and significantly decrease the incidence of AOM and sinusitis in animal models. The vaccine candidate is derived from the noninvasive
serotype 19F strain BHN97, which normally causes sinusitis/purulent rhinitis and AOM.&nbsp;As previously noted, the <I>ftsY</I> gene
was deleted by St. Jude researchers, and is designated BHN9<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">7<FONT STYLE="font-family: Symbol">&Auml;</FONT>fts</FONT>Y
(Rosch, Jason W et al. EMBO molecular medicine vol. 6,1 (2014):&nbsp;141-54. Doi:10.1002/emmm.201202150).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are also exploring the potential for BWV-201
to present antigens from additional AOM-causing pathogens, such as non-typeable <I>Haemophilus influenzae</I> and <I>Moraxella catarrhalis</I>.
Based on preliminary data from St. Jude, we are able to present additional antigens and following intranasal vaccination with the new
construct, vaccinated mice generate antibodies to both non-typeable <I>Haemophilus influenzae</I> and <I>Moraxella catarrhalis</I>, in
addition to generating antibodies from various strains of <I>S. pneumoniae.</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine production is a straightforward approach,
utilizing the entire bacterium with purification and concentration steps only in the downstream process thereby significantly reducing
the time and cost of production compared to polysaccharide or conjugate vaccines.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Preclinical data colonization and invasiveness and Otitis Media/Sinusitis
Efficacy</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our pre-clinical data has shown encouraging results
from the research and development of BWV-201 as a potential intranasal delivered vaccine candidate. Multiple animal models have demonstrated
protection from AOM.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To demonstrate vaccine efficacy against AOM and
sinusitis, mice were immunized (prime and two boosts) with Prevnar 7 (PCV7), Prevnar 13 (PCV13), Pneumovax (PCV23), D39x and BHN197 caxP
and ftsY deletion mutants. Deletion of ftsY, a central component of the signal recognition particle (SRP) pathway show heightened sensitivity
to environmental stress and have greatly diminished virulence. Deletion of caxP, a calcium/magnesium transporter, renders host physiological
conditions in blood and mucosa toxic to the bacterium. BHN97ftsY serotype 19F is also characterized in PCV7, PCV13, and PCV23 (Rosch,
Jason W et al. EMBO molecular medicine vol. 6,1 (2014):&nbsp;141-54. Doi:10.1002/emmm.201202150).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This head-to-head preclinical study mice (n=25-31)
that were either vaccinated by mock or live attenuated with deletions of either type 2 or 19F backgrounds. This was challenged by bioluminescent
BMH97X twice daily for AOM and sinusitis. Histopathology was also used to analyze the ears of mice. Xenogen imaging PPV23 was used as
a negative control.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Two&nbsp;weeks following the second boost,
the bioluminescent strain BNH97x (type 19F), a serotype included in Prevnar 7, Pneumovax and BHN97ftsY (referred to as homologous
challenge) were introduced to the mice. Only BHN97&#8710;ftsY (BWV-201), and to a lesser extent Prevnar 7, showed significant
reduction in AOM and only BHN97&#8710;ftsY demonstrated significantly reduced sinusitis compared to mock infected animals. The
incidence of AOM was significantly (<I>p</I> &lt; 0.05 compared to mock) lower in BHN97&#8710;ftsY&nbsp;&mdash;&nbsp;vaccinated mice
(Figure&nbsp;A-below). Only BHN97&#8710;ftsY vaccine significantly decreased the incidence of sinusitis (<I>p</I> &lt; 0.05).
Measurement of luminescence at 24 and 72 h confirmed protection engendered by BHN97&#8710;ftsY.</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-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="image_010.jpg" ALT="Chart, bar chart&#10;&#10;Description automatically generated" STYLE="height: 228px; width: 263px"></FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Figure
7.</B> Vaccine protection against otitis media and sinusitis. Mice (n=25&nbsp;&ndash;&nbsp;31 per group, performed at least twice for
each group) were mock-vaccinated with PBS (Mock) or vaccinated with live attenuated vaccines deleted for caxP or ftsY on either a type2
(D39</FONT><FONT STYLE="font-family: Symbol">&Auml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">caxP, D39</FONT><FONT STYLE="font-family: Symbol">&Auml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">ftsY)
or type19F (BNH97</FONT><FONT STYLE="font-family: Symbol">&Auml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">caxP,
BNH97</FONT><FONT STYLE="font-family: Symbol">&Auml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">ftsY) background.
Mice were challenged with a bioluminescent <I>S. pneumoniae</I> strain BNH97X (type19F) and imaged twice daily for development of AOM
or sinusitis. A.&nbsp;The proportion of mice developing an infection of the ear or sinus by Xenogen imaging. * =p&lt;0.05 by Chi-squared
test compared to the mock vaccinated group. PPV23 was used as a negative control (60% otitis and 80% sinusitis). Errors bars represent
standard error of the mean. PCV7 is Prevnar 7, PPV23 is Pneumovax and BHN97<FONT STYLE="font-family: Symbol">&Auml;</FONT>ftsY is BWV-201.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif">To
determine if BHN97</FONT><FONT STYLE="font-family: Symbol">&Auml;</FONT><FONT STYLE="font-family: Times New Roman, Times, Serif">ftsY,
or BWV-201, (serotype 19F) can induce heterotypic AOM protection (AOM caused by a <I>S. pneumoniae </I>serotype not contained in the
vaccine), mice (n=20) were immunized as detailed above and challenged with BHN54 (serotype 7), which causes otitis media in about 50%
of challenged animals. The control vaccine Prevnar 13 contains serotype 7; therefore, this study compares heterotypic (BHN97&#8710;ftsY) versus
homotypic (Prevnar 13) vaccine protection. BHN97&#9744;ftsY had a 10-fold lower incidence of AOM, (*p &lt; 0.05) when compared to mock
immunized animals, demonstrating that the attenuated vaccine does induce heterotypic protection. Bioluminescent signaling as well as,
reduction in weight loss also demonstrated secondary analysis supporting vaccine protection.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">BHN97&#8710;ftsY induced protection from AOM was
additionally confirmed in a chinchilla (n=20) animal model. The animals were immunized (prime and two boosts) and then challenged with
BHN97 two&nbsp;weeks after the final boost. Vaccinated animals had a decreased incidence of culture-positive ears and had a significantly
decreased number of recoverable bacteria from the middle ear (A). Following vaccination, a reduction in the number of culture positive
ears in vaccinated group compared to the mock animals was observed (B)&nbsp;as well as significant reduction in recoverable CFUs from
middle ear 7&nbsp;days post challenge (C)&nbsp;* = p &lt; 0.05 by Mann&nbsp;&mdash;&nbsp;Whitney.</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: center"></P>

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<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-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><IMG SRC="image_011.jpg" ALT="Chart&#10;&#10;Description automatically generated" STYLE="height: 750px; width: 400px"></FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 8. </B>Vaccine protection in a chinchilla
model of otitis media. The BHN97strain is capable of causing otitis media in chinchillas via intranasal administration as observed by
recoverable bacterial colony forming units (CFUs) from the middle ear (A)&nbsp;following challenge. B, C Following vaccination with BHN97
&#8710;ftsY (BWV-201), a reduction in the number of culture positive ears in the vaccinated group compared to the mock animals was observed
(B)&nbsp;as well as a significant reduction in recoverable CFUs from the middle ear at 7days post challenge (C). *&nbsp;=p&lt;0.05by Mann&nbsp;&mdash;&nbsp;Whitney.
Vaccine is BHN97 &#8710;ftsY (BWV-201).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A potential advantage of an attenuated <I>S. pneumoniae
</I>vaccine such as BHN97&#8710;ftsY is that immune responses are directed to bacterial proteins rather than just polysaccharides and
should not be limited to serotype specific protection. Purified polysaccharide (PPV) vaccines such as Pneumovax (produced by Merck&nbsp;&amp;Co.)
and pneumococcal conjugate vaccines such as Prevnar 7/13/20 (produced by Wyeth/Pfizer) or Synflorix (produced by GlaxoSmithKline plc)
are generally considered serotype specific, inducing protection to disease caused only by pneumococcal strains contained in the vaccines.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-301 Norovirus-Rotavirus Vaccine Program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing BWV-201 to prevent acute gastroenteritis,
or AGE, caused by norovirus and rotavirus, utilizing the P<SUB>24</SUB> nanoparticle of our vaccine platform. The vaccine is based on
one or two doses of the norovirus P<SUB>24</SUB> nanoparticle presenting 24 rotavirus VP8* antigens. Most cases of gastroenteritis are
caused by viruses. The CDC reports that viral gastroenteritis infections cause 200,000 deaths in children worldwide each year. Common
symptoms of viral gastroenteritis causes nausea, vomiting, diarrhea, anorexia, weight loss, and dehydration.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Gastroenteritis, often called stomach flu, is
inflammation of the gastrointestinal tract&nbsp;&mdash;&nbsp;the stomach and intestine. Symptoms may include diarrhea, vomiting and abdominal
pain. Fever, lack of energy and dehydration may also occur. While gastroenteritis is usually caused by viruses, bacteria, parasites, and
fungus can also cause gastroenteritis. Eating improperly prepared food, drinking contaminated water or close contact with a person who
is infected can spread the disease. Norovirus and rotavirus are two viruses that cause gastroenteritis in adults and children.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In 2015, there were two billion cases of gastroenteritis,
resulting in 1.3&nbsp;million deaths globally. Children and those in the developing world are affected the most. In 2011, there were about
1.7&nbsp;billion cases, resulting in about 700,000 deaths of children under the age of five. In the developing world, children less than
two&nbsp;years of age frequently get six or more infections a year. It is less common in adults, partly due to the development of immunity.
In adults, norovirus is the most common cause of severe disease. Rotavirus, however, is the common cause of AGE in children.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Norovirus causes significant debilitating AGE,
with a reported 700&nbsp;million infections and 20% of all diarrheal cases reported annually worldwide, according to the CDC.&nbsp;About
200&nbsp;million cases are seen among children under 5&nbsp;years old, leading to an estimated 50,000 child deaths every year. Norovirus
is the cause of approximately 20% of all AGE cases worldwide each year. It is estimated that 68.9 cases of norovirus infection occur in
every 1000 people. In North America, norovirus induced AGE tends to be seasonal, occurring in cooler, rainy&nbsp;months and particularly
impacts groups in close proximity, such as in schools, dormitories, medical facilities, and cruise ships.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Norovirus costs $60.3&nbsp;billion worldwide each
year (CDC). Globally, norovirus resulted in a total of approximately $4.2&nbsp;billion in direct health system costs and approximately
$60.3&nbsp;billion in societal costs per year. Disease among children younger than 5&nbsp;years cost society $39.8&nbsp;billion, compared
to $20.4&nbsp;billion for all other age groups combined. Costs per norovirus illness varied by both region and age and was highest among
adults ages 55&nbsp;years and older. Productivity losses represented&nbsp;84-99% of total costs varying by region. While low and middle
income countries and high income countries had similar disease incidence (10,148 vs. 9,935 illness per 100,000 persons), high income countries
generated 62% of global health system costs (Bartsch et al. PloS One 2016; 11:e0151219).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In North America, the median yearly cost of outbreaks
was $7.6&nbsp;million in direct medical costs, and $165.3&nbsp;million in productivity losses. An average of approximately 113,000 hospitalizations,
8.2-122.9&nbsp;million missed school/work&nbsp;days, $0.2-$2.3&nbsp;billion in direct medical costs, and $1.4-$20.7&nbsp;billion in productivity
losses was due to sporadic illness. The total economic impact of norovirus infection was $10.6&nbsp;billion based on the current incidence
estimate 68.9 cases per 1000 population, or approximately $0.15&nbsp;million per person infected.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The total economic burden is greatest in young
children but the highest cost per illness is among older age groups in some regions. These large costs overwhelmingly are from productivity
losses resulting from acute illness. Low, middle, and high income countries all have a considerable economic burden, suggesting that norovirus
gastroenteritis is a truly global economic problem.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is not a norovirus vaccine on the market
presently. There are, however, a number of rotavirus vaccines currently marketed around the world. RotaTeq, owned by Merck, a live, oral
pentavalent vaccine and Rotarix, owned by GSK, a monovalent, human, live attenuated vaccine are recommended by the World Health Organization
(WHO) for global use in children and approved for use in the U.S., Canada and Europe. Other monovalent vaccines are available but only
approved for use in one country, either China, Vietnam or India.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">P<SUB>24</SUB> VLPs produced in <I>E. coli</I>
and norovirus VP1 VLPs produced in a baculovirus expression system were both demonstrated to elicit innate, humoral and cellular immunity
in a mouse model, indicating that both constructs have potential as norovirus virus candidates. In addition, when delivered intranasally
both constructs were able to induce partial cross-variant protection against diarrhea in a gnotobiotic pig model. Ramesh et al. <I>Vaccines</I>
2019, 7, 777.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Rotavirus is the most common cause of diarrheal
disease among infants and young children, causing an estimated 111&nbsp;million episodes of diarrhea annually, 2&nbsp;million hospitalizations
and 352,000-592,000 deaths annually, according to the CDC.&nbsp;After the introduction of live attenuated oral vaccines the incidence
of rotaviral hospitalizations and deaths have significantly declined. However, there is still a need for efficacious, cost-effective rotavirus
vaccines.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The rotavirus vaccine is recommended by the CDC
and ACIP as a prevention for children. However, managing the symptoms is the only way to help adults and children infected with either
of the viruses. Due to the potential of death, most treatments are focused on dehydration prevention and management. Treatment involves
getting enough fluids. For mild or moderate cases, this can typically be achieved by drinking oral rehydration solution (a combination
of water, salts and sugar). In those who are breastfed, continued breastfeeding is recommended. For more severe cases, intravenous fluids
may be needed and care provided in the hospital. Fluids may also be given by a nasogastric tube. Zinc supplementation is recommended in
children. Antibiotics are generally not needed. However, antibiotics are recommended for young children with a fever and bloody diarrhea.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To determine the potential of the P<SUB>24</SUB>
VLP to serve as a rotavirus vaccine candidate, the 159&nbsp;amino acid VP8* protein was inserted into a P<SUB>24</SUB> domain surface
loop. The fusion proteins self-assembled into P<SUB>24</SUB> VLPs, and the 24 rotavirus VP8* antigens were demonstrated by cryo-EM to
be displayed on the outermost surface of the chimeric P<SUB>24</SUB> VLP.&nbsp;Mice (n-5-7) immunized intranasally with the P<SUB>24</SUB>-VP8*
or intramuscularly with Freund&rsquo;s adjuvant elicited significantly higher rotavirus neutralizing antibodies than the free VP8* immunized
under the same conditions (IN or IM). (P &gt;0.05), (Tan et al. J.&nbsp;Virol. 85(2):753-764. 2011.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">P<SUB>24</SUB>-VP8* VLPs were further characterized
as a potential rotavirus vaccine in mouse and gnotobiotic pig challenge studies. A construct consisting of P<SUB>24</SUB> and the VP8*
antigen from the murine rotavirus EDIM strain was constructed and tested using a murine rotavirus challenge model. Mice (n=5-7) were immunized
with P<SUB>24</SUB>-mouseVP8*, mouseVP8* alone or P<SUB>24</SUB>-human VP8* 3 times intranasally without adjuvant. Rotavirus shedding
was significantly lower in animals immunized with P<SUB>24</SUB>-mouseVP8* than mock vaccinated or animals that received mouseVP8* only
or P<SUB>24</SUB>-humanVP8* * (P &gt;0.05) (Tan et al. J.&nbsp;Virol. 85(2):753-764. 2011).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, an immunogenicity study was conducted
in gnotobiotic pigs (n=25). A construct of P<SUB>24</SUB> and the VP8* antigen corresponding to human rotavirus Wa strain was tested in
a gnotobiotic pig challenge model. Animals were immunized intramuscularly (IM) three times with either P<SUB>24</SUB>-WuVP8* with luminium
hydroxide adjuvant or luminium hydroxide alone and were challenged with human Wa rotavirus 7&nbsp;days post dose three. Animals immunized
with P<SUB>24</SUB>-WuVP8* showed a significant reduction in the mean duration of diarrhea, virus shedding and significantly lower fecal
cumulative consistency scores compared to adjuvant only control group (*, p &lt; 0.05; **, p &lt; 0.01). (Ramesh et al. Vaccines 7: 177
2019; doi:10.3390/vaccines7040177).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><B><IMG SRC="image_012.jpg" ALT="Chart&#10;&#10;Description automatically generated" STYLE="height: 615px; width: 600px"></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 9. </B>.P24-VP8* vaccine protected against
VirHRV diarrhea and reduced overall virus shed among vaccinated pigs. Fecal consistency (A)&nbsp;and virus shedding (B)&nbsp;were monitored
daily from post challenge&nbsp;day (PCD) 1 to PCD 7 after the challenge with VirHRV.&nbsp;Fecal consistency scores&ge;2 were considered
to be diarrheic (dashed line indicates the threshold of diarrhea). Statistical significance between vaccinated and control groups, determined
by multiple t tests, are indicated by asterisks (*,p&lt;0.05; **,p&lt;0.01).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, serum samples were collected from
the pigs at the times of P<SUB>24</SUB>-VP8* vaccine administration (PID&nbsp;0, PID&nbsp;10, PID21 and PID&nbsp;21) and VirHRV challenge
(PID&nbsp;27) and upon euthanasia (PCD 7). The P<SUB>24</SUB>-VP8* vaccine was highly immunogenic in Gn pigs. It induced strong VP8*-specific
serum IgG and Wa-specific virus-neutralizing antibody responses from post-inoculation&nbsp;day 21 to PCD 7. Comparisons between groups
at the same time points were carried out using Student&rsquo;s t-test and significant differences are identified by *** (n = 10&nbsp;&ndash;&nbsp;15;
p &lt; 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group, where different capital letters
(A, B, C,D) indicate a significant difference, p &lt; 0.01, and shared letters indicate no significant difference. These findings support
further investigation of the noro-rotavirus dual nanoparticle vaccine. (Ramesh et al. Vaccines 7: 177 2019; doi:10.3390/vaccines7040177)</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: center"></P>

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<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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_012.jpg" ALT=""></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 10. </B>Geometric mean VP8*-specific
IgG (A)&nbsp;and IgA (B)&nbsp;and Wa-HRV neutralizing (C)&nbsp;antibody titers in serum collected from Gn pigs at PID&nbsp;0, 10, 21,
28, and PCD 7. Pigs were vaccinated with P24-VP8* vaccine or Al(OH)3 adjuvant only. Each serum specimen was tested at an initial dilution
of 1:4. Negative samples were assigned an arbitrary value of 2 for calculation and graphical illustration purposes. Comparisons between
groups at the same time points were carried out using Student&rsquo;s t-test and significant differences are identified by&nbsp;*** (n
= 10&nbsp;&ndash;&nbsp;15; p &lt; 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group,
where different capital letters (A, B, C, D) indicate a significant difference, p &lt; 0.01, and shared letters indicate no significant
difference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">An effective norovirus culture-based neutralization
assay is not available, due to the lack of an efficient cell culture system to produce human norovirus. Therefore, a surrogate neutralization
assay has been developed in the field, measuring the ability of antisera to block norovirus VLP binding to host receptors. In addition
to generating rotavirus neutralizing antibody, Tan et al (J.&nbsp;Virol. 86:753-764. 2011) demonstrated that anti- P<SUB>24</SUB>-VP8*
mouse sera blocked norovirus VLP binding, indicating that the insertion of the VP8* fragment did not inhibit induction of norovirus VLP
binding antibodies and suggesting the P<SUB>24</SUB>-VP8 construct could potentially serve as a single vaccine against both rotavirus
and norovirus disease (P &gt;0.05).</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We hold the exclusive global license for the novel
norovirus-rotavirus combination vaccine (except in China and Hong&nbsp;Kong) from Cincinnati Children&rsquo;s Hospital Medical Center,
or CHMC, CHMC researchers engineered the norovirus major structural protein VP1 such that the N-terminal shell (S)&nbsp;and C-terminal
protruding (P)&nbsp;domains of VPI could be expressed as separate S<SUB>60</SUB> and P<SUB>24</SUB> virus-like particles (VLPs). Unlike
norovirus VLPs composed of the intact VP1 protein or the unmodified S<SUB>60</SUB> fragment, our S<SUB>60</SUB> and P<SUB>24</SUB>VLPs
can be expressed in <I>E. coli</I>. The researchers demonstrated that S<SUB>60</SUB> VLPs could be used to present foreign antigens on
the surface of the S<SUB>60</SUB> VLP.&nbsp;Further, it has also demonstrated that foreign antigens could also be expressed on the surface
of the P<SUB>24</SUB> VLP.&nbsp;The proposed norovirus-rotavirus vaccine is based on the P<SUB>24</SUB> VLP technology. Our vaccine production
is based on an <I>E.coli</I> expression platform.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Following IND submission, if accepted, we intend
to initiate our Phase&nbsp;I clinical trial in healthy adults ages&nbsp;18&nbsp;to 54. If approved, we believe our vaccine is well positioned
to receive a recommendation from the CDC, ACIP, and similar international advisory groups for inclusion in vaccine programs.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-302: Norovirus-malaria vaccine program</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, we are currently investigating a
malaria vaccine, BWV-302, utilizing our norovirus platform. The vaccine is designed to offer protection from both norovirus and malaria,
infectious diseases that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of
the plasmodium parasite being presented on the surface of the norovirus nanoparticle.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Malaria can be a deadly disease caused by
protozoan parasites from the Plasmodium family, primarily spread by mosquitos (CDC, <I>https://wwwnc.cdc.gov/travel/diseases/malaria)</I>.
Malaria may also, at times, be transmitted through blood transfusion, organ transplantation and from mother to fetus. (CDC, <I>https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/malaria</I>).
While transmission through blood transfusion is rare in the U.S., there are no approved blood tests currently available to screen
blood donation for malaria. There were approximately 219&nbsp;million cases of malaria reported in 2019 globally, resulting in
approximately 409,000 deaths, of which approximately 67% were children. (WHO, <I>https://www.who.int/news-room/fact-sheets/detail/malaria</I>).
Symptoms of malaria normally manifest themselves within 7 to 10&nbsp;days of exposure, and can at times, be mistaken for other
illnesses, including influenza. Severe malaria is life-threatening and can cause multi-organ failure in adults and severe anemia,
metabolic acidosis and cerebral malaria in children. The World Health Organization estimates that almost half of the global
population is at risk of contracting malaria. Infants, children under 5&nbsp;years of age, pregnant women and immune compromised
individuals are highest risk of developing the disease. Additionally, non-immune migrants, mobile populations and travelers are at
risk of developing severe disease. Neurological issues in children may continue to persist after cerebral malaria, including ataxia,
palsy, speech impairment, deafness and blindness.</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: center"></P>

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<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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_014.jpg" ALT="">&nbsp;</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-indent: 0.25in">More than 100 species of Plasmodium have been
identified. Four of the species have been recognized as naturally infecting humans, while one that infects macaques and has been identified
as a cause of zoonotic malaria. In rare cases, additional species may infect humans. The primary four parasites that cause human infection
are <I>P.&nbsp;falciparum, P. vivax, P. ovale and</I> (<I>https://www.cdc.gov/malaria/about/biology/index.html</I>). <I>P. knowlesi</I>
is naturally occurring in macaques in Southeast Asia and has recently been reported as the cause zoonotic malaria, especially in Malaysia.
<I>P. falciparum </I>is found world-wide, can cause severe malaria and is the predominate human malaria causing species around the world.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is currently one vaccine for malaria, RTS,S/AS01
(MVI-GSK) targeting the falciparum CS protein, which received a positive opinion from the European Medicines Agency (EMA) for use outside
of the European Union in infants 6&nbsp;weeks of age and older. (<I>https://www.ema.europa.eu/en/news/first-malaria-vaccine-receives-positive-scientific-opinion-ema</I>)
According to the EMA, the World Health Organization and the relevant regulatory agencies for countries outside of the European Union can
authorize its use. The vaccine is currently being administered to infants and children in parts of Africa within high transmission regions.
The vaccine&rsquo;s efficacy appears to wane after five&nbsp;years (Laurens MB.&nbsp;RTS,S/AS01 vaccine (Mosquirix&trade;): an overview.
<I>Hum Vaccin Immunother.</I> 2020;16(3):480-489. Doi:10.1080/21645515.2019.1669415). The recommended course of action for preventing
malaria is prevention of mosquito bites, and for those most vulnerable, a preventative treatment with sulfadoxine-pyrimethamine, especially
in high transmission areas (WHO). In certain regions, the WHO has recommended the addition of amodiaquine to children under 5&nbsp;years
of age monthly during the high transmission season, along with sulfadoxine-pyrimethamine. Many regions employ mosquito control measures
to reduce mosquito populations, however, 73 countries have reported mosquito resistance to at least 1 of the 4 most commonly used insecticides,
while 23 countries have reported mosquito resistance to all of the commonly used insecticides.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once malaria is diagnosed, the two most common
treatments are Chloroquine phosphate and Artemisinin-based combination (ACT) therapies. Chloroquine is the preferred treatment, however,
some malaria parasites have become resistant to chloroquine and it may not be an effective treatment. ACT is a combination of two or more
drugs that work against the malaria parasite in different ways. This is usually the preferred treatment for chloroquine-resistant malaria.
However, as recently reported in Nature Medicine, there is growing concern about Artemisinin&nbsp;&mdash;&nbsp;derivative resistant P.falciparum
in the Greater Mekong subregion (Cambodia, Thailand, Vietnam, Myanmar and Laos) (<I>https://www.nature.com/articles/s41591-020-1005-2.pdf</I>).
Previous occurrences of resistant strains also first appeared in the Greater Mekong subregion and then spread to other parts of the world.
(<I>https://www.nature.com/articles/s41591-020-1005-2.pdf</I>).</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We hold the exclusive global license for the novel
norovirus-malaria combination vaccine from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC, CHMC researchers engineered the
norovirus major structural protein VP1 such that the N-terminal shell (S)&nbsp;and C-terminal protruding (P)&nbsp;domains of VPI could
be expressed as separate S<SUB>60</SUB> and P<SUB>24</SUB> virus-like particles (VLPs). Unlike norovirus VLPs composed of the intact VP1
protein or the unmodified S<SUB>60</SUB> fragment, our S<SUB>60</SUB> and P<SUB>24</SUB>VLPs can be expressed in <I>E. coli</I>. The researchers,
Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., demonstrated that S<SUB>60</SUB> VLPs could be used to present foreign antigens on the surface
of the S<SUB>60</SUB> VLP.&nbsp;Further, it has also demonstrated that foreign antigens could also be expressed on the surface of the
P<SUB>24</SUB> VLP. (see <B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B>). The proposed norovirus-malaria
vaccine, P-CS)TSR is based on the P<SUB>24</SUB> VLP technology. Our vaccine production is based on an <I>E.coli</I> expression platform.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The circumsporozoite (CS) protein is the major
surface component of <I>P. falciparum</I> sporozoites and is essential for host cell invasion. Our vaccine, developed by Jiang and Ming
from CHMC, combines a small domain of the CS protein with the norovirus P<SUB>24</SUB> particle creating a chimeric nanoparticle capable
of eliciting an immune response. A mouse immunization study was conducted using the P<SUB>24</SUB> particle presenting the small domain
of the CS protein. Mice (n=16) were immunized three times with the chimeric nanoparticle using aluminum hydroxide as an adjuvant, 3D7-His,
3D7-GST and PBS.&nbsp;Sera was collected and evaluated.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">High antibody titers, as determined by ELISA,
were observed after the second immunization and higher titers were observed after the third immunization. The antibodies were also shown
to recognize the plasmodium falciparum 3D7 strain using immunofluorescence assays. These data demonstrate the potential of our vaccine
candidate against malaria. We expect to conduct an animal challenge study to further analyze the protective nature of BWV-302 and support
an IND application.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 3. Mouse malaria antibody titer post-immunization</B></P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 50%; border-bottom: black 1.5pt solid; padding-right: 3pt; font-size: 10pt"><B>Antibody titer after 2<SUP>nd</SUP> immunization</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>Antibody titer after 3<SUP>rd</SUP> immunization</B></TD></TR>
  </TABLE>
<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-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;<IMG SRC="image_015.jpg" ALT=""></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 11. IFA of plasmodium sporozoites (3D7)
stained with anti-P<SUB>24</SUB> particle presenting the small domain of the CS protein mouse sera</B></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-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_016.jpg" ALT=""></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: center"></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We anticipate conducting an animal challenge study
for BWV-302 in the second half of 2023. Upon completion, the technology will be transferred to a partner CDMO for process optimization,
GMP production and toxicology studies, as well as other studies required by the FDA for IND submission, currently anticipated for the
second half of 2022. Following IND submission immediately upon completion of the toxicology study, if successful, we intend to initiate
our Phase&nbsp;I clinical trial in healthy adults ages 18 to 54 upon acceptance by the FDA.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Government Regulation and Product Approval</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA and other regulatory authorities at federal,
state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those we are developing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Small molecule drugs are subject to regulation
under the Food, Drug, and Cosmetic Act, or FDCA, and biological products are additionally subject to regulation under the Public Health
Service Act, or PHSA, and both are subject to additional federal, state, local and foreign statutes and regulations. We, along with third-party
contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory
agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>United&nbsp;States</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>U.&nbsp;S. Biopharmaceuticals Regulation</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The process required by the FDA before drug and
biologic product candidates may be marketed in the United&nbsp;States generally involves the following:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">completion of extensive preclinical laboratory tests and
animal studies performed in accordance with applicable regulations, including the FDA&rsquo;s Good Laboratory Practice, or GLP, regulations;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">submission to the FDA of an investigational new drug application,
IND, which must become effective before clinical trials may begin;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">approval by an independent institutional review board or
ethics committee at each clinical site before the trial is commenced;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">performance of adequate and well-controlled human clinical
trials in accordance with FDA&rsquo;s Good Clinical Practice, or GCP, regulations to establish the safety and efficacy of a drug candidate
and safety, purity and potency of a proposed biologic product candidate for its intended purpose;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">preparation of and submission to the FDA of a new drug application,
or NDA, or biologics license application, or BLA, as applicable, after completion of all pivotal clinical trials;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">satisfactory completion of an FDA Advisory Committee review,
if applicable;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">a determination by the FDA within 60&nbsp;days of its receipt
of an NDA or BLA to file the application for review;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">satisfactory completion of an FDA pre-approval inspection
of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing
Practice requirements, or cGMPs, and of selected clinical investigation sites to assess compliance with GCPs; and</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">FDA review and approval of an NDA, or licensure of a BLA,
to permit commercial marketing of the product for particular indications for use in the United&nbsp;States.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Preclinical and Clinical Development</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to beginning the first clinical trial with
a product candidate, we must submit an IND to the FDA.&nbsp;An IND is a request for authorization from the FDA to administer an investigational
new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol or protocols
for preclinical studies and clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics,
pharmacology and harmacodynamics characteristics of the product, chemistry, manufacturing and controls information, and any available
human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials
may begin. The IND automatically becomes effective 30&nbsp;days after receipt by the FDA, unless the FDA, within the 30-day period, raises
safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor
and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may
or may not result in FDA authorization to begin a clinical trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials involve the administration of
the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include
the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials
are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety
and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial
conducted during product development and for any subsequent protocol amendments. Furthermore, an independent institutional review board
for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent
form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the institutional
review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being
exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight
by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides
authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and
may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration
of efficacy.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For purposes of biopharmaceutical development,
human clinical trials are typically conducted in three sequential phases that may overlap or be combined;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>&#9679;</I></TD><TD STYLE="text-align: left"><I>Phase&nbsp;1. </I>The investigational product is initially introduced into patients with the
                                                                                             target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and
                                                                                             distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain
                                                                                             early evidence on effectiveness.</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>&#9679;</I></TD><TD STYLE="text-align: left"><I>Phase&nbsp;2. </I>The investigational product is administered to a limited patient population to
                                                                                             evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety
                                                                                             risks.</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left"><I>Phase&nbsp;3. </I>The investigational product is administered to an expanded patient population
                                                                                      to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety,
                                                                                      generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall
                                                                                      risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In some cases, the FDA may require, or companies
may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called
Phase&nbsp;4 studies may be made a condition to approval of the application. Concurrent with clinical trials, companies may complete additional
animal studies and develop additional information about the characteristics of the product candidate and must 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, must develop methods for testing the identity, strength, quality and
purity of the final product, or for biologics, the safety, purity and potency. 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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">During all phases of clinical development, regulatory
agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. The FDA
or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that
the research patients or patients are being exposed to an unacceptable health risk. Similarly, an institutional review board can suspend
or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the institutional
review board&rsquo;s requirements or if the biological product candidate has been associated with unexpected serious harm to patients.
There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
Sponsors of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information, which
is publicly available at <I>www.clinicaltrials.gov</I>.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>NDA/BLA Submission and Review</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Assuming successful completion of all required
testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical
trials are submitted to the FDA as part of an NDA or BLA, as applicable, requesting approval to market the product for one or more indications.
The application must include all relevant data available from pertinent preclinical studies and clinical trials, including negative or
ambiguous results as well as positive findings, together with detailed information relating to the product&rsquo;s chemistry, manufacturing,
controls, and proposed labeling, among other things. The submission of an application requires payment of a substantial application user
fee to the FDA, unless a waiver or exemption applies. The FDA has sixty&nbsp;days from the applicant&rsquo;s submission to either issue
a refusal to file letter or accept the application for filing, indicating that it is sufficiently complete to permit substantive review.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once an NDA or BLA has been accepted for filing,
the FDA&rsquo;s goal is to review standard applications within 10&nbsp;months after it accepts the application for filing, or, if the
application qualifies for priority review, six&nbsp;months after the FDA accepts the application for filing. In both standard and priority
reviews, the review process is often significantly extended by FDA requests for additional information or clarification. The FDA reviews
an NDA to determine whether a drug is safe and effective for its intended use and a BLA to determine whether a biologic is safe, pure
and potent. FDA also reviews whether the facility in which the product is manufactured, processed, packed or held meets standards designed
to assure and preserve the product&rsquo;s identity, safety, strength, quality, potency and purity. The FDA may convene an advisory committee
to provide clinical insight on application review questions. Before approving an NDA or BLA, the FDA will typically inspect the facility
or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Additionally, before approving an application, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs.
If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the
deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested
additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">After the FDA evaluates an application and conducts
inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may
issue an approval letter or a Complete Response letter. An approval letter authorizes commercial marketing of the product with specific
prescribing information for specific indications. A Complete Response letter will describe all of the deficiencies that the FDA has identified
in the application, except that where the FDA determines that the data supporting the application are inadequate to support approval,
the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted product lots and/or reviewing
proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant might take to place the application
in condition for approval, including requests for additional information or clarification, which may include the potential requirement
for additional clinical studies. The FDA may delay or refuse approval of an application if applicable regulatory criteria are not satisfied,
require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If regulatory approval of a product is granted,
such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be
marketed. For example, the FDA may approve the application with a risk evaluation and mitigation strategy, or REMS, to ensure the benefits
of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and
to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician
communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization
tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls
and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is
not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase&nbsp;4 post-market
studies and surveillance to further assess and monitor the product&rsquo;s safety and effectiveness after commercialization, and may limit
further marketing of the product based on the results of these post-marketing studies.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Expedited Development and Review Programs</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA offers a number of expedited development
and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing
new products that meet certain criteria. Specifically, new products are eligible for fast track designation if they are intended to treat
a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor
of a fast track product has opportunities for frequent interactions with the review team during product development and, once an NDA or
BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where
the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor
provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines
that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A product intended to treat a serious or life-threatening
disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product can receive
breakthrough therapy designation if preliminary clinical evidence indicates that the product, alone or in combination with one or more
other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,
such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features,
as well as more intensive FDA interaction and guidance beginning as early as Phase&nbsp;1 and an organizational commitment to expedite
the development and review of the product, including involvement of senior managers.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any marketing application for a drug or biologic
submitted to the FDA for approval, including a product with a fast track designation and/or breakthrough therapy designation, may be eligible
for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval.
A product is eligible for priority review if it has the potential to provide a significant improvement in the treatment, diagnosis or
prevention of a serious disease or condition. Priority review designation means the FDA&rsquo;s goal is to take action on the marketing
application within six&nbsp;months of the 60-day filing date.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, products studied for their safety
and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination
that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint
that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible
morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability
or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate
and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality
or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional
materials, which could adversely impact the timing of the commercial launch of the product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Fast track designation, breakthrough therapy designation
and priority review do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies
for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide
that the time period for FDA review or approval will not be shortened.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Orphan Drug Act, the FDA may grant orphan
designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than
200,000 individuals in the United&nbsp;States, or more than 200,000 individuals in the United&nbsp;States for which there is no reasonable
expectation that the cost of developing and making available in the United&nbsp;States a drug or biologic for this type of disease or
condition will be recovered from sales in the United&nbsp;States for that drug or biologic. Orphan drug designation must be requested
before submitting an NDA or BLA.&nbsp;After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and
its potential orphan use are disclosed publicly by the FDA.&nbsp;The orphan drug designation does not convey any advantage in, or shorten
the duration of, the regulatory review or approval process.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If a product that has orphan drug designation
subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug
exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full NDA or BLA, to
market the same drug or biologic for the same indication for seven&nbsp;years, except in limited circumstances, such as a showing of clinical
superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown
that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition
for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the
same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug
designation are tax credits for certain research and a waiver of the NDA or BLA application fee.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A designated orphan drug may not receive orphan
drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition,
exclusive marketing rights in the United&nbsp;States may be lost if the FDA later determines that the request for designation was materially
defective.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Post-Approval Requirements</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any products manufactured or distributed by us
pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating
to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion
of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject
to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee
for each product identified in an approved NDA or BLA.&nbsp;Biopharmaceutical manufacturers and their subcontractors 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 cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval
before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting
requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time,
money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA may withdraw 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 revisions to the approved labeling to add new safety information; imposition
of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions
under a REMS program. Other potential consequences include, among other things:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">restrictions on the marketing or manufacturing of a product,
complete withdrawal of the product from the market or product recalls;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">fines, warning or untitled letters or holds on post-approval
clinical studies;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">refusal of the FDA to approve pending applications or supplements
to approved applications, or suspension or revocation of existing product approvals;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">product seizure or detention, or refusal of the FDA to permit
the import or export of products;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">consent decrees, corporate integrity agreements, debarment
or exclusion from federal healthcare programs;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">mandated modification of promotional materials and labeling
and the issuance of corrective information;</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the issuance of safety alerts, Dear Healthcare Provider letters,
press releases and other communications containing warnings or other safety information about the product; or</TD>
</TR></TABLE>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">injunctions or the imposition of civil or criminal penalties.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA closely regulates the marketing, labelling,
advertising and promotion of biopharmaceutical products. A company can make only those claims relating to safety and efficacy, purity
and potency that are approved by the FDA and in accordance with the provisions of the approved label. However, companies may share truthful
and not misleading information that is otherwise consistent with a product&rsquo;s FDA approved labelling. The FDA and other agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result
in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians
may prescribe legally available products for uses that are not described in the product&rsquo;s labelling and that differ from those tested
by us and approved by the FDA.&nbsp;Such off-label uses are common across medical specialties. Physicians may believe that such off-label
uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice
of treatments. The FDA does, however, restrict manufacturer&rsquo;s communications on the subject of off-label use of their products.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>U.S.&nbsp;Market Exclusivity</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A biological product can obtain pediatric market
exclusivity in the U.S., which, if granted, adds six&nbsp;months to existing exclusivity periods, including some regulatory exclusivity
periods tied to patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may
be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued &ldquo;Written Request&rdquo; for such
a study.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Biologics Price Competition and Innovation
Act&nbsp;of&nbsp;2009, or BPCIA, created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable
with, an FDA-licensed reference biological product. This amendment to the PHSA attempts to minimize duplicative testing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Biosimilarity, which requires that there be no
clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can
be shown through analytical studies, animal studies, and a clinical trial or trials. Interchangeability requires that a product is biosimilar
to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference
product and, for products administered multiple times, the biologic and the reference biologic may be interchanged after one has been
previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
However, complexities associated with the larger, and often more complex, structure of biological products, as well as the process by
which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA will not accept an application for a biosimilar
or interchangeable product based on the reference biological product until four&nbsp;years after the date of first licensure of the reference
product, and the FDA will not approve an application for a biosimilar or interchangeable product based on the reference biological product
until 12&nbsp;years after the date of first licensure of the reference product. &ldquo;First licensure&rdquo; typically means the initial
date the particular product at issue was licensed in the U.S.&nbsp;Date of first licensure does not include the date of licensure of (and
a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product
or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or
other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication,
route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure
of the biological product that does not result in a change in safety, purity, or potency.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The BPCIA is complex and continues to be interpreted
and implemented by the FDA.&nbsp;In addition, government proposals have sought to reduce the 12-year reference product exclusivity period.
Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation.
As a result, the ultimate implementation and impact of the BPCIA is subject to significant uncertainty.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Pediatric Study Plan and Pediatric Exclusivity</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Pediatric Research Equity Act, as amended,
or the PREA, certain NDAs and certain NDA supplements must contain data that can be used to assess the safety and efficacy of the product
candidate 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. The PREA requires that a sponsor who is planning to submit a marketing application for a product candidate that includes a new
active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study
Plan, or the PSP, within 60&nbsp;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 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor
plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for
not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement
to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP.&nbsp;A
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 preclinical studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required
by regulation, the PREA does not apply to a drug for an indication for which orphan designation has been granted, except that the PREA
will apply to an original NDA for a new active ingredient that is orphan-designated if the drug is a molecularly targeted cancer product
intended for the treatment of an adult cancer and is directed at a molecular target that the FDA determines to be substantially relevant
to the growth or progression of a pediatric cancer.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A drug can also obtain pediatric market exclusivity
in the United&nbsp;States. Pediatric exclusivity, if granted, adds six&nbsp;months to existing exclusivity periods and patent terms. This
six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion
of a pediatric study in accordance with an FDA-issued &ldquo;Written Request&rdquo; for such a study.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Patent Term Restoration and Extension</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Depending upon the timing, duration and specifics
of the FDA approval of our product candidates, some of our U.S.&nbsp;patents may be eligible for limited patent term extension. The provisions
of the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, permit a patent restoration term
of up to five&nbsp;years as compensation for patent term lost during product development and the FDA regulatory review process. However,
patent term restoration cannot extend the remaining term of a patent beyond a total of 14&nbsp;years from the product&rsquo;s approval
date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of
a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved
product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The
USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future,
we may apply for restoration of patent term for one of our currently owned or licensed patents to add patent life beyond its current expiration
date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many other countries also provide for patent term
extensions or similar extensions of patent protection for biologic products. For example, in Japan, it may be possible to extend the patent
term for up to five&nbsp;years and in Europe, it may be possible to obtain a supplementary patent certificate that would effectively extend
patent protection for up to five&nbsp;years.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Federal and State Fraud and Abuse, Data Privacy and Security, and
Transparency Laws and Regulations</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to FDA restrictions on marketing of
pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry.
These laws may impact, among other things, our current and future business operations, including our clinical research activities, and
proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare
providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws
include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including,
without limitation, those laws described below.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;federal Anti-Kickback Statute prohibits
any person or entity from, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce
or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable
under Medicare, Medicaid or other federal healthcare programs. The term &ldquo;remuneration&rdquo; has been broadly interpreted to include
anything of value. The U.S.&nbsp;federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions and
regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices
that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny
if they do not qualify for an exception or safe harbor. Several courts have interpreted the statute&rsquo;s intent requirement to mean
that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute
has been violated.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A person or entity does not need to have actual
knowledge of this 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 U.S.&nbsp;federal Anti-Kickback Statute constitutes a false
or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary penalties laws.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Federal civil and criminal false claims laws and
civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower
and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false
claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material
to a false or fraudulent claim to the federal government. A claim includes &ldquo;any request or demand&rdquo; for money or property presented
to the U.S.&nbsp;government. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly
providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies
have been prosecuted for causing false claims to be submitted because of the companies&rsquo; marketing of products for unapproved, and
thus non-reimbursable, uses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The federal Health Insurance Portability and Accountability
Act&nbsp;of&nbsp;1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully
executing a scheme to defraud any healthcare benefit program, including private third-party payors 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. Also, many states have similar fraud and abuse statutes or regulations that
apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we may be subject to data privacy
and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health
Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose specified
requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable
health information. Among other things, HITECH makes HIPAA&rsquo;s security standards directly applicable to &ldquo;business associates,&rdquo;
defined as independent contractors or agents of covered entities, which include certain healthcare providers, healthcare clearinghouses
and health plans, that create, receive, maintain or transmit individually identifiable 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 attorney&rsquo;s fees and costs associated with pursuing federal civil actions.
In addition, state laws govern the privacy and security of health information in certain circumstances, many of which are not pre-empted
by HIPAA, differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The federal Physician Payments Sunshine Act requires
certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the
Children&rsquo;s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare&nbsp;&amp; Medicaid
Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable
manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians
and their immediate family members.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may also be subject to state laws that require
pharmaceutical companies to comply with the pharmaceutical industry&rsquo;s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the federal government, state laws that require drug manufacturers to report information related to payments and
other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing, and state and local laws
that require the registration of pharmaceutical sales representatives.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because of the breadth of these laws and the narrowness
of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to
challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described
above or any other governmental regulations that apply to us, we may be subject to significant criminal, civil and administrative penalties
including damages, fines, imprisonment, disgorgement, additional reporting requirements and oversight if we become subject to a corporate
integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm,
diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment
or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which
may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, implementation
of corporate compliance programs, reporting of payments or transfers of value to healthcare professionals, and additional data privacy
and security requirements.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Coverage and Reimbursement</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The future commercial success of our product candidates,
if approved, will depend in part on the extent to which third-party payors, such as governmental payor programs at the federal and state
levels, including Medicare and Medicaid, private health insurers and other third-party payors, provide coverage of and establish adequate
reimbursement levels for our product candidates. Third-party payors generally decide which products they will pay for and establish reimbursement
levels for those products. In particular, in the United&nbsp;States, no uniform policy for coverage and reimbursement exists. Private
health insurers and other third-party payors often provide coverage and reimbursement for products based on the level at which the government,
through the Medicare program, provides coverage and reimbursement for such products, but also on their own methods and approval process
apart from Medicare determinations. Therefore, coverage and reimbursement can differ significantly from payor to payor.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, the European Union,
or EU, and other potentially significant markets for our product candidates, government authorities and third-party payors are increasingly
attempting to limit or regulate the price of products, particularly for new and innovative products, which often has resulted in average
selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United&nbsp;States and
on country and regional pricing and reimbursement controls in the EU will put additional pressure on product pricing, reimbursement and
usage. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related
to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Third-party payors are increasingly imposing additional
requirements and restrictions on coverage and limiting reimbursement levels for products. For example, federal and state governments reimburse
products at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of products.
Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved
products for a particular indication. Similarly, because certain of our product candidates are physician-administered, separate reimbursement
for the product itself may or may not be available. Instead, the administering physician may only be reimbursed for providing the treatment
or procedure in which our product is used. Third-party payors are increasingly challenging the price and examining the medical necessity
and cost-effectiveness of products, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies
in order to demonstrate the medical necessity and cost-effectiveness of our product candidates, in addition to the costs required to obtain
the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor&rsquo;s decision to provide
coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-party payor reimbursement may
not be available to enable us to realize an appropriate return on our investment in product development. Legislative proposals to reform
healthcare or reduce costs under government insurance programs may result in lower reimbursement for our product candidates, if approved,
or exclusion of our product candidates from coverage and reimbursement. The cost containment measures that third-party payors and providers
are instituting and any healthcare reform could significantly reduce our revenue from the sale of any approved product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The United&nbsp;States and some foreign jurisdictions
are considering enacting or have enacted a number of additional legislative and regulatory proposals to change the healthcare system in
ways that could affect our ability to sell our product candidates profitably, if approved. Among policy makers and payors in the United&nbsp;States
and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare
costs, improving quality and expanding access. In the United&nbsp;States, the pharmaceutical industry has been a particular focus of these
efforts, which include major legislative initiatives to reduce the cost of care through changes in the healthcare system, including limits
on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded healthcare
programs, and increased governmental control of drug pricing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There have been several U.S.&nbsp;government initiatives
over the past few&nbsp;years to fund and incentivize certain comparative effectiveness research, including creation of the Patient-Centered
Outcomes Research Institute under the ACA.&nbsp;It is also possible that comparative effectiveness research demonstrating benefits in
a competitor&rsquo;s product could adversely affect the sales of our product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ACA became law in March&nbsp;2010 and substantially
changed the way healthcare is financed by third-party payors, and significantly impacts the U.S.&nbsp;pharmaceutical industry. Among other
measures that may have an impact on our business, the ACA established an annual, nondeductible fee on any entity that manufactures or
imports specified branded prescription drugs and biologic agents; a new Medicare Part&nbsp;D coverage gap discount program; and a new
formula that increased the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Additionally, the ACA extended manufacturers&rsquo;
Medicaid rebate liability, expands eligibility criteria for Medicaid programs, and expanded entities eligible for discounts under the
Public Health Service Act. At this time, we are unsure of the full impact that the ACA will have on our business.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Since its enactment, there have been judicial
and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace
certain aspects of the ACA, and we expect such challenges and amendments to continue. Since January&nbsp;2017, President Trump has signed
two Executive Orders and other directives designed to delay the implementation of certain ACA provisions or otherwise circumvent requirements
for health insurance mandated by the ACA.&nbsp;Concurrently, Congress has considered legislation that would repeal or repeal and replace
all or part of the ACA.&nbsp;While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of
certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act&nbsp;of&nbsp;2017, or Tax Act, includes a provision that
repealed, effective January&nbsp;1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail
to maintain qualifying health coverage for all or part of a year that is commonly referred to as the &ldquo;individual mandate.&rdquo;
On January&nbsp;22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation
of certain ACA-mandated fees, including the so-called &ldquo;Cadillac&rdquo; tax on certain high cost employer-sponsored insurance plans,
the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on nonexempt medical
devices. The Bipartisan Budget Act&nbsp;of&nbsp;2018, or the BBA, among other things, amended the ACA, effective January&nbsp;1, 2019,
to increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part&nbsp;D
and to close the coverage gap in most Medicare drug plans, commonly referred to as the &ldquo;donut hole.&rdquo; In July&nbsp;2018, CMS
published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance
issuers under the ACA adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses
to determine this risk adjustment. In December&nbsp;2018, a U.S.&nbsp;District Court Judge in the Northern District of Texas, or Texas
District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was
repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well. While the Texas District Court Judge, as well
as the Trump administration and CMS, have stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent
appeals, and other efforts to repeal and replace the ACA will impact the ACA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, other legislative changes have been
proposed and adopted since the ACA was enacted. In August&nbsp;2011, the President signed into law the Budget Control Act&nbsp;of&nbsp;2011,
as amended, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began
in 2013 and, following passage of subsequent legislation, including the BBA, will continue through 2027 unless additional Congressional
action is taken. In January&nbsp;2013, the American Taxpayer Relief Act&nbsp;of&nbsp;2012 was enacted which, among other things, reduced
Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments
to providers from three to five&nbsp;years.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Further,
there has been increasing legislative and enforcement interest in the United&nbsp;States with respect to drug pricing practices. Specifically,
there have been several recent U.S.&nbsp;Congressional inquiries and proposed and enacted federal and state legislation designed to, among
other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and
reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration&rsquo;s budget proposal
for fiscal year 2019 contains further drug price control measures that could be enacted during the 2019 budget process or in other future
legislation. Additionally, the Trump administration released a &ldquo;Blueprint&rdquo; to lower drug prices and reduce out of pocket costs
of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare
programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid
by consumers. </FONT>In August&nbsp;2022, Congress passed the Inflation Reduction Act&nbsp;of&nbsp;2022, which included a provision allowing
Medicare to negotiate drug prices directly with pharmaceutical manufacturers. This provision may impact pricing strategies and determinations
in the future. <FONT STYLE="font-family: Times New Roman, Times, Serif">The U.S.&nbsp;Department of Health and Human Services, or HHS,
has already started the process of soliciting feedback on some of these measures and is implementing others under its existing authority.
For example, in September&nbsp;2018, CMS announced that it will allow Medicare Advantage plans the option to use step therapy for Part&nbsp;B
drugs beginning January&nbsp;1, 2019. On January&nbsp;31, 2019, the HHS Office of Inspector General proposed modifications to U.S.&nbsp;federal
Anti-Kickback Statute safe harbors which, among other things, may affect rebates paid by manufacturers to Medicare Part&nbsp;D plans,
the purpose of which is to further reduce the cost of drug products to consumers. In addition, CMS issued a final rule, effective on July&nbsp;9,
2019, that requires direct-to-consumer television advertisements of prescription drugs and biological products, for which payment is available
through or under Medicare or Medicaid, to include in the advertisement the Wholesale Acquisition Cost, or list price, of that drug or
biological product if it is equal to or greater than $35 for a monthly supply or usual course of treatment. Prescription drugs and biological
products that are in violation of these requirements will be included on a public list. Congress and the Trump administration have each
indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures
have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological 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 addition, regional healthcare
authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included
in their healthcare programs. Furthermore, there has been increased interest by third party payors and governmental authorities in reference
pricing systems and publication of discounts and list prices. These measures could reduce future demand for our products or put pressure
on our pricing.</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, in May&nbsp;2018, the Trickett Wendler,
Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act&nbsp;of&nbsp;2017, or the Right to Try Act, was signed into law.
The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that
have completed a Phase&nbsp;1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible
patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program.
There is no obligation for a drug manufacturer to make its drug products available to eligible patients as a result of the Right to Try
Act.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to market any product outside of the
United&nbsp;States, we would need to comply with numerous and varying regulatory requirements of other countries regarding safety and
efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product
candidates. For example, in the EU, we must obtain authorization of a clinical trial application, or CTA, in each member state in which
we intend to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals
by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those
countries. The approval process varies from country to country and can involve additional product testing and additional administrative
review periods. The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA
approval. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory
approval in one country may negatively impact the regulatory process in others.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Further, some countries outside of the United&nbsp;States,
including the EU member states, Switzerland and the United Kingdom, have also adopted data protection laws and regulations, which impose
significant compliance obligations. In the EU, the collection and use of personal health data is governed by the provisions of the General
Data Protection Regulation, or GDPR.&nbsp;The GDPR became effective on May&nbsp;25, 2018, repealing its predecessor directive and increasing
responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects. The GDPR, together
with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions
on the ability to process personal data, including health data from clinical trials and adverse event reporting. In particular, these
obligations and restrictions concern potentially burdensome documentation requirements, granting certain rights to individuals to control
how we collect, use, disclose, retain and process information about them, the information provided to the individuals, the transfer of
personal data out of the EU, security breach notifications, and security and confidentiality of the personal data. The processing of sensitive
personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest
among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to &euro;20&nbsp;million
or 4% of the annual global revenue of the noncompliant company, whichever is greater. Data protection authorities from the different EU
member states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of
processing personal data in the EU.&nbsp;Guidance on implementation and compliance practices are often updated or otherwise revised.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>European Union Coverage Reimbursement and Pricing</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the European Union, pricing and reimbursement
schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug
candidate to currently available therapies, or so called health technology assessments, in order to obtain reimbursement or pricing approval.
For example, the European Union provides options for its member states to restrict the range of drug products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states
may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the
company.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to market any product outside of the
United&nbsp;States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable
foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions
such as in China and Japan. Although many of the issues discussed above with respect to the United&nbsp;States apply similarly in the
context of the EU, the approval process varies between countries and jurisdictions and can involve additional product testing and additional
administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer
than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another,
but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in
others. Failure to comply with applicable foreign regulatory requirements, may be subject to, among other things, fines, suspension or
withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Non-clinical studies and clinical trials</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similarly to the United&nbsp;States, the various
phases of non-clinical and clinical research in the EU are subject to significant regulatory controls.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Non-clinical studies are performed to demonstrate
the health or environmental safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with
the principles of good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC.&nbsp;In particular, non-clinical studies, both
in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which
define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These
GLP standards reflect the Organization for Economic Co-operation and Development requirements.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials of medicinal products in the EU
must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on
good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the
Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical
trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint
an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU
member states, the sponsor is liable to provide &lsquo;no fault&rsquo; compensation to any study subject injured in the clinical trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Certain countries outside of the United&nbsp;States,
including the EU, have a similar process that requires the submission of a clinical study application (CTA) much like the IND prior to
the commencement of human clinical studies. A CTA must be submitted to each country&rsquo;s national health authority and an independent
ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved by the national health authority and the ethics
committee has granted a positive opinion in relation to the conduct of the trial in the relevant member state(s), in accordance with a
country&rsquo;s requirements, clinical study development may proceed.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CTA must include, among other things, a copy
of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
medicinal product under investigation. Currently, CTAs must be submitted to the competent authority in each EU member state in which the
trial will be conducted. Under the new Regulation on Clinical Trials, which is currently expected to become applicable by early 2022,
there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other
national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with
the CTA must be notified to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials
must be manufactured in accordance with good manufacturing practice (GMP). Other national and EU-wide regulatory requirements also apply.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To market a medicinal product in the EU and in
many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates
can only be commercialized after obtaining a Marketing Authorization (MA). To obtain regulatory approval of an investigational medicinal
product under EU regulatory systems, we must submit a marketing authorization application (MAA.) The process for doing this depends, among
other things, on the nature of the medicinal product. There are two types of Mas:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 24px"></TD><TD STYLE="width: 24px; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the &ldquo;Union MA&rdquo;, which is issued by the European
Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) and which is valid throughout the entire territory of the EU.&nbsp;The Centralized Procedure is mandatory
for certain types of products, such as (i)&nbsp;medicinal products derived from biotechnology medicinal products, (ii)&nbsp;designated
orphan medicinal products, (iii)&nbsp;advanced therapy products (such as gene therapy, somatic cell therapy or tissue-engineered medicines),
and (iv)&nbsp;medicinal products containing a new active substance indicated for the treatment certain diseases, such as HIV/AIDS, cancer,
neurodegenerative diseases, diabetes, other auto-immune and viral diseases. The Centralized Procedure is optional for products containing
a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical
innovation or that the granting of authorization would be in the interest of public health in the EU; and</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD></TD><TD STYLE="text-align: left">&#9679;</TD><TD STYLE="text-align: justify">&ldquo;National Mas&rdquo;, which are issued by the competent
authorities of the EU member states and only cover their respective territory, are available for products not falling within the mandatory
scope of the Centralized Procedure. Where a product has already been authorized for marketing in an EU member state, this National MA
can be recognized in another member state through the Mutual Recognition Procedure. If the product has not received a National MA in
any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure.
Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which
the MA is sought, one of which is selected by the applicant as the Reference member state.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the above-described procedures, in order
to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product
on the basis of scientific criteria concerning its quality, safety and efficacy.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Centralized Procedure, the maximum timeframe
for the evaluation of a MAA by the EMA is 210&nbsp;days. Where there is a major public health interest and an unmet medical need for a
product, the CHMP may perform an accelerated review of a MA in no more than 150&nbsp;days (not including clock stops). Innovative products
that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development
and review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the US PRIME
is a voluntary scheme aimed at enhancing the EMA&rsquo;s support for the development of medicines that target unmet medical needs. It
is based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development
plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from PRIME designation can expect
to be eligible for accelerated assessment but this is not guaranteed. The benefits of a PRIME designation include the appointment of a
CHMP rapporteur before submission of a MAA, early dialogue and scientific advice at key development milestones, and the potential to qualify
products for accelerated review earlier in the application process.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Mas have an initial duration of five&nbsp;years.
After these five&nbsp;years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit
balance, unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Data and marketing exclusivity</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The EU also provides opportunities for market
exclusivity. Upon receiving MA, new chemical entity, or reference product candidates, generally receive eight&nbsp;years of data exclusivity
and an additional two&nbsp;years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants
from relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic
or biosimilar MA in the EU during a period of eight&nbsp;years from the date on which the reference product was first authorized in the
EU.&nbsp;The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU
until 10&nbsp;years have elapsed from the initial authorization of the reference product in the EU.&nbsp;The overall 10-year market exclusivity
period can be extended to a maximum of eleven&nbsp;years if, during the first eight&nbsp;years of those 10&nbsp;years, the MA holder obtains
an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are
held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will
be considered by the EU&rsquo;s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the EU, MAAs for new medicinal products candidates
have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (PIP) agreed
with the EMA&rsquo;s Pediatric Committee (PDCO). The PIP sets out the timing and measures proposed to generate data to support a pediatric
indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures
of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to
provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely
to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations,
or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA
is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible
for six&nbsp;months&rsquo; supplementary protection certificate extension (if any is in effect at the time of authorization).</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Post-Approval Requirements</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similar to the United&nbsp;States, both MA holders
and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the
competent regulatory authorities of the member states. The holder of a MA must establish and maintain a pharmacovigilance system and appoint
an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">All new MAA must include a risk management plan
(RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks
associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA.&nbsp;Such risk-minimization
measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct
of additional clinical trials or post-authorization safety studies.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The advertising and promotion of medicinal products
is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
is also prohibited in the EU.&nbsp;Although general requirements for advertising and promotion of medicinal products are established under
EU directives, the details are governed by regulations in each member state and can differ from one country to another.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The aforementioned EU rules are generally applicable
in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For other countries outside of the EU, such as
countries in Latin America or Asia (e.g. China and Japan), the requirements governing the conduct of clinical studies, product licensing,
pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP
and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail
to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of
regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Privacy and data protection laws</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are also subject to laws and regulations in
non-US countries covering data privacy and the protection of health-related and other personal information. For instance, EU member states
and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. Laws and regulations
in these jurisdictions apply broadly to the collection, use, storage, disclosure, processing and security of personal information that
identifies or may be used to identify an individual, such as names, contact information, and sensitive personal data such as health data.
These laws and regulations are subject to frequent revisions and differing interpretations,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of May&nbsp;2018, the General Data Protection
Regulation (GDPR) replaced the Data Protection Directive with respect to the processing of personal data in the European Union. The GDPR
imposes many requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent
from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime,
shortened timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining
to health data and pseudonymised (i.e., key-coded) data and additional obligations when we contract third-party processors in connection
with the processing of the personal data. The GDPR allows EU member states to make additional laws and regulations further limiting the
processing of genetic, biometric or health data. Failure to comply with the requirements of GDPR and the applicable national data protection
laws of the EU member states may result in fines of up to &euro;20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
financial year, whichever is higher, and other administrative penalties.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Japanese drug regulation</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Non-clinical studies and clinical trials</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Being a member of the International Conference
on Harmonization (ICH), Japan has pharmaceutical regulations fundamentally similar to those of the United&nbsp;States or EU.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Non-clinical studies are performed to demonstrate
the health safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with the principles of
Japanese good laboratory practice (GLP) which reflect the Organization for Economic Co-operation and Development requirements. Currently,
Japan and EU have a mutual recognition agreement for GLP, and data generated compliant with EU requirements will be accepted by the Japanese
authorities. There is no similar agreement with the United&nbsp;States.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials of medicinal products in Japan
must be conducted in accordance with Japanese regulations based on ICH guidelines governing good clinical practices (GCP). They focus
on ethics of the clinical trial and protection of the privacy of the trial subjects. If the sponsor of the clinical trial is not established
within Japan, it must appoint an entity within the country to act as its caretaker who should be authorized to act on the sponsor&rsquo;s
behalf. The sponsor must take out a clinical trial insurance policy, and, according to the industry agreement, should put in place a common
compensation policy for the injuries from the trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to the commencement of human clinical studies,
the sponsor must complete evaluation of the safety of the investigative product, and submit a clinical trial notification and the protocol
to the authorities in advance, upon agreement of the IRB of the participating institutions. When the authorities do not comment on the
notification, the sponsor may proceed with the clinical trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any substantial changes to the trial protocol
or other information submitted must be cleared by the IRB and notified to the authorities. Medicines used in clinical trials must be manufactured
in accordance with good manufacturing practice (GMP).</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To market a medicinal product in Japan, we must
obtain regulatory approval. To obtain regulatory approval of an investigational medicinal product, we must submit a new drug application.
The process for doing this depends, among other things, on the nature of the medicinal product and there are currently a few different
pathways for approval. If the product is designed for treating certain &ldquo;difficult diseases&rdquo; or those whose patient size is
limited, we may be able to obtain designation as an orphan drug product if it demonstrates unique therapeutic value. Approval application
for such designated orphan products will be processed on an expedited basis and the authorities&rsquo; requirement for clinical data will
be much limited. Separately, the latest amendment to the law introduced separate pathways for (i)&nbsp;truly innovative products with
a unique mode of action and (ii)&nbsp;those which will satisfy unmet medical needs. These products will also be processed on an expedited
basis.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The evaluation of applications will be based on
an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
Once the review organization complete its review task, the matter will be considered by the advisory committee of experts, and the government
will grant approval upon positive recommendation from the committee.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The volume and quality of the clinical data will
be the key determinant of the approval decision. Clinical trial data generated overseas will be accepted as part of the data package consistent
with the ICH recommendation. Typically, a limited dose response clinical trial for Japanese subjects is required to ensure that data are
extrapolatable for the Japanese population. In a more recent development, the authorities encourage manufacturers to organize an international
joint clinical trial with some Japanese participation under a joint protocol, to expedite the clinical trial process. Regulatory approval
does not expire.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Separate from the approval requirement, it is
also mandatory to possess a distribution license of an appropriate class for the manufacturer to commercially distribute the product in
Japan. Non-Japanese companies who possess only the product approval may designate an appropriate license holder in Japan to commercially
distribute the product, rather than distributing it on its own. The license is valid for 5&nbsp;years.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Exclusive License Agreement with Children&rsquo;s Hospital Medical
Center, d/b/a Cincinnati Children&rsquo;s Hospital Medical Center</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On June&nbsp;1, 2021 (the &ldquo;Effective Date&rdquo;),
the Company entered into a license agreement with Children&rsquo;s Hospital Medical Center, d/b/a Cincinnati Children&rsquo;s Hospital
Medical Center (&ldquo;CHMC&rdquo;) to develop and commercialize certain CHMC patents and related technology directed at a virus-like
particle (VLP) vaccine platform that utilizes nanoparticle delivery technology, which may have potential broad application to develop
vaccines for multiple infectious diseases (&ldquo;the CHMC Agreement&rdquo;). The license is exclusive, worldwide, and is for all uses
(other than the &ldquo;Excluded Field&rdquo; of immunization against, and prevention, control, or reduction in severity of gastroenteritis
caused by Rotavirus and Norovirus in China and Hong&nbsp;Kong). The license is sublicensable with prior CHMC written approval consistent
with the terms of the CHMC Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement includes the below patents,
which we refer to as the &ldquo;Licensed Patents&rdquo;, and any divisionals, continuations and continuations-in-part thereto (solely
to the extent that the claims in the continuations-in-part are directed to the subject matter specifically claimed in the Licensed Patents,
and they have the same priority date as the Licensed Patents, but do not include any different or additional claims), and any patents
resulting therefrom:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; width: 18%"><B>U.S.&nbsp;Patent<BR>
Application No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center"><B>U.S.<BR>
Patent<BR>
 No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; width: 21%; text-align: center"><B>Granted Claim Type</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center"><B>U.S.<BR>
Expiration</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; width: 37%; text-align: center"><B>Foreign Counterparts</B></TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>12/797,396</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">8,486,421</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Compositions of the vaccine/vaccine platform</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">1/13/2031</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>CN107043408B EP2440582B1 JP5894528B2</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>13/924,906</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">9,096,644</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Method of treatment</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">9/20/2030</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>CN107043408B EP2440582B1 JP5894528B2</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>13/803,057</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">9,562,077</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Compositions of the vaccine platform</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">11/8/2033</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>none</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>16/489,095</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>pending**</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">[3/15/2038]*</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Pending applications in Canada, China, EU and Japan</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>63/149,742 (filed 2/16/2021)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>pending**</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">[February&nbsp;2042]<SUP>#</SUP></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>TBD</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>63/162,369 (filed 3/17/2021)</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">[March&nbsp;2042]<SUP>#</SUP></TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>TBD</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 24px; text-align: left">*</TD><TD STYLE="text-align: justify">Projected expiration if patent issues: 20&nbsp;years from
earliest non-provisional application filing date.</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">#</TD><TD STYLE="text-align: left">Non-provisional application not yet filed. Expiration projected
21&nbsp;years from provisional application filing date. Dependent on timely conversion to non-provisional application and issuance of
patent.</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: justify">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">**</TD><TD STYLE="text-align: left">This is a pending application. Claim type will be determined
after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions of the vaccine and vaccine platform.</TD>
</TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement also grants the Company a non-exclusive
limited license to use and copy internally any technical information in existence and known before the Effective Date by CHMC solely as
necessary for the use and practice of the Licensed Patents (the &ldquo;Technology&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The term of the CHMC Agreement begins on the Effective
Date and extends on a jurisdiction by jurisdiction and product by product basis until the later of: (i)&nbsp;the last to expire Licensed
Patent; (ii)&nbsp;ten (10)&nbsp;years after the first commercial sale; or, (iii)&nbsp;entrance onto the market of a biosimilar or interchangeable
product. CHMC has reserved the right to practice, have practiced, and transfer the Licensed Patents and Technology for research and development
purposes, including education, research, teaching, publication and public service, but not to use or practice the Licensed Patents or
Technology in Field of Use for any commercial or profit purpose.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Licensed Patents granted to the Company under
the CHMC Agreement are also subject to any rights of the United&nbsp;States federal, state and/or local Government(s), as well as nonprofit
entities, if certain patents or technologies were created in the course of Government-funded or non-profit entity-funded research. The
CHMC Agreement also contains compulsory licensing provisions under which CHMC must notify the Company in writing whenever CHMC may become
aware of third parties that are interested in obtaining rights to the Licensed Patents or Technology for purposes that are beyond the
scope of the Company&rsquo;s development and commercialization plan. The Company may elect to pursue the new purposes itself (and negotiate
commercially reasonable development targets), or enter into sublicense negotiations with the interested third party. However, if the Company
fails to meet its development targets for the new purposes or fails to enter into a sublicense agreement with the interested third party
within nine (9)&nbsp;months of the notice from CHMC, then the new purpose will be excluded from the license grant and CHMC will be free
to pursue licensing of the Licensed Patents or Technology within the Excluded Field to an interested third party.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any patented modification, alteration or improvement
of any invention claimed in a Licensed Patents or Technology which is conceived or reduced to practice solely by the Company (&ldquo;Company
Improvement&rdquo;) is owned by the Company; however, for any such Company Improvement, the Company will automatically grant to CHMC a
worldwide, perpetual, sublicensable, nonexclusive, paid-up, royalty-free license to use any Company Improvements solely for clinical or
non-clinical, non-commercial research, testing, educational and patient care purposes. The CHMC Agreement also provides the Company with
an option to license any CHMC or jointly patented modification, alteration or improvement of any invention claimed in a Licensed Patent
(&ldquo;CHMC Improvement&rdquo; and &ldquo;Joint Improvement, respectively&rdquo;), with option fee for each Improvement that the Company
elects to include in the license grant of the CHMC Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay CHMC an aggregate
of up to $59.75&nbsp;million upon the achievement of specified development milestones, of approximately $0.5&nbsp;million, regulatory
milestones, of approximately $1.25&nbsp;million and commercial milestones, of approximately $58&nbsp;million (excluding any royalty arrangements).
In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the Company is obligated
to pay CHMC a percentage of all non-royalty sublicensing revenue. Specifically, the Company must pay twenty-five percent (25%) for revenue
received from the sublicensee prior to first net sale of a licensed product, fifteen percent (15%) for revenue received after first net
sale of a licensed product or five percent after the first sale of a second licensed product. No annual maintenance fee is required.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to the CHMC Agreement, the Company paid
to CHMC a one-time $25,000 initial license fee; thereafter, the Company is required to pay $100,000 deferred license fee upon the earlier
of the Company&rsquo;s first to occur convertible debt or equity raise after the Effective Date. On the one year anniversary of the Effective
Date, the Company will be required to pay to CHMC an additional deferred $100,000 license fee.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the CHMC Agreement, the Company is obligated
to use commercially reasonable efforts to bring licensed products to market through diligent research and development, testing, manufacturing
and commercialization and to use best efforts to make all necessary regulatory filings and obtain all necessary regulatory approvals,
and achieve milestones relating to development and sales, and report to CHMC on progress. The Company will also be obligated to pay the
agreed upon development milestone payments to CHMC.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Development milestones include: (i)&nbsp;IND filings
of each Licensed Product; (ii)&nbsp;BLA or equivalent allowed for Licensed Product in U.S.&nbsp;or E.U.; (iii)&nbsp;first commercial sale
of licensed product in the U.S.; (iv)&nbsp;first commercial sale of licensed product in the E.U.; (v)&nbsp;first commercial sale of licensed
product in Japan; (vi)&nbsp;first commercial sale in Rest of World (ROW); (vii)&nbsp;conclusion of the first calendar year. Pursuant to
the terms of the CHMC Agreement, if the Company fails to achieve milestones or make milestone payments on certain milestones, and cannot
mutually agree with CHMC on an amendment to the milestones, then CHMC will have the option of converting any and all of such exclusive
licenses to nonexclusive licenses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the fees discussed above, beginning
on the first Net Sale, the Company will pay CHMC running royalties on a quarterly basis as a percentage of Net Sales (as defined in the
CHMC Agreement) of the Company, its affiliates and any subsidiaries. Similarly, in the event the Company enters into a sublicense agreement,
the Company shall pay CHMC a percentage of all non-royalty sublicensing revenues received from the sublicensee. There is a 5% royalty
rate for products and processes for P-Particle VLP Bivalent vaccine for norovirus and rotavirus; a 4% royalty rate for products and processes
for Universal Flu Vaccine(s); and a 2% royalty rate for all other products or processes for other indications. To date, no payments have
been made related to the milestones or royalties. Before any Valid Claims (as defined in the CHMC Agreement) exist, the running royalty
rates are reduced by fifty percent (50%).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement also contains an anti-stacking
provision pursuant to which in the event the Company is legally required to pay royalties to one or more third parties whose patent rights
dominate the Licensed Patents, and would therefore be infringed by exercise of the license rights granted in the CHMC Agreement, the Company
may reduce running royalty payments by fifty percent (50%). In the event the Company grants sublicenses, the Company is obligated to pay
CHMC as follows: (i)&nbsp;specified percentage of revenue received prior to first Net Sale of first Licensed Product; (ii)&nbsp;specified
percentage for revenue received after first Net Sales of first Licensed Product but before first Net Sales of second Licensed Product;
or (iii)&nbsp;specified percentage for revenues received after first Net Sales of second Licensed Product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC reserved the first and sole right, using
in-house or outside legal counsel selected by CHMC, to prepare, file, prosecute, maintain and extend patents and patent applications,
and the Company agreed to reimburse CHMC for its legal and administrative costs incurred in the course of doing such. The Company also
agreed to reimburse CHMC for incurred legal fees of approximately $177,100 as of the Effective Date. CHMC will provide the Company a reasonable
opportunity to comment during prosecution and will consider the Company&rsquo;s comments, but CHMC retained control over all final decisions.
If CHMC elects to not be responsible for the prosecution or maintenance of any such patents, the Company will receive a sixty (60)&nbsp;days&rsquo;
written notice upon which the Company may elect, at the Company&rsquo;s expense, to assume the responsibilities and obligations to prosecute
and maintain the patents (among other things); thereafter, the Company will use reasonable efforts to give CHMC an opportunity to comment,
but the final decision with respect to such matter will remain with the Company.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement contains no CHMC representations
or warranties. The CHMC Agreement also requires the Company to indemnify CHMC and other related parties against all claims, suit, actions,
demands, judgments, or investigations arising out of any product the Company produces under the CHMC Agreement, as set forth in the CHMC
Agreement, and requires the Company, beginning with the earlier of the first clinical trial or commercial sale or other commercialization
to obtain liability insurance.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC will have the first and sole right but not
the obligation, at its own expense, to initiate an infringement suit or other appropriate actions against third party infringers and receives
all therefrom. For joint suits initiated against third party infringers and receives damages or profits recovered therefrom. In the event
CHMC does not, within six (6)&nbsp;months after becoming aware of infringement, secure cessation of the infringement, the Company will
have the right to initiate suit at its own expense. Any damages or profits that the Company recovers will be treated as Net Sales subject
to royalties after the Company has been compensated for its costs in handling such action. In the event of a joint infringement suit,
the Company and CHMC will agree in writing who will control the action and how cost and recoveries will be shared.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company may terminate the CHMC Agreement for
convenience, at any time prior to first commercial sale of a product or process by providing one hundred and eighty (180)&nbsp;days&rsquo;
written notice to CHMC.&nbsp;It may also terminate for a CHMC uncured material breach. CHMC may terminate the CHMC Agreement for an uncured
Company material breach or insolvency or bankruptcy. In the event the Company&rsquo;s material breach is for failure to meet any of the
milestone payments, the Company is entitled to a nonexclusive license to continue developing indications that have already entered development
at any stage or in which the Company has invested in developing. CHMC may also terminate the CHMC Agreement to the fullest extent permitted
by law in the countries of the worldwide territory, in the event the Company or its affiliates challenge or induce others set up challenges
to the validity or enforceability of any of the Licensed Patents and the Company will be obligated reimburse CHMC for its costs, including
reasonable attorneys&rsquo; fees.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">In addition to the CHMC Agreement, the Company also
entered into a sponsored research agreement dated June&nbsp;30, 2022 with CHMC for research related to the CHMC Agreement (the &ldquo;CHMC
SRA&rdquo;). Pursuant to this research agreement, the Company is obligated to pay CHMC an aggregate amount not-to-exceed $247,705.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Option Agreement between Oxford University Innovation Limited
and Blue Water Vaccines Inc.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On December&nbsp;18, 2018, the Company entered
into an option agreement with Oxford University Innovation Limited (&ldquo;OUI&rdquo;), pursuant to which the Company paid an option fee
of between $25,000, to OUI in exchange for a period of exclusivity, in advance of a fundraising of fifteen million dollars ($15,000,000).
Under the option agreement, the Company has the right to exercise the option for the grant of the right to the Company to an exclusive,
worldwide license to PCT Patent Application number PCT/GB/2017/052510, any patents granted in response to that application, any corresponding
foreign patents and applications deriving priority from that application, and any addition, continuation, continuation-in-part, division,
reissue, renewal or extension based thereon, and related know-how and confidential information (the &ldquo;Technology&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Exercise of the option by the Company was conditional
upon the Company submitting a business plan for the subsequent two&nbsp;years, including a development plan for the technology and a financial
projection, demonstrating the Company&rsquo;s ability to develop the Technology and evidence of the Company&rsquo;s solvency and receipt
of fifteen million dollars ($15,000,000) in funds for the development of the Technology. The Company has agreed that, as a condition precedent
to the license becoming effective, it must provide funding for three&nbsp;years of salary for Dr.&nbsp;Craig Thompson in Oxford&rsquo;s
Department of Zoology of four hundred and twenty thousand pounds (&pound;420,000). No additional funds are required to fulfill the three-year
salary commitment, at this time, and none are anticipated prior to the completion of the three year term.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>License Agreement between Oxford University Innovation Limited
and Blue Water Vaccines Inc.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On July&nbsp;16, 2019, the Company entered into
an exclusive, worldwide agreement (&ldquo;OUI Agreement&rdquo;) with Oxford University Innovation Limited (&ldquo;OUI&rdquo;), pursuant
to which the Company obtained an exclusive worldwide license for all fields to PCT Patent Application number PCT/GB/2017/052510, entitled
&ldquo;Immunogenic Composition,&rdquo; any patents granted in response to that application, any corresponding foreign patents and applications
deriving priority from that application, and any addition, continuation, continuation-in-part, division, reissue, renewal or extension
based thereon, and a nonexclusive license to related know-how and confidential information, as set forth in the below chart (the &ldquo;Licensed
Technology&rdquo;):</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt"><B>U.S.&nbsp;Patent<BR>
Application&nbsp;No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; text-align: center"><B>U.S.&nbsp;Patent No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 20%; border-bottom: black 1.5pt solid; text-align: center"><B>Granted Claim Type</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt; text-align: center"><B>U.S.&nbsp;Expiration</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 31%; border-bottom: black 1.5pt solid; text-align: center"><B>Foreign Counterparts</B></TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>16/326,749</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">11,123,422</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Compositions and method of treatment</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">8/25/2037</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>Pending applications in Australia, Canada, China, EU and Japan</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD>17/458,712</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>pending</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD STYLE="text-align: center">[8/25/2037]*</TD>
    <TD STYLE="white-space: nowrap">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">*</TD>
    <TD>Projected expiration if patent issues: 20&nbsp;years from earliest non-provisional application filing date.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">**</TD>
    <TD>This is a pending application. Claim type will be determined after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions of the compositions and method of treatment.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The OUI Agreement has a term concluding ten&nbsp;years
following the last to expire of all licensed patents and patent applications as defined under the terms of the OUI Agreement. The license
was conditional upon the Company entering into a separate agreement with Oxford University to provide funding for three&nbsp;years&rsquo;
salary for Dr.&nbsp;Craig Thompson in the University&rsquo;s Department of Zoology, which amounted to four hundred and twenty thousand
pounds (&pound;420,000), which was paid by the Company in January&nbsp;2020. No additional funds are required to fulfill the three-year
salary commitment, at this time, and none are anticipated prior to the completion of the three year term.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Improvements to the Licensed Technology as defined
in the OUI Agreement belong to OUI and are included in the Licensed Technology. All Company Improvements of belong to the Company. The
Company granted to OUI, and OUI subsequently granted to Oxford University, a non-transferable, irrevocable, perpetual, royalty-free license
to use and publish the Licensed Technology and the Company&rsquo;s Improvements upon the Licensed Technology for non-commercial use. If
a Licensed Product is covered by the Medicines Access Policy of Oxford University to promote, the Company shall adhere to the requirements
of the Medicines Access Policy.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay OUI milestone payments
of up to an aggregate of $51&nbsp;million upon the achievement of specified development milestones, of approximately $2.25&nbsp;million,
regulatory milestones, of approximately $9.5&nbsp;million and commercial milestones, of approximately $39.5&nbsp;million (excluding any
royalty arrangements). An annual maintenance fee, or minimum sum, $10,000 to $20,000 will be required beginning in 2023 through launch,
increasing to $250,000, which would be the highest &ldquo;minimum sum&rdquo; of royalties in any year prior until expiration or revocation
of the last valid claim covering a licensed product, in which case the annual maintenance fee will no longer be required and the &ldquo;step
down&rdquo; royalty rate will apply.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company did not pay a signing fee to OUI and
is obligated to pay a 6% royalty on all net sales of licensed products, as defined in the OUI Agreement, as well as royalties between
25% on any sums received by the Company from any sublicensee (including all up-front, milestone and other one-off payments received by
the Company from any sub-licenses or other contracts granted by the Company with respect to the licensed technology). After the expiration
or revocation of the last Valid Claim (as defined in the OUI Agreement) covering a Licensed Product, a &ldquo;step down&rdquo; royalty
rate shall apply to such Licensed Technology and no minimum sum will be payable by the Company. If the Company has to pay royalties to
a third party to use a proprietary manufacturing process proprietary adjuvants in order to make or have made a Licensed Product, the Company
will be able to deduct from all royalty payments, up to a maximum amount of twenty-five percent (25%) of the royalties due to OUI.&nbsp;The
OUI Agreement entitles the Company to supply a commercially reasonable quantity (not exceeding 5% of units sold in any quarter) of licensed
products for promotional sampling.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the event that royalties paid to OUI do not
amount to the &ldquo;minimum sum&rdquo;, as discussed above, under the OUI Agreement for a particular year, the Company is obligated to
make up the difference between the royalties actually paid and such minimum sum. The minimum sums vary over time, and reduces to $0 once
the &ldquo;step down&rdquo; applies. The minimum sums and milestone fees are indexed to the RPI (Retail Prices index for all items which
is published in the United Kingdom by the Office for National Statistics, or any replacement of it) and will be increased or decreased
as appropriate as set forth in the OUI Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is obligated to use its best efforts
to develop and market Licensed Products in accordance with its development plan report to OUI on progress and achieve the following milestones
and must pay OUI nonrefundable milestone fees as follows when it achieves them: initiation of first Phase&nbsp;I study; initiation of
first Phase&nbsp;II study; initiation of first Phase&nbsp;III/pivotal registration studies; first submission of application for regulatory
approval (BLA/NDA); marketing authorization in the United&nbsp;States; marketing authorization in any EU country; marketing authorization
in Japan; first marketing authorization in any other country; first commercial sale in Japan; first commercial sale in any ROW country;
first year that annual sales equal or exceed certain thresholds.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is obligated to pay, and has paid,
&pound;11,323 to OUI for any past patent expenses that were incurred prior to the execution of the OUI Agreement. Upon consultation with
the Company and at the Company&rsquo;s expense, OUI shall prosecute, use all reasonable endeavors to maintain and renew the patents throughout
the duration of the OUI Agreement. The Company and OUI agreed to inform each other in writing of any misappropriation or infringement
of any rights to the licensed technology; however, the Company has the first right to take legal action at its own cost in relation to
any such misappropriation or infringement, but must discuss any proposed legal action with OUI and take into account any legitimate interest
of OUI in the legal action that it takes. If the Company notifies OUI that it does not intend to take legal action in such matters, OUI
may take any legal action at its own cost. All profits or damages recovered after unrecovered costs and expenses are deducted are treated
as net sales for which royalties would be due.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">OUI makes no warranties at all with regard to
the Licensed Technology or whether use of it will infringe third party rights. The Company is required to indemnify OUI and Oxford University
from all third party claims, damages, and liabilities asserted by third parties arising directly or indirectly from use of the Licensed
Technology; marketing of Licensed Products; or breach of the OUI Agreement. The OUI Agreement is governed by English law and the parties
agreed to submit to the exclusive jurisdiction of English Courts for resolution of any disputes arising out of or in connection with the
OUI Agreement, with the exception of actions relating to intellectual property disputes or confidential information which may be brought
in any court of competent jurisdiction.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Either party may terminate the OUI Agreement for
an uncured material breach. The Company may terminate the OUI Agreement for any reason at any time upon six&nbsp;months&rsquo; written
notice expiring after the third anniversary of the OUI Agreement. OUI may terminate immediately if the Company has a petition presented
for its winding-up or passes a resolution for winding up other than for a bona fide amalgamation or reconstruction or compounds with its
creditors or has a receiver or administrator appointed. OUI may also terminate if the Company opposes or challenges the validity of any
of the patents or applications in the Licensed Technology; raises the claim that the know-how of the Licensed Technology is not necessary
to develop and market Licensed Products; or in OUI&rsquo;s reasonable opinion, is taking inadequate or insufficient steps develop or market
Licensed Products and does not take any further steps that OUI requests by written notice within a reasonable time.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white">Pursuant
to the terms of the OUI Agreement, the Company entered into a sponsored research agreement (the &ldquo;OUI SRA&rdquo;), dated December&nbsp;18,
2019 with Oxford University for research related to the OUI Agreement for a period of&nbsp;three&nbsp;years for a total of &pound;420,000.
The Company prepaid the full amount to Oxford of $554,802&nbsp;for the services in January&nbsp;2020.</FONT> Pursuant to an amendment
to the SRA (the &ldquo;OUI SRA Amendment&rdquo;), dated May 16, 2022, the term of the research under the SRA was extended for an additional
18 months, culminating on June 18, 2024. The OUI SRA Amendment also requires that the Company provide additional funding in connection
with the research in the amount of &pound;53,500.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Exclusive License Agreement between St. Jude Children&rsquo;s
Research Hospital, Inc.&nbsp;&amp; Blue Water Vaccines Inc.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On January&nbsp;27, 2020 (the &ldquo;Effective
Date&rdquo;), the Company entered into an exclusive, worldwide license agreement with St. Jude Children&rsquo;s Research Hospital, Inc.
(&ldquo;St. Jude&rdquo;), pursuant to which St. Jude granted the Company an exclusive license to develop licensed products and produce
vaccines for use in humans (&ldquo;St. Jude Agreement&rdquo;) under U.S.&nbsp;Provisional Patent Application No. 61/537,290 (U.S.&nbsp;Patent
No. 9,265,819 issued on February&nbsp;23, 2016), and U.S.&nbsp;Provisional Patent Application No. 62/817,748 (filed March&nbsp;13, 2019),
and any issued patents, divisions, continuations, continuations-in-part, to the extent that the claims are directed to subject matter
described in the above-referenced patent applications and are entitled to the priority date of the existing patent rights, re-examinations,
substitutions, renewals, restorations, additions, or registrations thereof, as well as non-United&nbsp;States counterparts thereof, and
extensions and supplementary protection certificates thereon (&ldquo;Patent Rights&rdquo;), all as set forth in the below chart:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-right: 3pt; padding-bottom: 1.5pt"><B>U.S.&nbsp;Patent<BR>
Application&nbsp;No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; text-align: center"><B>U.S.&nbsp;Patent No.</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 20%; border-bottom: black 1.5pt solid; text-align: center"><B>Granted Claim Type</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt; text-align: center"><B>U.S.&nbsp;Expiration</B></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="width: 31%; border-bottom: black 1.5pt solid; text-align: center"><B>Foreign Counterparts</B></TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD STYLE="padding-left: 10pt; text-indent: -10pt">14/345,988</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">9,265,819</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>Compositions and method of treatment</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">9/19/2032</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>none</TD></TR>
  <TR STYLE="vertical-align: top; background-color: white">
    <TD STYLE="padding-left: 10pt; text-indent: -10pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: #CCEEFF">
    <TD STYLE="padding-left: 10pt; text-indent: -10pt">17/602,414<SUP>#</SUP></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">pending</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>pending</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD STYLE="text-align: center">[3/12/2040]*</TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
    <TD>Pending Applications in: <BR>
Australia,<BR>
Brazil, Canada, China, Europe,<BR>
Hong&nbsp;Kong, Japan and Korea</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">*</TD>
    <TD STYLE="text-align: justify">Projected expiration if patent issues: 20&nbsp;years from earliest non-provisional application filing date.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">#</TD>
    <TD STYLE="text-align: justify">U.S.&nbsp;National stage entry of WO 2020/183420 (PCT/IB2020/052250).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">**</TD>
    <TD>This is a pending application. Claim type will be determined after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions and method of treatment.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The license is sublicensable consistent with the
terms and conditions of the St. Jude Agreement, provided that the Company remains responsible for the performance by each of its sublicensees.
The license is subject to any government rights the United&nbsp;States has reserved, and St. Jude retained the right to make, have made,
provide and use for St. Jude&rsquo;s non-commercial research and clinical purposes, including the right to distribute St. Jude&rsquo;s
biological material disclosed and claimed in the Patent Rights for non-profit academic research use to non-commercial entities as is customary
in the scientific community and to sell the biological materials as research reagents for research use only by the scientific community.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt"></P></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay St. Jude milestone
payments of up to an aggregate of $1.0&nbsp;million upon the achievement of specified development milestones, of approximately $0.2&nbsp;million,
regulatory milestones, of approximately $0.3&nbsp;million and commercial milestones, of approximately $0.5&nbsp;million (excluding any
royalty arrangements). In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the
Company is obligated to pay St. Jude fifteen percent of any sublicense consideration, subject to specified exclusions, but including any
upfront or milestone fees and including any premium paid by sublicensee over Fair Market Value (as defined in the agreement) for the Company&rsquo;s
stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In exchange for the licenses, the Company paid
St. Jude an initial license fee of $15,000 and is required to pay an annual maintenance fee of $10,000 beginning on the first anniversary
of the Effective Date (which is waived if all of the developmental milestones scheduled for completion before such annual fee is due have
been achieved), milestone payments, patent reimbursement, and running royalties based on net sales of licensed products under the St.
Jude Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the St. Jude Agreement, the Company is obligated
to use commercially reasonable efforts to develop and commercialize the licensed product(s). If the Company fails to achieve the development
milestones contained in the St. Jude Agreement, and if the Company and St. Jude fail to agree upon a mutually satisfactory revised time
line, St. Jude will have the right to terminate the St. Jude Agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The milestones include the following events: (i)&nbsp;complete
IND enabling study by 2020; (ii)&nbsp;Initiate animal toxicology study by last half of 2020; (iii)&nbsp;file IND by first half of 2021;
(iv)&nbsp;complete Phase&nbsp;I Clinical Trial by first half of 2022; (v)&nbsp;commence Phase&nbsp;II Clinical Trial by first half of
2024; (vi)&nbsp;commence Phase&nbsp;III Clinical Trial by 2026; and, (vii)&nbsp;regulatory approval, U.S.&nbsp;or foreign equivalent by
2026. Upon achievement of certain development and commercialization milestones, the Company is required to make milestone payments to
St. Jude between the achievement of certain milestones (commencement of a Phase&nbsp;III clinical trial through first commercial sale).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the Company is obligated to make
running 4% royalty payments payable, for each licensed product(s)&nbsp;sold by the Company, its affiliates or sublicensees, based on the
net sales for the duration of the St. Jude Agreement. Furthermore, the Company is obligated to pay a percentage between 15% of other consideration
received for any sublicenses.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On May 11, 2022, the Company and St. Jude entered
into a first amendment to the St. Jude Agreement (the &ldquo;St. Jude Amendment&rdquo;). The St. Jude Amendment provides for a revised
development milestone timeline, a one-time license fee of $5,000, and an increase to the royalty rate from 4% to 5%. The St. Jude Amendment
also provides for an increase to the contingent milestone payments, from $1.0 million to $1.9 million in the aggregate; specifically,
development milestones of $0.3 million, regulatory milestones of $0.6 million, and commercial milestones of $1.0 million.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company reimbursed St. Jude approximately
$32,400 for certain patent costs incurred by St. Jude prior to the Effective Date of the St. Jude Agreement, and is obligated to reimburse
St. Jude for reasonable patent costs incurred by St. Jude subsequent to the Effective Date.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is responsible for and shall bear
all expenses relating to the filing, prosecution, and maintenance of all patent rights licensed under the St. Jude Agreement. The Company
has the first right to enforce any patent against infringement, and shall keep St. Jude informed of the status of such; however, before
the Company may commence any action with respect to any such alleged infringement, the Company shall take into consideration the views
of St. Jude and the potential effect on the public interest.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to initial human testing or first commercial
sale of a licensed product, and thereafter so long as the licensed products are being sold in any particular country, the Company (and
its sublicenses) is required to obtain and maintain insurance to cover its indemnity obligations, and to obtain and maintain product liability
insurance coverage.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">St. Jude represented and warranted that it has
good and marketable title to the Patent Rights, but made no other representations and warranties. The term of the agreement commenced
on the Effective Date, and shall continue, in each country, until the date of expiration of the last to expire valid claim included within
the Patent Rights in that country. Either party may terminate the St. Jude Agreement in the event the other party (a)&nbsp;files or has
filed against it a petition under the Bankruptcy Act (among other things) or (b)&nbsp;fails to perform or otherwise breaches its obligations
under the St. Jude Agreement, and has not cured such failure or breach within sixty (60)&nbsp;days. The Company may terminate for any
reason on thirty (30)&nbsp;days written notice.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the St. Jude Agreement, the Company
also entered into a sponsored research agreement (the &ldquo;St. Jude SRA&rdquo;) dated <FONT STYLE="font-family: Times New Roman, Times, Serif">May</FONT>&nbsp;3,
2021 with St. Jude for research related to the St. Jude Agreement. Pursuant to the St. Jude SRA, the Company is obligated to pay St. Jude
an aggregate amount of $73,073 in two parts, Phase&nbsp;I for $57,624 and Phase&nbsp;II for $15,449. This sponsored research project began
during the year ended December&nbsp;31, 2021.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 16pt 0pt 0; text-indent: 16.2pt">The Company entered into a second sponsored
research agreement with St. Jude, dated August 29, 2022, pursuant to which the Company is obligated to pay St. Jude an amount of $75,603
which is due within 30 days of the effective date of the agreement.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We currently do not own or operate any manufacturing
facilities, but our strategic partnership with Ology Bioservices, Inc. (which was later acquired by National Resilience, Inc.) (&ldquo;Ology&rdquo;)
provides us with access to substantial resources to facilitate an independent supply path to the market. Ology is a leading global contract
manufacturer with deep domain expertise and experience in large and small-scale production of clinical, as well as commercial-stage products.
We have entered into agreements with Ology to secure capacity, technical expertise and resources to support the production of our products
and processes that are intended to scale to commercial scale at Ology or other commercial manufacturing sites.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In July&nbsp;2019, we entered into a development
and manufacturing master services agreement with Ology, which we refer to, as amended, as the Ology Agreement, pursuant to which Ology
is obligated to perform manufacturing process development and clinical manufacture and supply of components.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Ology Agreement, we will pay Ology agreed
upon fees for Ology&rsquo;s performance of manufacturing services, and we will reimburse Ology for its out-of-pocket costs associated
with purchasing raw materials, plus a customary handling fee. The Company entered into an initial Project Addendum on October&nbsp;18,
2019 and the Company was required to pay Ology an aggregate of approximately $4&nbsp;million. Due to unforeseen delays associated with
COVID-19, the Company and Ology entered into a letter agreement dated January&nbsp;9, 2020 to stop work on the project. The Company paid
Ology $100,000 for services, of which $48,600 remains as prepaid expense as of December&nbsp;31, 2020. The second Project Addendum was
executed May&nbsp;21, 2021 and the Company is obligated to pay Ology an aggregate amount of approximately $2.8&nbsp;million, plus reimbursement
for materials and outsourced testing, which will be billed at cost plus 15%. This project began during the year ended December&nbsp;31,
2021, and the Company has incurred related research and development expenses of approximately $328,000 of which approximately $164,000
and $115,000 was recorded as accounts payable and accrued expenses, respectively, at December&nbsp;31, 2021.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif">On
April 20, 2022, the Company entered into an amendment to the Ology MSA, whereby the Company&rsquo;s obligations increased by $300,000,
specifically related to regulatory support on the project.</FONT> On August 30, 2022, the Company entered into another amendment to the
Ology MSA which reduced the Company&rsquo;s obligations by approximately $379,000 as a result of changes in the scope of work related
to certain tasks defined in the second Project Addendum. <FONT STYLE="font-family: Times New Roman, Times, Serif">During the three and
nine months ended September 30, 2022, the Company incurred related research and development expenses of approximately $496,000 and $988,000,
respectively, and had approximately $53,000 and $851,000 recorded as related accounts payable and accrued expenses, respectively, at September
30, 2022.</FONT></P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Either party may terminate a Project Addendum
and/or the Ology Agreement upon the material breach of any provision of this Agreement by the other Party if such breach is not cured
by the breaching party within thirty&nbsp;(30)&nbsp;calendar&nbsp;days after receipt by the breaching Party of written notice of such
default. The Company may terminate the Ology Agreement or the associated Project Addendum for any or no reason upon sixty (60)&nbsp;days&rsquo;
prior written notice to Ology.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">As of November 9, 2022, we had 5 full-time and 8
subcontracted employees. None of our employees are represented by a <FONT STYLE="font-family: Times New Roman, Times, Serif">collective</FONT>
bargaining agreement, and we have never experienced any work stoppage. We believe we have good relations with our employees.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are currently leasing an office located at
201 E Fifth Street, Suite 1900, Cincinnati, OH&nbsp;45202, which is renewed on a monthly basis. All of our research and development is
performed on the premises of our third-party providers.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">From time to time we may be involved in various
disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>&nbsp;</B></P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our business is subject to
a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial
condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock.
These risks include, but are not limited to, the following:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We are in the early stages of vaccine development and have a very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We have incurred significant net losses since inception, do not generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. Our stock is a highly speculative investment.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 24px; font-size: 10pt"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We will require significant additional capital to make the investments we need to execute our longer-term business plan. </FONT><FONT STYLE="font-size: 10pt">We estimate that, based on our existing cash as of the date of this registration statement, we will have cash on hand sufficient to fund our operations for at least the 12&nbsp;months following the date of this registration statement<FONT STYLE="font-family: Times New Roman, Times, Serif">. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations, and we may be unable to continue as a going concern in the long term. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.</FONT></FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Due to the significant resources required for the development of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates. Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine candidates that may be more profitable or for which there is a greater likelihood of success.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We depend entirely on the success of a limited number of product candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never become profitable.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>The marketing approval process of the U.S.&nbsp;Food and Drug Association, or FDA, is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future product candidates we intend to develop, our business will be substantially harmed.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>The future results of our current or future clinical trials may not support our product candidates&rsquo; claims or may result in the discovery of unexpected adverse side effects.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Even if we obtain regulatory approval of our vaccine candidates, the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in the medical community.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD STYLE="text-align: justify">We may be adversely affected by the ongoing coronavirus pandemic.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We intend to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Our Chief Executive Officer, Chief Financial Officer and other key personnel may allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We may in the future have conflicts with our current or future partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could compete against us more directly, which would harm our business, possibly materially.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD STYLE="text-align: left">We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Some of the intellectual property covered by our licenses concerns patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.</TD></TR>
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    <TD>Healthcare Reform in the United&nbsp;States has been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry. Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.</TD></TR>
  </TABLE>
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    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Obtaining regulatory approval for clinical trials of our vaccine candidates 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.</TD></TR>
  </TABLE>
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    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.</TD></TR>
  </TABLE>
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    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock.</TD></TR>
  </TABLE>
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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>We are an &ldquo;emerging growth company&rdquo; and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.</TD></TR>
  </TABLE>
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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>Our amended and restated certificate of incorporation (&ldquo;Amended and Restated Certificate of Incorporation&rdquo;) and our amended and restated bylaws (&ldquo;Amended and Restated Bylaws&rdquo;), and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.</TD></TR>
  </TABLE>
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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>A possible &ldquo;short squeeze&rdquo; due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: left; text-indent: 0.25in">We were incorporated on October
22, 2018 under the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati,
OH 45202, and our telephone number is (513) 620-4101. Our corporate website address is&nbsp;<I>www.bluewatervaccines.com</I>. We make
available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of
the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities
and Exchange Commission (the &ldquo;SEC&rdquo;). Alternatively, you may also access our reports at the SEC&rsquo;s website at www.sec.gov.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_005"></A>RISK FACTORS</B></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; text-align: justify; text-indent: 0.25in">Our business involves a high
degree of risk and uncertainty, including the following risks and uncertainties:</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>Investing in our common stock involves a high
degree of risk. You should carefully consider the following information about these risks before deciding to invest in our common stock.
The occurrence of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results
of operations and future growth prospects, as well as our ability to accomplish our strategic objectives. As&nbsp;a result, the trading
price of our common stock could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.</I></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to our Financial Position and Need for Capital</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are in the early stages of vaccine development and have a
very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success
of our business to date and to assess our future viability.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To date, we have devoted substantially all of
our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support
of our product development efforts, hiring personnel, licensing and developing our technology and vaccine candidates, organizing and staffing
our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand
such activities. As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory
approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization
or arrange for a third party to conduct these activities on our behalf. 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.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our current vaccine candidate pipeline includes
four preclinical programs. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors
in achieving our business objectives, including with respect to our vaccine candidates. We will need to transition in the future from
a company with a research and development focus to a company capable of supporting commercial activities and may not be successful in
such a transition.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have incurred significant net losses since inception, do not
generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve
profitability. Our stock is a highly speculative investment.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are a preclinical stage biotechnology vaccine
company that was incorporated in October 2018. Investment in preclinical stage companies and vaccine development is highly speculative
because it entails substantial upfront capital expenditures and significant risk that any potential vaccine candidate will not gain regulatory
approval or become commercially viable. We do not have any products approved for sale and have not generated any revenue from product
sales. As a result, we are not profitable and have incurred losses in each year since inception. Our net loss was $3.9&nbsp;million and
$10.2 million for the three and nine&nbsp;months ended September&nbsp;30, 2022, respectively. As of September&nbsp;30, 2022, we had an
accumulated deficit of $16.2 million. We also generated negative operating cash flows of $5.9 million for the nine months ended September&nbsp;30,
2022. Our net losses were $3.4 million and $1.6 million, for the years ended December 31, 2021 and 2020, respectively. As of December
31, 2021, we had an accumulated deficit of $6.0 million.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We expect to continue to spend significant resources
to fund research and development of, and seek regulatory approvals for, our vaccine candidates. We expect to incur substantial and increasing
operating losses over the next several&nbsp;years as our research, development, manufacturing, preclinical testing and clinical trial
activities increase. As a result, our accumulated deficit will also increase significantly. Additionally, there can be no assurance that
the product candidates currently under development or that may be under development by us in the future will be approved for sale in the
U.S.&nbsp;or elsewhere. Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized,
and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability,
we may be unable to continue our operations.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will require substantial additional funding to finance our
long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain
of our development programs or other operations.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of September 30, 2022, we had cash of $29.1&nbsp;million.
As of December 31, 2021, we had cash of $1.9 million. On April 19, 2022, we closed the April Private Placement from which we received
aggregate net proceeds of approximately $6.9 million, after deducting placement agent fees and other offering expenses. On August&nbsp;11,
2022, we closed the August Private Placement from which we received approximately $8.7&nbsp;million in net proceeds, after deducting placement
agent fees and other initial offering expenses. We estimate that, based on our existing cash as of the date of this registration statement,
we will have cash on hand sufficient to fund our operations for at least the 12 months following the date of this registration statement.
We believe that we will need to raise substantial additional capital to fund our continuing operations and the development and commercialization
of our current product candidates and future product candidates in the long-term. Our business or operating plan may change as a result
of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. We expect to finance our subsequent
cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution
arrangements, as well as other collaborations, strategic alliances and licensing arrangements or any combination of these approaches.
In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently envisioned, and
this would require additional capital.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">However, we may not be able to secure funding
when we need it or on favorable terms and we may not be able to raise sufficient funds to commercialize our current and future product
candidates we intend to develop. Our ability to raise additional capital may be adversely impacted by potential worsening global economic
conditions and the recent disruptions to and volatility in the credit and financial markets in the United&nbsp;States and worldwide, including
the trading price of common stock, resulting from the ongoing COVID-19 pandemic. Our future capital requirements will depend on many factors,
including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical development and clinical trials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies for our vaccine candidates, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the cost of building a sales force in anticipation of any product commercialization;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for any of our vaccine candidates for which we receive marketing approval;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>any product liability or other lawsuits related to our products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD STYLE="text-align: justify">the expenses needed to attract, hire and retain skilled personnel;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the revenue, if any, received from commercial sales, or sales to foreign governments, of our vaccine candidates for which we may receive marketing approval;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing of any patents or other intellectual property rights;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the expenses needed to attract, hire and retain skilled personnel;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the costs of operating as a public company; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 24px">&nbsp;</TD>
    <TD STYLE="width: 24px">&#9679;</TD>
    <TD>the impact of the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to raise additional funds will depend
on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available
on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in
sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization
of our vaccine candidates or other research and development initiatives. Our license agreements may also be terminated if we are unable
to meet the payment obligations or milestones under the agreements. We could be required to seek collaborators for our vaccine candidates
at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, or relinquish
or license on unfavorable terms our rights to our vaccine candidates in markets where we otherwise would seek to pursue development or
commercialization ourselves.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may consider strategic alternatives in order to maximize stockholder
value, including financings, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business. We may not
be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may have an adverse impact
on our vaccine candidates.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may consider all strategic alternatives that
may be available to us to maximize stockholder value, including financings, strategic alliances, licensing arrangements, acquisitions
or the possible sale of our business.Our exploration of various strategic alternatives may not result in any specific action or transaction.
To the extent that this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction.
There can be no assurance that we will enter into any transaction as a result of the engagement. Furthermore, if we determine to engage
in a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price.
We also cannot predict the impact on our stock price if we fail to enter into a transaction.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we face significant competition in
seeking appropriate strategic partners, and the negotiation process is time-consuming and complex. Moreover, we may not be successful
in our efforts to establish a strategic partnership or other alternative arrangements for our vaccine candidates because they may be deemed
to be at too early of a stage of development for collaborative effort, and third parties may not view our vaccine candidates as having
the requisite potential to demonstrate safety and efficacy. Any delays in entering into new strategic partnership agreements related to
our vaccine candidates could delay the development and commercialization of our vaccine candidates in certain geographies for certain
indications, which would harm our business prospects, financial condition and results of operations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we license products or businesses, we may not
be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company
culture. We cannot be certain that, following a strategic transaction or license, we will achieve the results, revenue or specific net
income that justifies such transaction.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Raising additional capital may cause dilution to our existing
stockholders and investors, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms
to us.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may seek additional capital through a variety
of means, including through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing,
distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, or through the issuance of shares under other types of contracts, or upon the exercise or conversion of outstanding options,
warrants, convertible debt or other similar securities, the ownership interests of our stockholders will be diluted, and the terms of
such financings may include liquidation or other preferences, anti-dilution&nbsp;rights, conversion and exercise price adjustments and
other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to
those of our holders of common stock in terms of the payment of dividends or in the event of a liquidation. In addition, debt financing,
if available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt,
making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security interests
in our assets. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution or licensing arrangements
with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidates
or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
when needed, we may need to curtail or cease our operations.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Due to the significant resources required for the development
of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates.
Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine
candidates that may be more profitable or for which there is a greater likelihood of success.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Due to the significant resources required for
the development of our vaccine candidates, we must decide which vaccine candidates to pursue and advance and the amount of resources to
allocate to each. Our decisions concerning the allocation of research, development, management and financial resources toward particular
vaccine candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.
Similarly, our potential decisions to delay, terminate, license or collaborate with third parties in respect of certain vaccine candidates
may subsequently also prove to be less than optimal and could cause us to miss valuable opportunities. If we make incorrect determinations
regarding the viability or market potential of any of our vaccine candidates or misread trends in the biopharmaceutical industry, in particular
for vaccines, our business could be seriously harmed. As a result, we may fail to capitalize on viable commercial products or profitable
market opportunities, be required to forego or delay pursuit of opportunities with other vaccine candidates that may later prove to have
greater commercial potential than those we choose to pursue or relinquish valuable rights to such vaccine candidates through collaboration,
licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain
sole development and commercialization rights.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have identified weaknesses in our internal controls, and we
cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in
the future.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a public company, we are subject to the reporting
requirements of the Exchange Act, and the Sarbanes-Oxley Act. We expect that the requirements of these rules and regulations will continue
to increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and
place significant strain on our personnel, systems and resources.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Sarbanes-Oxley Act requires, among other things,
that we maintain effective disclosure controls and procedures, and internal control over financial reporting.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not yet have effective disclosure controls
and procedures, or internal controls over all aspects of our financial reporting. We are continuing to develop and refine our disclosure
controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we will
file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our management
has deemed certain conditions to be material weaknesses in our internal controls. For example, we failed to employ a sufficient number
of staff to maintain optimal segregation of duties and to provide optimal levels of oversight in order to process financial information
in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. In addition, we do not
yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions. Our management
is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule&nbsp;13a-15(f)&nbsp;under
the Exchange&nbsp;Act. We will be required to expend time and resources to further improve our internal controls over financial reporting,
including by expanding our staff to include financial consultants and other qualified resources, which we commenced during the fourth
quarter of 2021. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify
or avoid material weaknesses in the future.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our current controls and any new controls that
we develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international
expansion. Further, weaknesses in our disclosure controls or our internal control over financial reporting may be discovered in the future.
Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm
our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements
for prior periods. Any failure to implement and maintain effective internal control over financial reporting could also adversely affect
the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting
that we will eventually be required to include in our periodic reports that will be filed with the SEC.&nbsp;Ineffective disclosure controls
and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial
and other information, which would likely have a negative effect on the market price of our common stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are not currently required to comply with the
SEC rules that implement Section&nbsp;404 of the Sarbanes-Oxley Act and are therefore not required to make a formal assessment of the
effectiveness of our internal control over financial reporting for that purpose. We will be required to provide an annual management report
on the effectiveness of our internal control over financial reporting commencing with our second annual report on Form&nbsp;10-K.&nbsp;Our
independent registered public accounting firm is not required to audit the effectiveness of our internal control over financial reporting
until after we are no longer an &ldquo;emerging growth company&rdquo; as defined in the JOBS Act. At such time, our independent registered
public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control
over financial reporting is documented, designed or operating.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our ability to use our net operating loss carryforwards and certain
other tax attributes may be limited, each of which could harm our business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of December&nbsp;31, 2021, we had U.S.&nbsp;federal
and state net operating loss carryforwards of approximately $4.9&nbsp;million and $5.1&nbsp;million, respectively. Under Sections 382
and 383 of the Internal Revenue Code, or the Code, if a corporation undergoes an &ldquo;ownership change,&rdquo; the corporation&rsquo;s
ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research
tax credits, to offset its post-ownership change income and taxes may be limited. In general, an ownership change will occur when the
percentage of the Corporation&rsquo;s ownership (by value) of one or more &ldquo;5-percent stockholders&rdquo; (as defined in the Code)
has increased by more than 50 percent over the lowest percentage owned by such stockholders at any time during the prior three&nbsp;years
(calculated on a rolling basis). Similar rules may apply under state tax laws. An entity that experiences an ownership change generally
will be subject to an annual limitation on its pre-ownership change tax loss and credit carryforwards equal to the equity value of the
corporation immediately before the ownership change, multiplied by the long-term, tax-exempt rate posted monthly by the U.S.&nbsp;Internal
Revenue Service (subject to certain adjustments). The annual limitation would be increased each year to the extent that there is an unused
limitation in a prior year. In the event that it is determined that we have in the past experienced an ownership change as a result of
transactions in our stock, or if we experience one or more ownership changes as a result of future transactions in our stock, then we
may be limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable
income that we earn. Any limitations on the ability to use our net operating loss carryforwards and other tax assets could harm our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our insurance coverage may be inadequate or expensive.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are subject to claims in the ordinary course
of business. These claims may involve substantial amounts of money and involve significant defense costs. It is not possible to prevent
or detect all activities giving rise to claims and the precautions we take may not be effective in all cases. We maintain voluntary and
required insurance coverage, including, among others, general liability, property, director and officer, business interruption, cyber
and data breach. Our insurance coverage is expensive and maintaining or expanding our insurance coverage may have an adverse effect on
our results of operations and financial condition.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our insurance coverage may be insufficient to
protect us against all losses and costs stemming from operational and technological failures and we cannot be certain that such insurance
will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any
future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence
of changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance
requirements, could have an adverse effect on our business, financial condition and results of operations.</P>

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to the Development of our Product Candidates</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We depend entirely on the success of a limited number of product
candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval
for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never
become profitable.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not have any products that have received
regulatory approval and may never be able to develop marketable product candidates. We expect that a substantial portion of our efforts
and expenses over the next few&nbsp;years will be devoted to the development of our product candidates; specifically, the commencement
of Phase&nbsp;I clinical trials for our vaccine candidates. As a result, our business currently depends heavily on the successful development,
regulatory approval and, if approved, commercialization of these product candidates. We cannot be certain that our product candidates
will receive regulatory approval or will be successfully commercialized even if they receive regulatory approval. The research, testing,
manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain,
subject to comprehensive regulation by the FDA and similar foreign regulatory authorities. Before obtaining regulatory approvals for the
commercial sale of any product candidate, we must demonstrate through pre-clinical studies and clinical trials that the product candidate
is safe and effective for use in each target indication. Vaccine development is a long, expensive and uncertain process, and delay or
failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates in the
United&nbsp;States will prevent us from commercializing and marketing our product candidates. The success of our product candidates will
depend on several additional factors, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">completing clinical trials that demonstrate their efficacy and safety;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">receiving marketing approvals from applicable regulatory authorities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">completing any post-marketing studies required by applicable regulatory authorities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">establishing commercial manufacturing capabilities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">launching commercial sales, marketing and distribution operations;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the prevalence and severity of adverse events experienced with our product candidates;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">acceptance of our product candidates by patients, the medical community and third-party payors;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">a continued acceptable safety profile following approval;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">obtaining and maintaining healthcare coverage and adequate reimbursement for our product candidates;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>competing effectively with other therapies, including with respect to the sales and marketing of our product candidates, if approved; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of these factors are beyond our control,
including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual
property rights and changes in the competitive landscape. It is possible that none of our product candidates will ever obtain regulatory
approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in
a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory
approval or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and results
of operations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I></I></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The marketing approval process of the FDA is lengthy, time consuming
and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future
product candidates we intend to develop, our business will be substantially harmed.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are at a very early stage of development for
all of our product candidates. The product candidates we intend to develop have not gained marketing approval in the U.S., and we cannot
guarantee that we will ever have marketable products. Our business is substantially dependent on our ability to complete the development
of, obtain marketing approval for, and successfully commercialize our current and future product candidates in a timely manner. We cannot
commercialize our product candidates in the United&nbsp;States without first obtaining approval from the FDA to market each product candidate.
Our product candidates could fail to receive marketing approval for many reasons, including among others:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the FDA may disagree with the design or implementation of our clinical trials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>Our clinical trials for our product candidate(s)&nbsp;must be successful if we are to seek and obtain regulatory marketing application through the submission of a new Biological License Application (BLA) and marketing authorization application (MAA) with the U.S.&nbsp;Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. Advanced clinical trials are often not successful even if prior trials were successful, and even if we are able to conduct advanced clinical trials and those trials are successful, we may not obtain necessary regulatory approvals for our product candidate(s)&nbsp;or we may be unable to successfully commercialize our products even if we receive the necessary regulatory approvals</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, the process of seeking regulatory
approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort and expense
incurred, approval is never guaranteed. If we are not successful in obtaining timely approval of our product candidates from the FDA,
we may never be able to generate significant revenue and may be forced to cease operations. The new Biological License Application, or
BLA, process is costly, lengthy and uncertain. Any BLA application filed by us will have to be supported by extensive data, including,
but not limited to, technical, pre-clinical, clinical, manufacturing and labelling data, to demonstrate to the FDA&rsquo;s satisfaction
the safety and efficacy of the product for its intended use.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to commence a clinical trial in the United&nbsp;States,
we will be required to seek FDA acceptance of an IND for each of our product candidates. We cannot be sure any IND we submit to the FDA,
or any similar clinical trial application we submit in other countries, will be accepted. If we will be required by regulatory authorities
to conduct additional preclinical testing prior to filing an IND or similar application to clinically evaluate any of our product candidates,
this may result in delay in our product candidate development. The results of any such preclinical testing may not be positive and may
not support an application to study any of our product candidates in additional clinical trials.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is possible that the FDA or EMA will not view
our ongoing or planned trials as providing adequate support for future clinical trials or for an application for marketing approval, for
any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results. If we
are unable to confirm or replicate the results of our trials in larger patient group or if negative results are obtained, we would likely
be further delayed or prevented from advancing further clinical development any of our product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the FDA or EMA may disagree with
the sufficiency of our proposed reliance upon the preclinical, manufacturing or clinical data generated by third-party academic-sponsored
trials, or our interpretation of preclinical, manufacturing or clinical data from our ongoing trials. If so, the FDA or EMA may require
us to obtain and submit additional preclinical, manufacturing or clinical data.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Obtaining approvals from the FDA and from the
regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome. The FDA and other agencies
could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming
actions, or it could simply deny our applications. In addition, even if we obtain a BLA approval or pre-market approvals in other countries,
the approval could be revoked or other restrictions imposed if post-market data demonstrate safety issues or lack of effectiveness. We
cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals, our financial
condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited. Additionally,
even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful
commercialization or profitability.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may encounter substantial delays in completing our clinical
studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of
applicable regulatory authorities.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is impossible to predict if or when our current
or future product candidates, will prove safe or effective in humans or&nbsp;will&nbsp;receive regulatory approval. Before obtaining marketing
approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate
the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome.
We&nbsp;cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A&nbsp;failure of
one or more clinical studies can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development
include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">delays in reaching, or failing to reach, a consensus with regulatory agencies on study design;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: left">delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">delays in recruiting a sufficient number of suitable patients to participate in our clinical studies;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">failure by our&nbsp;CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">failure to perform in accordance with the FDA&rsquo;s good clinical practices, or GCPs, or applicable regulatory guidelines in other countries;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">delays in having patients complete participation in a study or return for post-treatment follow-up;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">clinical study sites or patients dropping out of a study;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">delay or failure to address any patient safety concerns that arise during the course of a trial;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">unanticipated costs or increases in costs of clinical trials of our product candidates;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">occurrence of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits; or</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We could also encounter delays if a clinical trial
is suspended or terminated by us, by the Institutional Review Board, or IRB, or the Ethics Commission of the institutions in which such
trials are being conducted, by an independent Safety Review Board, or SRB, for such trial or by the FDA or other regulatory authorities.
Such authorities&nbsp;may&nbsp;suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical
trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site
by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects,
failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate
funding to continue the clinical trial.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any inability to successfully complete pre-clinical
and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory
and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes to our product candidates,
we may need to conduct additional studies to bridge our modified product candidates to earlier versions.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical study delays could also 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, which could impair our ability to successfully commercialize our product candidates.&nbsp;In addition, any delays in completing
our clinical trials will increase our costs, slow down&nbsp;our&nbsp;product candidates&rsquo; development and approval process and jeopardize
our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business, financial condition
and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may
also ultimately lead to the denial of regulatory approval of our product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The outcome of pre-clinical studies and 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. Further, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many
companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless
failed to obtain marketing approval.&nbsp;If the results of our clinical studies are inconclusive or if there are safety concerns or adverse
events associated with our product candidates, we may:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">be delayed in obtaining marketing approval for our product candidates, if approved at all;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">obtain approval for indications or patient populations that are not as broad as intended or desired;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">be required to change the way the product is administered;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">be sued; or</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">experience damage to our reputation.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, our product candidates could potentially
cause other adverse events that have not yet been predicted. The inclusion of ill patients in our clinical studies may result in deaths
or other adverse medical events due to other therapies or medications that such patients may be using. As described above, any of these
events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize
our products.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Obtaining and maintaining regulatory approval
of our vaccine candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any
other jurisdiction, while 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 vaccine candidate, comparable regulatory authorities
in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the vaccine candidate in those countries. Approval
procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those
in the United&nbsp;States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction
may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United&nbsp;States, a vaccine
candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we
intend to charge for our products is also subject to approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may also submit marketing applications in other
countries. Regulatory authorities in jurisdictions outside of the United&nbsp;States have requirements for approval of vaccine candidates
with which we must comply prior to marketing in those jurisdictions. 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 receive applicable
marketing approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates
will be harmed.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Modifications to our products may require new BLA approvals.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once a particular product receives FDA approval,
expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals, including
additional IND and BLA submissions and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.
If the FDA requires new approvals for a particular use or indication, we may be required to conduct additional clinical studies, which
would require additional expenditures and harm our operating results. If the products are already being used for these new indications,
we may also be subject to significant enforcement actions. Conducting clinical trials and obtaining approvals can be a time-consuming
process, and delays in obtaining required future approvals could adversely affect our ability to introduce new or enhanced products in
a timely manner, which in turn would harm our future growth.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I></I></B></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Additional delays to the completion of clinical studies may result
from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences
in the given trial</I></B><I>.</I></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Each modification to the protocol during a clinical
trial has to be submitted to the FDA.&nbsp;This could result in the delay or halt of a clinical trial while the modification is evaluated.
In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the
clinical trial are not poolable because the same protocol was not used throughout the trial. This might require the enrollment of additional
subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product. Any such delay could have
a material adverse effect on our business and results of operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>There can be no assurance that the data generated from our clinical
trials using modified protocols will be acceptable to the FDA or other regulatory authorities.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There can be no assurance that the data generated
using modified protocols will be acceptable to the FDA or other regulatory authorities or that if future modifications during the trial
are necessary, that any such modifications will be acceptable to the FDA or other regulatory authorities. If the FDA or other regulatory
authorities believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they
evaluate additional information regarding the change.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Serious injury or death resulting from a failure
of our product candidates during current or future clinical trials could also result in the FDA or other regulatory authority delaying
our clinical trials or denying or delaying approval of a product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even though an adverse event may not be the result
of the failure of our product candidate, the FDA or other regulatory authority could delay or halt a clinical trial for an indefinite
period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any delay or termination of our current or future
clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from the FDA
or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial,
and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase
in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization
of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will depend on enrollment and retention of patients in our
clinical trials for our product candidates. If we experience delays or difficulties enrolling or retaining patients in our clinical trials,
our research and development efforts and business, financial condition, and results of operations could be materially adversely affected.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Successful and timely completion of clinical trials
will require that we enroll and retain a sufficient number of patient candidates. Any clinical trials we conduct may be subject to delays
for a variety of reasons, including as a result of patient enrollment taking longer than anticipated, patient withdrawal, or adverse events.
These types of developments could cause us to delay the trial or halt further development.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our clinical trials will compete with other clinical
trials that are in the same therapeutic areas as our product candidates, and this competition reduces the number and types of patients
available to us, as some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by
one of our competitors. Moreover, enrolling patients in clinical trials for diseases in which there is an approved standard of care is
challenging, as patients will first receive the applicable standard of care. Many patients who respond positively to the standard of care
do not enroll in clinical trials. This may limit the number of eligible patients able to enroll in our clinical trials who have the potential
to benefit from our product candidates and could extend development timelines or increase costs for these programs. Patients who fail
to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates. However, these
prior treatment regimens may render our therapies less effective in clinical trials.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because the number of qualified clinical investigators
and clinical trial sites is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our
competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Patient enrollment depends on many factors, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the size and nature of the patient population;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the severity of the disease, condition or infection under investigation;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">eligibility criteria for the trial;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the proximity of patients to clinical sites;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the design of the clinical protocol;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the ability to obtain and maintain patient consents;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">perceived risks and benefits of the product candidate under evaluation;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the ability to recruit clinical trial investigators with the appropriate competencies and experience;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the availability of competing clinical trials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the availability of such patients during the COVID-19 pandemic;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the availability of new drugs approved for the indication the clinical trial is investigating; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">clinicians&rsquo; and patients&rsquo; perceptions as to the potential advantages of the drug being studied in relation to other available therapies.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These factors may make it difficult for us to
enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical
trial of our product candidates will increase our costs, slow down our product candidate development and approval process, and delay or
potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause, or lead
to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our
product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Conducting successful clinical studies may require the enrollment
of large numbers of patients, and suitable patients may be difficult to identify and recruit.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Patient enrollment in clinical trials and completion
of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial
protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability
of appropriate clinical trial investigators; support staff; and the proximity of patients to clinical sites and ability to comply with
the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged
from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up
to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are
not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to
participate in contemporaneous clinical trials of competitive products.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The results of our future clinical trials may not support our
product candidates&rsquo; claims or may result in the discovery of unexpected adverse side effects.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if our clinical trials are completed as planned,
we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will agree with
our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will
be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical
trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses. If the FDA concludes
that the clinical trials for any product for which we might seek approval, has failed to demonstrate safety and effectiveness, we would
not receive FDA approval to market that product in the United&nbsp;States for the indications sought.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, such an outcome could cause us to
abandon a product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing
of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues. It
is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of our product
candidates&rsquo; profiles.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</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"><B><I>Adverse events involving our products may lead the FDA or other
regulatory authorities to delay or deny approval for our products or result in product recalls that could harm our reputation, business
and financial results.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, if any of our product candidates
receives marketing approval, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, and other non-U.S.&nbsp;regulatory
authorities could impose other specific obligations as a condition of approval to ensure that the benefits outweigh its risks, which may
include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan
to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if we or
others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences
could result, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">regulatory authorities may suspend or withdraw approvals of such a product candidate;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">regulatory authorities may require additional warnings or limitations of use in product labeling;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>we may be required to change the way a product candidate is distributed, dispensed, or administered or conduct additional clinical trials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">we could be sued and held liable for harm caused to patients; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">our reputation may suffer.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any of these events could prevent us from achieving
or maintaining market acceptance of our product candidates and could significantly harm our business, prospects, financial condition and
results of operations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once a product receives FDA approval, the agency
has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects
in design or manufacture. The authority to require a recall must be based on an FDA finding that there is a reasonable probability that
the product would cause serious injury or death. Manufacturers may, under their own initiative, recall a product if any material deficiency
in a product is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side
effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues.
Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and
results of operations. The FDA requires that certain classifications of recalls be reported to FDA within ten working&nbsp;days after
the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.&nbsp;We
may initiate voluntary recalls involving our products in the future. A future recall announcement could harm our reputation with customers
and negatively affect our sales. In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report
the recalls when they were conducted.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if we obtain regulatory approval of our vaccine candidates,
the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in
the medical community.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if any of our vaccine candidates receive
marketing approval, they may fail to receive recommendations for use by regulators or advisory boards that recommend vaccines, or gain
market acceptance by physicians, patients, third-party payors and others in the medical community. If such vaccine candidates do not achieve
an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance
of any vaccine candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>receiving CDC and ACIP recommendations for use, as well as recommendations of comparable foreign regulatory and advisory bodies;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">prevalence and severity of the disease targets for which our vaccine candidates are approved;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">physicians, hospitals, third-party payors and patients considering our vaccine candidates as safe and effective;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the potential and perceived advantages of our vaccine candidates over existing vaccines, including with respect to spectrum coverage or immunogenicity;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the prevalence and severity of any side effects;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">product labeling or product insert requirements of the FDA or comparable foreign regulatory and advisory bodies;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>limitations or warnings contained in the labeling approved by the FDA or comparable foreign regulatory and advisory bodies;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the timing of market introduction of our vaccine candidates as well as competitive products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the cost of treatment in relation to alternative treatments;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the availability of coverage and adequate reimbursement and pricing by third-party payors, including government authorities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the willingness of patients to pay&nbsp;out-of-pocket&nbsp;in the absence of coverage and adequate reimbursement by third-party payors, including government authorities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>relative convenience and ease of administration, including as compared to competitive vaccines and alternative treatments; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the effectiveness of our sales and marketing efforts.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, the CDC and ACIP develop
vaccine recommendations for both children and adults, as do similar agencies around the world. To develop its recommendations, ACIP forms
working groups that gather, analyze and prepare scientific information. The ACIP also considers many of the factors above, as well as
myriad additional factors such as the value of vaccination for the target population regarding the outcomes, health economic data and
implementation issues. ACIP recommendations are also made within categories, such as in an age group or a specified risk group. For example,
the ACIP may determine that a preferred recommendation in a smaller child population may be more economical than recommending vaccinations
for a larger adult population, which could adversely impact our market opportunity.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">New pediatric vaccines that receive an ACIP preferred
recommendation are almost universally adopted, and adult vaccines that receive a preferred recommendations are widely adopted. For example,
in 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults ages 65&nbsp;years and older against pneumococcal
disease, which caused Prevnar 13 to become the standard of care along with continued use of Pneumovax 23. ACIP can also modify its preferred
recommendation. For instance, in June&nbsp;2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend Prevnar
13 for adults 65 and older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation,
which means the decision to vaccinate should be made at the individual level between health care providers and their patients. Pfizer
recently noted that this revised recommendation is expected to have a negative effect on Prevnar 13 revenue for future periods.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our vaccine candidates are approved but fail
to receive CDC and ACIP recommendations, or recommendations of other comparable foreign regulatory and advisory bodies, or achieve market
acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able
to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance
over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or
render our products obsolete.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Obtaining regulatory approval for clinical trials of our vaccine
candidates 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></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pediatric vaccine candidates&rsquo; development
may require additional studies to determine safe dosing and long-term monitoring. These additional studies may require investment of significant
additional resources beyond those required for regulatory approval of the vaccines in adults. Approval of our vaccine candidates may be
delayed due to these additional requirements and this may have an adverse effect on the commercial prospects of our vaccine candidates,
especially our pediatric vaccine candidate, BWV-201, 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.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if we are able to commercialize our product candidates,
such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,
which would harm our business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The regulations that govern marketing approvals,
pricing, coverage and reimbursement for new drugs vary widely from country to country. In the United&nbsp;States, new and future legislation
may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.
Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins
after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject
to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for
a vaccine in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time
periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations
may hinder our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing
approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to commercialize our current and any
future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products
and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other
third-party payors. Third-party payors decide which vaccines they will pay for and establish reimbursement levels. A significant trend
in the U.S.&nbsp;healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to
control costs by limiting coverage and the amount of payment for particular vaccines. Increasingly, third-party payors are requiring that
drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage
and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement
may not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate
for which we obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may
not be able to successfully commercialize any product candidate for which we obtain marketing approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There may be significant delays in obtaining coverage
and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved
by the FDA or similar regulatory authorities outside the United&nbsp;States. Moreover, eligibility for coverage and 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 reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may
not be made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under
which it is used may be based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing
payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs
or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold
at lower prices than in the United&nbsp;States. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations
in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded
programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our
ability to raise capital needed to commercialize our approved products and our overall financial condition.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Any product candidate for which we obtain marketing approval
could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with
regulatory requirements or if we experience unanticipated problems with our products.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any product candidate for which we obtain marketing
approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities
for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements
include submissions of promotional materials and safety and other post-marketing information and reports, registration and listing requirements,
current Good Manufacturing Practice (&ldquo;cGMP&rdquo;) requirements for product facilities, quality assurance and corresponding maintenance
of records and documents and requirements regarding the distribution of samples to physicians and related recordkeeping. Even if marketing
approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may
be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the
safety or efficacy of the medicine. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are
marketed only for the approved indications and in accordance with the provisions of the approved labeling. However, companies may share
truthful and not misleading information that is otherwise consistent with the product&rsquo;s FDA approved labeling. The FDA imposes stringent
restrictions on manufacturers&rsquo; communications regarding off-label use and if we do not comply with these restrictions, we may be
subject to enforcement actions.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, later discovery of previously unknown
problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements,
may result in, among other things:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">restrictions on such products, manufacturers or manufacturing processes or facilities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">restrictions on the labeling, marketing, distribution or use of a product;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">warning or untitled letters;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">withdrawal or recall of the products from the market;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">refusal to approve pending applications or supplements to approved applications that we submit;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">fines, restitution or disgorgement of profits or revenue;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">suspension or withdrawal of marketing approvals;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">refusal to permit the import or export of our products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">product seizure; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">injunctions or the imposition of civil or criminal penalties.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Failure to obtain regulatory approvals in foreign jurisdictions
will prevent us from marketing our products internationally.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We intend to market future products in international
markets. In order to market our future products in regions such as the European Economic Area, or EEA, Asia Pacific, or APAC, and many
other foreign jurisdictions, we must obtain separate regulatory approvals.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For example, in the EEA, medicinal products can
only be commercialized after obtaining a Marketing Authorization, or MA.&nbsp;Before granting the MA, the European Medicines Agency or
the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of
scientific criteria concerning its quality, safety and efficacy. In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA,
of the Ministry of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug
product may be marketed in Japan.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have had limited interactions with foreign
regulatory authorities. The approval procedures vary among countries and can involve additional clinical testing, and the time required
to obtain approval may differ from that required to obtain FDA approval. Moreover, clinical studies conducted in one country may not be
accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other
countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign
countries or by the FDA.&nbsp;However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on
the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.
We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even
if we file we may not receive necessary approvals to commercialize our products in any market.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If our products do not receive favorable third-party reimbursement,
or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not generate significant revenues.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to commercialize our products will
depend in part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations and products and related
treatments are obtained by governmental authorities, private health insurers and other organizations, such as Health Maintenance Organizations,
or HMOs. Reimbursement from third parties depends greatly on our ability to present data which demonstrate positive outcomes and reduced
utilization of other products or services as well as cost data which show that treatment costs using the new product are equal to or less
than what is currently covered for other products. If our products do not receive favorable third-party reimbursement and patients are
unwilling or unable to pay for our products out-of-pocket, it could limit our revenues and harm our business.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The continuing efforts of government and insurance
companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect
our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative
partners and the availability of capital. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals
is subject to government control. In the United&nbsp;States, recent federal and state government initiatives have been directed at lowering
the total cost of health care. In March&nbsp;2010, President Obama signed into law the Patient Protection and Affordable Care Act, a sweeping
law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud
and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry
and impose additional health policy reforms. Federal and state legislatures will likely continue to focus on health care reform, controlling
the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems. While we cannot predict whether any such
legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially harm our business,
financial condition and results of operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to our Business and Industry</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be adversely affected by the ongoing coronavirus pandemic.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The outbreak of the novel coronavirus COVID-19
(&ldquo;COVID-19&rdquo;) has evolved into a global pandemic. The coronavirus has spread to many regions of the world. The extent to which
the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be
accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus
or treat its impact, among others.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a result of the continuing spread of COVID-19,
our business operations could be delayed or interrupted. Currently, we operate virtually, i.e., our program activities are and will continue
to be carried out, on our behalf, by competent contract research organizations (CROs) with expertise in pre-clinical, clinical and/or
chemistry and manufacturing areas. Due to COVID-19, our planned project timelines may be delayed due to reduced availability of human
resources or critical supplies needed to carry out such plans. Due to shelter-in-place/stay-at-home&nbsp;orders and other government restrictions,
our employees conducting research and development or manufacturing activities at external vendor locations across the globe may not be
able to access their laboratory or manufacturing space which may result in our core activities being significantly limited or curtailed,
possibly for an extended period of time.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, our clinical trials may be affected
by the COVID-19 pandemic. Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of
clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,
federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the COVID-19
pandemic. If the coronavirus continues to spread, some participants and clinical investigators may not be able to execute clinical trial
protocols per the expected timelines. The new mutations of the virus may also make it harder for us to predict the exact impact (if any)
on the progression of COVID-19 on our development programs. For example, quarantines or other travel limitations (whether voluntary or
required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable
to conduct our clinical trials. Further, if the spread of the COVID-19 pandemic continues and our operations are adversely impacted, we
risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully
recoverable or adequately covered by insurance.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Infections and deaths related to the pandemic
may disrupt the United&nbsp;States&rsquo; healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources
away from, or materially delay FDA review or review by other regulatory agencies and/or approval with respect to, our clinical trials.
It is unknown how long these disruptions could continue, were they to occur. Any elongation or&nbsp;de-prioritization&nbsp;of our clinical
trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product
candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The spread of the coronavirus, which has caused
a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have
a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult
to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which
may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained
adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of
our common stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ultimate impact of the current pandemic, or
any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts
on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects
could have a material impact on our operations, and we will continue to monitor the situation closely.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be adversely affected by the ongoing monkeypox outbreak.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The monkeypox outbreak of 2022 has spread to many
regions of the world, including the United&nbsp;States. The extent to which the monkeypox outbreak impacts our business and operating
results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that
may emerge, if the outbreak is ultimately upgraded to a pandemic, and the actions to contain <FONT STYLE="font-family: Times New Roman, Times, Serif">monkeypox</FONT>
or treat its impact, <FONT STYLE="font-family: Times New Roman, Times, Serif">among others. As of August&nbsp;2022, it is still classified
as an outbreak by the World Health Organization, but this may be upgraded to a pandemic in the event of future spread of the disease.</FONT></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a result of the continuing spread of monkeypox
infections, our business operations could be delayed or interrupted. Currently, we operate virtually, i.e., our program activities are
and will continue to be carried out on our behalf, by competent contract research organizations (CROs) with expertise in pre-clinical,
clinical and/or chemistry and manufacturing areas. Due to monkeypox, our planned project timelines may be delayed due to reduced availability
of human resources or critical supplies needed to carry out such plans. In the event of any future shelter-in-place/stay-at-home&nbsp;orders
and other government restrictions, our employees conducting research and development or manufacturing activities at external vendor locations
across the globe may not be able to access their laboratory or manufacturing space which may result in our core activities being significantly
limited or curtailed, possibly for an extended period of time.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, our clinical trials may be affected by
the monkeypox outbreak. Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of
clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,
federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the outbreak.
If monkeypox continues to spread and regulations are developed and enacted, some participants and clinical investigators may not be able
to execute clinical trial protocols per the expected timelines. Further, if the spread of the monkeypox outbreak continues and our operations
are adversely impacted, we risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost
increases may not be fully recoverable or adequately covered by insurance.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Infections and deaths related to this outbreak may
disrupt the United&nbsp;States&rsquo; healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources
away from, or materially delay FDA review or review by other regulatory agencies and/or approval with respect to, our clinical trials.
It is unknown how long these disruptions could continue, were they to occur. Any elongation or&nbsp;de-prioritization&nbsp;of our clinical
trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product
candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The spread of monkeypox, which may cause a broad
impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have a material
economic effect on our business in the event of continued spread of the virus. While the potential economic impact brought by and the
duration may be difficult to assess or predict, it may result in disruption of global financial markets, which may reduce our ability
to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting
from the spread of monkeypox could materially and adversely affect our business and the value of our common stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif">The ultimate
impact of the current outbreak, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent
of potential delays or impacts on our business, our clinical trials, our</FONT> research programs, healthcare systems or the global economy
as a whole. However, these effects could have a material impact on our operations, and we will continue to monitor the situation closely.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our reliance on third parties heightens the risks faced by our
business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We rely on suppliers, vendors and partners for
certain key aspects of our business, including support for information technology systems and certain human resource functions. We do
not control these partners, but we depend on them in ways that may be significant to us. If these parties fail to meet our expectations
or fulfill their obligations to us, we may fail to receive the expected benefits. In addition, if any of these third parties fails to
comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible
for such violations as well. This risk is particularly serious in emerging markets, where corruption is often prevalent and where many
of the third parties on which we rely do not have internal compliance resources comparable to our own. Any such failures by third parties,
in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We rely on, and intend to continue to rely on third parties to
conduct our pre-clinical testing, research and clinical trials, and those third parties may not perform satisfactorily, including failing
to meet deadlines for the completion of such trials, research or testing.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have been relying on third parties for our
preclinical studies, and we expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical
data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects
of our research and pre-clinical testing. These third parties may terminate their engagements with us at any time. If these third parties
do not successfully carry out their duties, meet expected deadlines or conduct our studies 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. Furthermore, these third
parties may also have relationships with other entities, some of which may be our competitors. If we are required to enter into alternative
arrangements, it could delay our product development activities.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our reliance on third parties for research and
development activities will 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 and other international regulatory authorities require us to comply with GCP standards
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. We also are required to register ongoing clinical
trials and post the results of completed clinical trials on a government-sponsored database, available at <I>www.clinicaltrials.gov</I>,
within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Upon commercialization of our products, we may be dependent on
third parties to market, distribute and sell our products.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to receive revenues may be dependent
upon the sales and marketing efforts of any future co-marketing partners and third-party distributors. At this time, we have not entered
into an agreement with any commercialization partner and only plan to do so prior to commercialization. If we fail to reach an agreement
with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it may
have a negative impact on our business, financial condition and results of operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have no experience manufacturing product candidates on a clinical
or commercial scale and will be dependent on third parties for the manufacture of our product candidates. If we experience problems with
any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell
any approved products.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not have any manufacturing facilities. We
expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply
of any product candidate for which we obtain marketing approval.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may be unable to establish agreements with
third-party manufacturers for clinical or commercial supply on terms favorable to us, or at all. Even if we are able to establish agreements
with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">reliance on the third party for regulatory compliance and quality assurance;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Third-party manufacturers may not be able to comply
with U.S.&nbsp;cGMPs or similar regulatory requirements outside the United&nbsp;States. Our failure, or the failure of our third-party
manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates
or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties,
delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and
criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any product that we develop may compete with other
product candidates and products for access to these manufacturing facilities. There are a limited number of manufacturers that operate
under cGMPs and that might be capable of manufacturing for us.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any performance failure on the part of our manufacturers,
including a failure that may not relate specifically to our product candidates or approved products, could delay clinical development
or marketing approval or adversely impact our ability to generate commercial sales. If our contract manufacturers cannot perform as agreed,
we may be required to replace that manufacturer.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our anticipated future dependence upon others
for the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability
to commercialize any product candidates that receive marketing approval on a timely and competitive basis.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Furthermore, we expect to rely on third parties
to release, label, store and distribute drug supplies for our clinical trials. Any performance failure on the part of these third parties,
including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development
or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, our manufacturers and suppliers may
experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of
supply of our product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Manufacturing&nbsp;risks may adversely affect our ability to
manufacture our product and could reduce our gross margin and profitability.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our business strategy depends on our ability to
manufacture our product candidates in sufficient quantities and on a timely basis so as to meet our obligations with respect to our clinical
trials and upon marketing approval, to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements
and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>quality or reliability defects in product components that we source from third-party suppliers, including&nbsp;manufacturing&nbsp;compliance with federal and state regulations;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">our failure to increase production of products to meet demand;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>our inability to modify production lines to enable us to efficiently produce future products or implement changes in current products in response to regulatory requirements; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">Potential damage to or destruction of our&nbsp;manufacturing&nbsp;equipment or&nbsp;manufacturing&nbsp;facility.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If demand for our product candidates increases
in the future, we will have to invest additional resources to purchase components, hire and train employees, and enhance our&nbsp;manufacturing&nbsp;processes.
If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins
could fluctuate or decline. In addition, although we expect some of our product candidates in development to share product features and
components,&nbsp;manufacturing&nbsp;of some of our product candidates may require the modification of our production lines, the hiring
of specialized employees, the identification of new suppliers for specific components, or the development of new&nbsp;manufacturing&nbsp;technologies.
It may not be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates
commercially viable. Any of these factors may affect our ability to manufacture our product and could reduce our gross margin and profitability.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We maintain single supply relationships for certain key components,
and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its&nbsp;manufacturing&nbsp;process
increases.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are dependent on sole suppliers or a limited
number of suppliers for certain components that are integral to its finished products. If these or other suppliers encounter financial,
operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish or qualify replacement
sources of supply and could face production interruptions, delays and inefficiencies. In addition, technology changes by our vendors could
disrupt access to required&nbsp;manufacturing&nbsp;capacity or require expensive, time consuming development efforts to adapt and integrate
new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipment and materials
in sufficient quantities to support our growth. Any one of these factors could harm our business and growth prospects.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may not be able to manage our&nbsp;manufacturing&nbsp;and
supply chain effectively, which would harm our results of operations.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We must accurately forecast our clinical trial
obligations, and, in the future, market demand, for our product candidates in order to have adequate product inventory available to fulfil
our timeline and customer orders timely. Our forecasts will be based on multiple assumptions that may cause our estimates to be inaccurate,
and thus affect our ability to ensure adequate manufacturing capability to satisfy product candidate needs or market demand. Any material
delay in our ability to obtain timely product inventories from our manufacturing facility and our ingredient suppliers could prevent us
from satisfying increased consumer demand for our products, resulting in material harm to our clinical trials, brand and business. In
addition, we will need to continuously monitor our inventory and product mix against forecasted demand to avoid having inadequate product
inventory or having too much product inventory on hand. If we are unable to manage our supply chain effectively, our operating costs may
increase materially.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may in the future have conflicts with our current or future
partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may in the future have conflicts with our current
or future partners or third party providers, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement
of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual
property developed during our collaboration. If any conflicts arise with any of our partners, such partner may act in a manner that is
adverse to our best interests. Any such disagreement could result in one or more of the following, each of which could delay or prevent
the development or commercialization of our current and future product candidates, and in turn prevent us from generating revenues:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">attempts by either party to terminate the agreement.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our product candidates may face competition sooner than anticipated
from biosimilar products.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if we are successful in achieving regulatory
approval to commercialize a product candidate faster than our competitors, our product candidates may face competition from biosimilar
products. In the United&nbsp;States, our product candidates are regulated by the FDA as biologic products and we intend to seek approval
for these product candidates pursuant to the BLA pathway. The Biologics Price Competition and Innovation Act&nbsp;of&nbsp;2009, or BPCIA,
created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway
establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar
as &ldquo;interchangeable&rdquo; based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar
product cannot be approved by the FDA until 12&nbsp;years after the original branded product was approved under a BLA.&nbsp;The law is
complex and is still being interpreted and implemented by the FDA.&nbsp;As a result, its ultimate impact, implementation, and meaning
are subject to uncertainty.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is a risk that any exclusivity we may be
afforded if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action,
the results of recent litigation, or otherwise, or that the FDA will not consider our product candidates to be reference products for
competing products, potentially creating the opportunity for generic or biosimilar competition sooner than anticipated. Moreover, the
extent to which a biosimilar product, once approved, will be substituted for any one of our reference products in a way that is similar
to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory
factors that are still developing. In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA
after completing its own preclinical studies and clinical trials. In such cases, any exclusivity to which we may be eligible under the
BPCIA would not prevent the competitor from marketing its product as soon as it is approved.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, critics of the 12-year exclusivity
period in the biosimilar pathway law will likely continue to seek to shorten the data exclusivity period and/or to encourage the FDA to
interpret narrowly the law&rsquo;s provisions regarding which new products receive data exclusivity. In December&nbsp;2019, the US agreed
to remove from the United&nbsp;States-Mexico-Canada Agreement a requirement for at least 10&nbsp;years of data exclusivity for biologic
products. Also, the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference
product&rsquo;s original 12-year exclusivity period (a concept known in the generic drug context as &ldquo;umbrella exclusivity&rdquo;).
If the FDA were to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the
exclusivity period, this could expose us to biosimilar competition at an earlier time. There also have been, and may continue to be, legislative
and regulatory efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization,
including efforts to lower standards for demonstrating biosimilarity or interchangeability, limit patents that may be litigated and/or
patent settlements and implement preferential reimbursement policies for biosimilars.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If competitors are able to obtain marketing approval
for biosimilars referencing our product candidates, if approved, such products may become subject to competition from such biosimilars,
with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete
with us in each indication for which our product candidates may have received approval.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our primary competitors have significantly greater resources
and experience than we do, which may make it difficult for us to successfully develop our vaccine candidates, or may result in others
discovering, developing or commercializing products before or more successfully than us.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The vaccine market is intensely competitive and
is dominated by a small number of multinational, globally established pharmaceutical corporations with significant resources; Pfizer,
Merck, GlaxoSmithKline and Sanofi together control approximately 75% of the global vaccine market. We may also face competition from many
different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private
research institutions. For example, Sanofi and SK Chemicals have partnered to develop a PCV, and Affinivax and Astellas have partnered
to develop an affinity-bound pneumococcal vaccine.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccine candidates that we successfully develop
and commercialize may compete with existing vaccines and new vaccines that may become available in the future. Many of our competitors
have substantially greater financial, lobbying, technical, human and other resources than we do and may be better equipped to develop,
manufacture and market technologically superior vaccines, including the potential that our competitors may develop chemical processes
or utilize novel technologies for developing vaccines that may be superior to those we employ. In addition, many of these competitors
have significantly greater experience than we have in undertaking preclinical testing and clinical trials of new products and in obtaining
regulatory approvals, including for many vaccine franchises. Accordingly, our competitors may succeed in obtaining FDA approval or a preferred
recommendation for their products. For example, Prevnar 13 obtained FDA approval for the prevention of invasive pneumococcal disease,
or IPD, in infants based on non-inferior IgG antibody responses relative to Prevnar, using the surrogate immune endpoints established
by the prior Prevnar field efficacy study. Pfizer is currently implementing a similar approach to development of its 20-valent PCV vaccine
candidate, and may have a more efficient path to regulatory approval given Pfizer&rsquo;s and the FDA&rsquo;s previous experience with
Prevnar 13.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of our competitors have established distribution
channels for the commercialization of their vaccine products, whereas we have no such established channels or capabilities. In addition,
many competitors have greater name recognition, more extensive collaborative relationships or the ability to leverage a broader vaccine
portfolio. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize vaccines that are safer,
more effective, more convenient, less expensive or with a more favorable label than any vaccine candidates that we may develop.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a result of these factors, our competitors
may obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine
candidates. Our competitors may also develop vaccines that are safer, more effective, more widely accepted or less expensive than ours,
and may also be more successful than we are in manufacturing and marketing their products. These advantages could render our vaccine candidates
obsolete or non-competitive before we can recover the costs of such vaccine candidates&rsquo; development and commercialization.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Mergers and acquisitions in the pharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and
early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established
companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel,
establishing clinical trial sites and subject enrollment for clinical trials, as well as in acquiring technologies complementary to, or
necessary for, our programs.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Product liability lawsuits against us could cause us to incur
substantial liabilities and to limit commercialization of any products that we may develop.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We face an inherent risk of product liability
exposure related to the testing of our current product candidates or future product candidates in human clinical trials and will face
an even greater risk if we commercially sell any products that we may develop. Product liability claims may be brought against us by subjects
enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product. If we cannot successfully
defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial liabilities. Regardless
of merit or eventual outcome, liability claims may result in:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">decreased demand for any product candidates or products that we may develop;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">termination of clinical trial sites or entire clinical trial programs;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">injury to our reputation and significant negative media attention;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">withdrawal of clinical trial participants;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">significant costs to defend the related litigation;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">substantial monetary awards to trial subjects or patients;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">loss of revenue;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">diversion of management and scientific resources from our business operations; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the inability to commercialize any products that we may develop.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to engaging in future clinical trials, we
intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate
to provide us with insurance coverage for foreseeable risks; however, we may be unable to obtain such coverage at a reasonable cost, if
at all. If we are able to obtain product liability insurance, 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 and such insurance may not be adequate to cover all liabilities that we
may incur. Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain
regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability
insurance for any products that receive regulatory approval. Large judgments have been awarded in class&nbsp;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.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may engage in acquisitions that could disrupt our business,
cause dilution to our stockholders or reduce our financial resources.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the future, we may enter into transactions
to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions
on favorable terms, or at all. Any acquisitions we make may fail to strengthen our competitive position and these transactions may be
viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or
other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.
We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
into our existing business in an effective, timely and non-disruptive manner. Acquisitions may also divert management attention from&nbsp;day-to-day
responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing
or size of future acquisitions or the effect that any such transactions might have on our operating results.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Security threats to our information technology infrastructure
and/or our physical buildings could expose us to liability and damage our reputation and business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is essential to our business strategy that
our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners
to be secure. Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security
threats. We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products
and services, misappropriate our or our customers&rsquo; and partners&rsquo; proprietary information, which may include personally identifiable
information, or cause interruptions of our internal systems and services. Despite security measures, we also cannot guarantee security
of our physical buildings. Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network
infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that are affected,
and expose us to financial liability.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, there are a number of state, federal
and international laws protecting the privacy and security of health information and personal data. For example, the Health Insurance
Portability and Accountability Act&nbsp;of&nbsp;1996, or HIPAA, imposes limitations on the use and disclosure of an individual&rsquo;s
healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities,
and also grants individuals rights with respect to their health information. HIPAA also imposes compliance obligations and corresponding
penalties&nbsp;for&nbsp;non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.
As part of the American Recovery and Reinvestment Act&nbsp;of&nbsp;2009, or ARRA, the privacy and security provisions of HIPAA were amended.
ARRA also made significant increases in the penalties for improper use or disclosure of an individual&rsquo;s health information under
HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently by the final omnibus rule adopted
in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been inappropriately
accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national
media. Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance
with encryption or other standards developed by the U.S.&nbsp;Department of Health and Human Services. Most states have laws requiring
notification of affected individuals and/or state regulators in the event of a breach of personal information, which is a broader class
of information than the health information protected by HIPAA.&nbsp;Many state laws impose significant data security requirements, such
as encryption or mandatory contractual terms, to ensure ongoing protection of personal information. Activities outside of the U.S.&nbsp;implicate
local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement&nbsp;for&nbsp;non-compliance.&nbsp;We&nbsp;may
be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws,
to protect against security breaches and hackers or to alleviate problems caused by such breaches.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will need to grow the size of our organization in the future,
and we may experience difficulties in managing this growth.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">As of November 14, 2022, we had 5 full-time and
8 subcontracted employees. We will need to grow the size of our organization in order to support our continued development and
potential commercialization of our product candidates. As our development and commercialization plans and strategies continue to
develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial and other resources may
increase. Our management, personnel and systems currently in place may not be adequate to support this future growth. Future growth
would impose significant added responsibilities on members of management, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">managing our clinical trials effectively;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">identifying, recruiting, maintaining, motivating and integrating additional employees;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>improving our managerial, development, operational, information technology, and finance systems; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">expanding our facilities.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our operations expand, we will also need to
manage additional relationships with various strategic partners, suppliers and other third parties. Our future financial performance and
our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future
growth effectively, as well as our ability to develop a sales and marketing force when appropriate. To that end, we must be able to manage
our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,
research and development, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks
could prevent us from successfully growing our company.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our future success depends on our ability to retain our executive
officers and to attract, retain and motivate qualified personnel.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are highly dependent upon our personnel, including
Joseph Hernandez, our Chief Executive Officer and members of our board of directors. The loss of Mr.&nbsp;Hernandez&rsquo;s services could
impede the achievement of our research, development and commercialization objectives. We have not obtained, do not own, nor are we the
beneficiary of, key-person&nbsp;life insurance. Our future growth and success depend on our ability to recruit, retain, manage and motivate
our employees. The loss of any member of our senior management team or the inability to hire or retain experienced management personnel
could compromise our ability to execute our business plan and harm our operating results. Because of the specialized scientific and managerial
nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.
The competition for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract
and retain qualified personnel necessary for the development of our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Chief Executive Officer, Joseph Hernandez, and our Chief
Financial Officer, Jon Garfield, also hold certain management positions and directorships of other companies and may allocate their time
to such other businesses, thereby causing conflicts of interest in their determination as to how much time to devote to our affairs. This
could have a negative impact on our ability to implement our plan of operation.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Chief Executive Officer, Joseph Hernandez
is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest
in allocating his time between our operations and his other businesses. Pursuant to Mr.&nbsp;Hernandez&rsquo;s employment agreement, Mr.&nbsp;Hernandez
shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business activities.
Subject to our Board&rsquo;s prior approval, Mr.&nbsp;Hernandez may serve as an officer, stakeholder, or member of the board of directors
or advisory board (or the equivalent in the case of a non-corporate entity) of non-competing for-profit businesses and charitable organizations,
provided, however, that such activities do not materially interfere, individually or in the aggregate, with the performance of his duties
and responsibilities to Blue Water Vaccines Inc. Accordingly, although Mr.&nbsp;Hernandez&rsquo;s primary occupation is his service to
Blue Water Vaccines Inc., he also holds certain management positions and directorships of other companies, and may allocate his time to
such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, our Chief Financial Officer, Jon
Garfield, is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict
of interest in allocating his time between our operations and his other businesses. Pursuant to Mr.&nbsp;Garfield&rsquo;s employment agreement,
Mr.&nbsp;Garfield shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business
activities, subject to the restrictions imposed on Mr.&nbsp;Hernandez as described above. Accordingly, Mr.&nbsp;Garfield holds certain
management positions and directorships of other companies, and may allocate his time to such other businesses, thereby causing conflicts
of interest in his determination as to how much time to devote to our affairs</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Each of Messrs. Hernandez and Garfield may also
have competitive fiduciary obligations and pecuniary interests relating to their other business ventures that conflict with our interests.
Each of Messrs. Hernandez and Garfield&rsquo;s employment agreement contains certain restrictive covenants while they are employed at
Blue Water Vaccines Inc. These restrictive covenants, generally, restrict Messrs. Hernandez and Garfield from engaging in any other business
or occupation that (x)&nbsp;conflicts with the interests of the Company, (y)&nbsp;interferes with the proper and efficient performance
of his duties for the Company, or (z)&nbsp;interferes with his exercise of judgment in the Company&rsquo;s best interests. Messrs. Hernandez
and Garfield are further subject to general restrictions regarding the solicitation of employees, certain customers, as well as the use
or disclosure of any confidential information, of the business of Blue Water Vaccines Inc. Notwithstanding the foregoing, to the extent
that these additional activities may have a conflict between their interests and ours, this could have a negative impact on our ability
to implement our plan of operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Certain significant personnel may allocate their time to other
businesses, which may cause conflicts of interest in their determination as to how much time to devote to our affairs and potentially
competitive fiduciary and pecuniary interests that conflict with our interests.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our executive officers are supported by Ronald
Cobb, Brian Price and Andrew Skibo, who provide valuable technical and strategic capabilities to us. They are not currently required to
commit their full time to our affairs. As such, they may allocate their time to other businesses. From time to time, those other commitments
may limit the nature of services that Messrs. Cobb, Price and Skibo provide to our Company, for instance, where such activities may involve
overlapping industries and products. If these individuals&rsquo; other business affairs require them to devote substantial amounts of
time to such affairs in excess of their current commitment levels, it could limit their ability to devote time or resources to our affairs,
which may have a negative impact on our ability to complete our plan of operations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Members of our management team and board of directors have significant
experience as founders, board members, officers or executives of other companies. As a result, certain of those persons have been and
may become involved in proceedings, investigations and litigation relating to the business affairs of the companies with which they were,
are, or may in the future be, affiliated. This may have an adverse effect on us, could damage our reputation and business.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">During the course of their careers, members of
our management team and board of directors have had significant experience as founders, board members, officers or executives of other
companies. As a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become,
involved in litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered
into by such companies. Any such litigation, investigations or other proceedings may divert our management team&rsquo;s and board&rsquo;s
attention and resources away from our affairs and may negatively affect our reputation and our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Inadequate funding for the FDA, the SEC and other government
agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being
developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which
the operation of our business may rely, which could negatively impact our business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The 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, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
in recent&nbsp;years as a result. In addition, government funding of the SEC and other government agencies on which our operations may
rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and
unpredictable.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Disruptions at the FDA and other agencies may
also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect
our business. For example, over the last several&nbsp;years, including beginning on December&nbsp;22, 2018, the U.S.&nbsp;government has
shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other
government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability
of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further,
in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary
capital in order to properly capitalize and continue our operations.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be adversely affected by natural disasters, pandemics
and other catastrophic events, and by man-made problems such as terrorism and acts of war, that could disrupt our business operations
and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"> If a disaster, power outage or other event occurred that prevented us from using all or a
significant portion of our headquarters, that damaged critical infrastructure, such as enterprise financial systems, manufacturing resource
planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for
us to continue our business for a substantial period of time. Our contract manufacturers&rsquo; and suppliers&rsquo; facilities are located
in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes, fires, explosions or large-scale
accidents or power outages, and other public health emergencies could severely disrupt our operations and have a material adverse effect
on our business, financial condition, operating results and prospects. For example, the recent COVID-19 pandemic may cause significant
disruption to our business operations, the operations of our third-party contractors and suppliers and the operations of our clinical
trials, including as a result of significant restrictions or bans on travel into and within the geographic areas in which our manufacturers
product our product candidates or where we conduct our clinical trials. A public health emergency could also affect the operations of
the FDA and other regulatory or public health authorities, resulting in delays to meetings related to planned or completed clinical trials
and ultimately of reviews and approvals of our product candidates. Such disruption could impede, delay, limit or prevent our employees
and third-party contractors from beginning or continuing research and development or clinical trial-related activities, which may impede,
delay, limit or prevent initiation or completion of our ongoing clinical trials and preclinical research and ultimately lead to the delay
or denial of regulatory approval of our product candidates, which could seriously harm our operations and financial condition.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our employees, independent contractors, principal investigators,
consultants, vendors and clinical research organizations, or CROs, may engage in misconduct or other improper activities, including noncompliance
with regulatory standards and requirements.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exposed to the risk that our employees,
independent contractors, principal investigators, consultants, vendors and CROs 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 foreign regulatory authorities;
manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; 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 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 comply 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. If any such actions are instituted against us, we may
have to terminate employees or others involved and the impact of such termination can result in our experiencing delays and additional
costs associated with replacing the services being provided. If we are not successful in defending ourselves or asserting our rights,
those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,
damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment,
contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could
adversely affect our ability to operate our business and our operating results.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Macroeconomic pressures in the markets in which we operate, including,
but not limited to, the effect of the COVID-19 pandemic and the current conflict between Ukraine and Russia may alter the ways in which
we conduct our business operations and manage our financial capacities.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To varying degrees, the ways in which we conduct
our business operations and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly
involved in or providing services related to the drug and biological product development. For example, real GDP growth, business and investor
confidence, the COVID-19 pandemic, the conflict between Ukraine and Russia, inflation, employment levels, oil prices, interest rates,
tax rates, availability of consumer and business financing, housing market conditions, foreign currency exchange rate fluctuations, costs
for items such as fuel and food and other macroeconomic trends can adversely affect not only our decisions and ability to engage in research
and development and clinical trials, but also those of our management, employees, third-party contractors, manufacturers and suppliers,
competitors, stockholders and regulatory authorities. In addition, geopolitical issues around the world and how our markets are positioned
can also impact the macroeconomic conditions and could have a material adverse impact on our financial results.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Economic uncertainty may adversely affect our access to capital,
cost of capital and ability to execute our business plan as scheduled.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Generally, worldwide economic conditions remain
uncertain. Access to capital markets is critical to our ability to operate. Traditionally, biotechnology companies have funded their research
and development expenditures through raising capital in the equity markets. Declines and uncertainties in these markets in the past have
severely restricted raising new capital and have affected companies&rsquo; ability to continue to expand or fund existing research and
development efforts. We require significant capital for research and development for our vaccine candidates and clinical trials. The general
economic and capital market conditions, both in the U.S.&nbsp;and worldwide, have been volatile in the past and at times have adversely
affected our access to capital and increased the cost of capital. There is no certainty that the capital and credit markets will be available
to raise additional capital on favorable terms. If economic conditions become worse, our future cost of equity or debt capital and access
to the capital markets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our
ability to execute our business plan as scheduled would be compromised. Moreover, we rely and intend to rely on third-parties, including
clinical research organizations, contract manufacturing organizations and other important vendors and consultants. Global economic conditions
may result in a disruption or delay in the performance of our third-party contractors and suppliers. If such third-parties are unable
to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.<B>&nbsp;</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Our Intellectual Property</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>It is difficult and costly to protect our proprietary rights,
and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could
compete against us more directly, which would harm our business, possibly materially.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our commercial success will depend in part on
obtaining and maintaining patent protection and trade secret protection of our current product candidates and future product candidates,
the processes used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party&nbsp;challenges.
Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent upon
the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The patent positions of biotechnology and pharmaceutical
companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S.&nbsp;or in foreign
jurisdictions outside of the U.S.&nbsp;Changes in either the patent laws or interpretations of patent laws in the U.S.&nbsp;and other
countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be enforced
in the patents that may be issued from the applications we currently license or may in the future own or license from third parties. Further,
if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates
or technology could be adversely affected.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Others may file patent applications covering products
and technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent
application owned by a third party will not have priority over patent applications filed or in-licensed&nbsp;by us, or that we or our
licensors will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings
before U.S.&nbsp;or non-U.S.&nbsp;patent offices. Such proceedings are also expensive and time consuming.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The degree of future protection for our proprietary
rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
or keep our competitive advantage. For example:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>others may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the patents of others may have an adverse effect on our business.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are dependent on licensed intellectual property. If we were
to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates,
if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product
candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license
rights that are important to our business.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not currently own any patents, and we are
heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important to our
business and we may need or choose to enter into additional license agreements in the future. Our existing license agreements impose,
and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations,
payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, or we
are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products
covered by the license. Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to
abide by the terms of the license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable
to enter into necessary licenses on acceptable terms.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Licensing of intellectual property is of critical
importance to our business and involves complex legal, business and scientific issues. Disputes may arise between us and our licensors
regarding intellectual property subject to a license agreement, including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the scope of rights granted under the license agreement and other interpretation-related issues;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">our right to sublicense patent and other rights to third parties;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">our obligation to pursue or license others to pursue development of indications we are not currently pursuing;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">our right to transfer or assign the license; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">the effects of termination.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If disputes over intellectual property that we
have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully
develop and commercialize the affected product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have entered into several licenses to support
our various programs. Termination of any of these license agreements would have a material adverse impact on our ability to develop and
commercialize derived products under each respective agreement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may enter into additional licenses to third-party
intellectual property that are necessary or useful to our business. Our current licenses and any future licenses that we may enter into
impose various royalty payment, milestone, and other obligations on us. Under some license agreements, we may not control prosecution
of the licensed intellectual property, or may not have the first right to enforce the intellectual property. In those cases, we may not
be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance
fees. If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have
breached our license agreement, and may accordingly seek to terminate our license. Termination of any of our current or future licenses
could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to
develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business
prospects. Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual
property and information related to the product candidate being developed under the license, such as regulatory information.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The agreements under which we license intellectual
property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple
interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope
of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations
under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations
and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current
licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product
candidates</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, if our licensors fail to abide by
the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are
found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.
Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject
to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor&rsquo;s rights.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similarly, if we are unable to successfully obtain
rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have
to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and
investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results
of operations and prospects could suffer.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Some of the intellectual property covered by our licenses concerns
patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications
will result in granted patents, nor can we predict how long it will take for such patents to be granted.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of intellectual property covered by our licenses
concerns certain, specified patent rights (including patent applications, provisional patent applications and PCT patent applications).
While in some instances, the licensors have agreed to assume responsibility for the preparation, filing, prosecution and maintenance of
patent applications covered by the licensed patent rights, we cannot be certain as to when or if final patents will be issued for those
patent applications covered by the licensed patent rights. However, the licensors may not successfully prosecute certain patent applications,
the prosecution of which they control, under which we are only a licensee and on which our business substantially depends. Even if patents
issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability
challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may
fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, it is possible that the licensed pending
patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide
a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.
Further, it is possible that, for any of the patents that may be granted in the future, others will design around the licensed patent
rights or identify methods for preventing or treating infectious diseases that do not concern the rights covered by our licenses. Further,
we cannot assure investors that other parties will not challenge any patents granted to the licensors or that courts or regulatory agencies
will hold licensor&rsquo;s patents to be valid or enforceable. We cannot guarantee investors that, if required to defend the covered patents,
we will have the funds to or be successful in defending challenges made against the licensed patents and patent applications. Any successful
third-party challenge to the licensed patents could result in the unenforceability or invalidity of such patents, or to such patents being
interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological or competitive
advantage over our competitors may be diminished because of these uncertainties.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if patents are issued based on patent applications to which
we have been granted a license, because the patent positions of pharmaceutical and biotechnology products are complex and uncertain, we
cannot predict the scope and extent of patent protection for our product candidates.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any patents that may be issued based on patent
applications that we have been granted licenses to will not ensure sufficient protection with respect to our activities for a number of
reasons, including without limitation the following:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>any issued patents may not be broad or strong enough to prevent competition from other vaccine products including identical or similar products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>if patents are not issued or if issued patents expire, there would be no protections against competitors making generic equivalents;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>there may be other patents existing, now or in the future, in the patent landscape for our product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>if patents that we have been granted licenses to are challenged, a court could determine that they are not valid or enforceable;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a court could determine that a competitor&rsquo;s technology or product does not infringe patents that we have been granted licenses to;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>patents to which we have been granted licenses could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>if we encounter delays in our development or clinical trials, the period of time during which we could market our products under patent protection would be reduced.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Periodic maintenance fees on any issued patent
are due to be paid to the United&nbsp;States Patent and Trademark Office (USPTO) and foreign Intellectual Property Offices in several
stages over the term of the patent. Maintenance fees are also due for pending patent applications in some countries. The USPTO and various
foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means
in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent
or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that
could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to office actions
within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our
competitors might be able to enter the market, which would have a material adverse effect on our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The life of patent protection is limited, and third parties could
develop and commercialize products and technologies similar or identical to ours and compete directly with us after the patent licensed
to us expires, which could materially and adversely affect our ability to commercialize our products and technologies.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The life of a patent and the protection it affords
is limited. For example, in the United&nbsp;States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
20&nbsp;years from its earliest U.S.&nbsp;non-provisional filing date. In Europe, the expiration of an invention patent is 20&nbsp;years
from its filing date. Even if we successfully obtain patent protection for an approved vaccine candidate, it may face competition from
biosimilar medications. Manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying
our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual
property rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materially
adversely affect any potential sales of that product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Given the amount of time required for the development,
testing and regulatory review of new vaccine candidates, patents protecting such vaccine candidates might expire before or shortly after
such vaccine candidates are commercialized. As a result, the patents and patent applications licensed to us may not provide us with sufficient
rights to exclude others from commercializing products similar or identical to ours. Even if we believe that the patents involved are
eligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including the
FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions
are available, and such authorities may refuse to grant extensions to such patents, or may grant more limited extensions than requested.
For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop,
one or more of the U.S.&nbsp;patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition
and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of
up to five&nbsp;years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend
the remaining term of a patent beyond a total of 14&nbsp;years from the date of product approval, only one patent may be extended and
only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may
not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process,
failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy
applicable requirements.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, the applicable time period or the scope
of patent protection afforded could be less than requested. If we are unable to obtain patent term extension or term of any such extension
is less than requested, our competitors may obtain approval of competing products following our patent expiration, and our business could
be harmed. Changes in either the patent laws or interpretation of the patent laws in the United&nbsp;States and other countries may diminish
the value of our patents or narrow the scope of our patent protection.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The patents and pending patent applications licensed
to us for our product candidates are expected to expire on various dates. Upon the expiration, we will not be able to assert such licensed
patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations
and prospects.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may need to license intellectual property from third parties,
and such licenses may not be available or may not be available on commercially reasonable terms or at all.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There may be intellectual property rights existing
now, or in the future, relevant to our product candidates that we seek to commercialize or develop, if any, that may affect our ability
to commercialize such product candidates. Although the Company is not aware of any such intellectual property rights, a third-party may
hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product
candidates. Even if all our main product candidates are covered by patents, it may be necessary for us to use the patented or proprietary
technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these
third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable
contractual terms. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates,
or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical
or commercial basis. If we are unable to do so, our business could be harmed.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The licensing or acquisition of third-party intellectual
property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party
intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage
over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies
that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third
party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable
to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights
we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on
our business, financial condition, results of operations, and prospects.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may infringe the intellectual property rights of others, which
may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product
candidates.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our success will depend in part on our ability
to operate without infringing the proprietary rights of third parties. We are not aware of any third party proprietary rights that our
planned products will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages
of development. We thus cannot guarantee that our product candidates, or manufacture or use of our product candidates, will not infringe
third-party&nbsp;patents. Furthermore, a third party may claim that we are using inventions covered by the third party&rsquo;s patent
rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.
These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel.
Some of these third parties may be better capitalized and have more resources than us. There is a risk that a court would decide that
we are infringing the third party&rsquo;s patents and would order us to stop the activities covered by the patents. In that event, we
may not have a viable way around the patent and may need to halt commercialization of our product candidates. In addition, there is a
risk that a court will order us to pay the other party damages for having violated the other party&rsquo;s patents. In addition, we may
be obligated to indemnify our licensors and collaborators against certain intellectual property infringement claims brought by third&nbsp;parties,
which could require us to expend additional resources. The pharmaceutical and biotechnology industries have produced a proliferation of
patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of
use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we are sued for patent infringement, we would
need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the
patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity
requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are
successful in these proceedings, we may incur substantial costs and diversion of management&rsquo;s time and attention in pursuing these
proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may
be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court.
Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.
In addition, if we do not obtain a license, develop or obtain non-infringing&nbsp;technology, fail to defend an infringement action successfully
or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product
candidates to market and be precluded from manufacturing or selling our product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of our competitors may be able to sustain
the costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because
they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation
could have a material adverse effect on our ability to raise the funds necessary to continue our operations.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may become involved in lawsuits to protect or enforce our
intellectual property, which could be expensive, time consuming and unsuccessful.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the possibility of litigation relating
to infringement claims asserted against it, we may become a party to other patent litigation and other proceedings, including <I>inter
partes</I> review proceedings, post-grant review proceedings, derivation proceedings declared by the USPTO and similar proceedings in
foreign countries, regarding intellectual property rights with respect to our current or future technologies or product candidates or
products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our
competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially
greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties resulting
from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Competitors may infringe or otherwise violate
our intellectual property, including patents that may issue to or be licensed by us. As a result, we may be required to file claims in
an effort to stop third-party infringement or unauthorized use. Any such claims could provoke these parties to assert counterclaims against
us, including claims alleging that we infringe their patents or other intellectual property rights, and/or that any of our intellectual
property, including licensed intellectual property, is invalid and/or unenforceable. This can be prohibitively expensive, particularly
for a company of our size, and time-consuming, and even if we are successful, any award of monetary damages or other remedy we may receive
may not be commercially valuable. In addition, in an infringement proceeding, a court may decide that our asserted intellectual property
is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our intellectual
property does not cover its technology. An adverse determination in any litigation or defense proceedings could put our intellectual property
at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If the breadth or strength of our patent or other
intellectual property rights is compromised or threatened, it could allow third parties to exploit and, in particular, commercialize our
technology or products or result in our inability to exploit and/or commercialize our technology and products without infringing third-party
intellectual property rights. Further, third parties may be dissuaded from collaborating with us.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Interference or derivation proceedings brought
by the USPTO or its foreign counterparts may be necessary to determine the priority of inventions with respect to our patent applications,
and we may also become involved in other proceedings, such as re-examination proceedings, before the USPTO or its foreign counterparts.
Due to the substantial competition in the pharmaceutical space, the number of such proceedings may increase. This could delay the prosecution
of our pending patent applications or impact the validity and enforceability of any future patents that we may obtain. In addition, any
such litigation, submission or proceeding may be resolved adversely to us and, even if successful, may result in substantial costs and
distraction to our management.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we are not able to adequately prevent disclosure of trade
secrets and other proprietary information, the value of our technology and product could be significantly diminished.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We also rely on trade secrets to protect our proprietary
technologies, 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. For example, the FDA, as part
of its transparency initiative, is currently considering whether to make additional information publicly available on a routine basis,
including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time
how the FDA&rsquo;s disclosure policies may change in the future, if at all. Costly and time-consuming&nbsp;litigation could be necessary
to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely
affect our competitive business position.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be subject to claims that our employees or consultants
have wrongfully used or disclosed alleged trade secrets.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As is common in the biotechnology and pharmaceutical
industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors
or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how&nbsp;of
others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used
or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these
claims. If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property
rights or personnel, which could adversely impact our business. Even if we are successful in defending against these claims, litigation
could result in substantial costs and be a distraction to management.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our intellectual property may not be sufficient to protect our
product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may be subject to competition despite the existence
of intellectual property we license or may in the future own. We can give no assurances that our intellectual property claims will be
sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive products.
The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and
financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third
parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization
of our product candidates or future product candidates.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may elect to sue a third party, or otherwise
make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or
other intellectual property rights that we either own or license from a third party. If we do not prevail in enforcing our intellectual
property rights in this type of litigation, we may be subject to:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>paying monetary damages related to the legal expenses of the third party;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A third party may also challenge the validity,
enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope
or claims of or invalidate patents that are integral to our product candidates in the future. There can be no assurance that we will be
able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and
the high costs associated with intellectual property litigation, amongst other factors.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Intellectual property rights may be less extensive
and enforcement more difficult in jurisdictions outside of the U.S.&nbsp;Therefore, we may not be able to protect our intellectual property
and third parties may be able to market competitive products that may use some or all of our intellectual property.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Changes to patent law, including the Leahy-Smith&nbsp;America
Invests Act&nbsp;of&nbsp;2011 and the Patent Reform Act&nbsp;of&nbsp;2009 and other future article of legislation, may substantially change
the regulations and procedures surrounding patent applications, issuance of patents and prosecution of patents. We can give no assurances
that the patents of our licensor can be defended or will protect us against future intellectual property challenges, particularly as they
pertain to changes in patent law and future patent law interpretations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Healthcare Compliance and Other Regulations</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we fail to comply with healthcare regulations, we could face
substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be
adversely affected.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We could be subject to healthcare fraud and abuse
laws and patient privacy laws of both the federal government and the states in which we conduct our business. The laws include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the federal healthcare program anti-kickback law, which prohibits, among other things, persons from 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;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>HIPAA which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products&nbsp;for&nbsp;off-label&nbsp;use&nbsp;and regulates the distribution of drug samples; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state 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 federal laws, thus complicating compliance efforts.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our operations are found to be in violation
of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and
criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment
or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Although compliance
programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal
expenses and divert management&rsquo;s attention from the operation of our business. Moreover, achieving and sustaining compliance with
applicable federal and state privacy, security and fraud laws may prove costly.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Healthcare reform in the United&nbsp;States has been implemented
in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry.
Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, there have been, and
continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future
results of pharmaceutical manufactures&rsquo; operations. In particular, there have been and continue to be a number of initiatives at
the federal and state levels that seek to reduce healthcare costs. For example, the Affordable Care Act, or the ACA, which was originally
enacted in March&nbsp;2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both
governmental and private insurers. Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry
are the following:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>implementation of the federal physician payment transparency requirements, sometimes referred to as the &ldquo;Physician Payments Sunshine Act&rdquo;;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a licensure framework for&nbsp;follow-on&nbsp;biologic products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>establishment of a Center for Medicare Innovation at the Centers for Medicare&nbsp;&amp; Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>extension of manufacturers&rsquo; Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers&rsquo; Medicaid rebate liability;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
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    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a new Medicare Part&nbsp;D coverage gap discount program, in which manufacturers must agree to offer 50%&nbsp;point-of-sale&nbsp;discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer&rsquo;s outpatient drugs to be covered under Medicare Part&nbsp;D; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>expansion of the entities eligible for discounts under the Public Health program.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of the provisions of the ACA have yet to
be implemented, and there have been legal and political challenges to certain aspects of the ACA.&nbsp;The former Trump administration
issued certain executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA.&nbsp;Concurrently,
Congress considered legislation that would repeal or repeal and replace all or part of the ACA.&nbsp;While Congress has not passed repeal
legislation, the Tax Cuts and Jobs Act&nbsp;of&nbsp;2017 included a provision repealing, effective January&nbsp;1, 2019, the&nbsp;tax-based&nbsp;shared
responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a
year that is commonly referred to as the &ldquo;individual mandate.&rdquo; Congress may consider other legislation to repeal or replace
elements of the ACA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of the details regarding the implementation
of the ACA are yet to be determined, and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains
unclear. In particular, there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.&nbsp;This uncertainty
is heightened by President Biden&rsquo;s January&nbsp;28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act,
which indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump
administration. In August 2022, President Biden signed the Inflation Reduction Act, which extended enhanced subsidies, passed
as part of the American Rescue Plan Act in 2021, and prevented insurance companies from imposing significant increases in healthcare premiums
for low income exchange customers through 2025. In addition, under this legislation, Medicare will have the ability to negotiate drug
prices for a select list of pharmaceuticals in Medicare Part D drugs, with the list of included drugs expected to increase over the coming
years and incorporate drugs in Medicare Parts B and D.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA has issued several guidance documents,
but no implementing regulations, on biosimilars. A number of biosimilar applications have been approved over the past few&nbsp;years.
The regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical
manufacturers conduct their business and may require changes to current strategies. A biosimilar is a biological product that is highly
similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically
meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Individual states have become increasingly aggressive
in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price
or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency
measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by
third-party payors or other restrictions could harm a pharmaceutical manufacturer&rsquo;s business, results of operations, financial condition
and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could
reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical manufacturer&rsquo;s
business, results of operations, financial condition and prospects.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is also possible that President Biden will
further reform the ACA and other federal programs in a manner that may impact our operations. For example, the Biden administration has
indicated that a goal of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible
and affordable. The potential increase in patients covered by government funded insurance may impact our pricing. Further, it is possible
that the Biden administration may further increase the scrutiny on drug pricing, <FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">including a recent provision of the
2023 Inflation Reduction Act, allowing Medicare to negotiate pharmaceutical prices directly with drug manufacturers</FONT>.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, given recent federal and state government
initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely continue
to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. For
example, there have been several recent U.S.&nbsp;congressional inquiries and proposed federal and proposed and enacted state legislation
designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient
programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. Further,
in July&nbsp;2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug
products including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts
for plans, pharmacies, and pharmaceutical benefit managers. No assurance can be given whether these orders will remain in effect under
the&nbsp;Biden&nbsp;administration.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">While no one can predict the full outcome of any
such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure
to reduce prescription drug prices. This could harm a pharmaceutical manufacturer&rsquo;s ability to generate revenue. Increases in importation
or&nbsp;re-importation&nbsp;of pharmaceutical products from foreign countries into the United&nbsp;States could put competitive pressure
on a pharmaceutical manufacturer&rsquo;s ability to profitably price products, which, in turn, could adversely affect business, results
of operations, financial condition and prospects. A pharmaceutical manufacturer might elect not to seek approval for or market products
in foreign jurisdictions in order to minimize the risk of&nbsp;re-importation,&nbsp;which could also reduce the revenue generated from
product sales. It is also possible that other legislative proposals having similar effects will be adopted.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Furthermore, regulatory authorities&rsquo; assessment
of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as
the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership. We cannot
be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. For example,
average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding
levels and statutory, regulatory and policy changes.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our employees may engage in misconduct or other
improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us
and harm our reputation.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exposed to the risk of employee fraud or
other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory
authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards
we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established
and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities
to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result
in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the
precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in
protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
or regulations. 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 significant impact on our business and results of operations, including the imposition of significant civil,
criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare
and Medicaid, and integrity oversight and reporting obligations.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may rely on government funding and collaboration with government
entities for our vaccine development, which adds uncertainty to our research and development efforts and may impose requirements that
increase the costs of development, commercialization and production of any programs developed under those government-funded programs.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because we anticipate the resources necessary to develop our vaccine
product candidates will be substantial, we may explore funding and development collaboration opportunities with the U.S.&nbsp;government
and its agencies. For example, we may apply for certain grant funding from BARDA, the NIH or other government agencies to further the
research, development, manufacture, testing, and regulatory approval of our vaccine product candidates. We have no control or input over
whether an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide
investors with any assurances that we will receive such funding.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Contracts and grants funded by the U.S.&nbsp;government
and its agencies, contain provisions that reflect the government&rsquo;s substantial rights and remedies, many of which are not typically
found in commercial contracts, including powers of the government to:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>reduce or modify the government&rsquo;s obligations under such agreements without the consent of the other party;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>claim rights, including Intellectual Property rights, in products and data developed under such agreements;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>audit contract-related costs and fees, including allocated indirect costs;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>impose U.S.&nbsp;manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>suspend or debar the contractor or grantee from doing future business with the government;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>control and potentially prohibit the export of products;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>limit the government&rsquo;s financial liability to amounts appropriated by the U.S.&nbsp;Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we received such grants or agreements, we may
not have the right to prohibit the U.S.&nbsp;government from using certain technologies developed by us, and we may not be able to prohibit
third-parties, including our competitors, from using those technologies in providing products and services to the U.S.&nbsp;government.
Further, under such agreements we could be subject to obligations to and the rights of the U.S.&nbsp;government set forth in the Bayh-Dole
Act&nbsp;of&nbsp;1980, meaning the U.S.&nbsp;government may have rights in certain inventions developed under these government-funded
agreements, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
In addition, the U.S.&nbsp;government could have the right to require us to grant exclusive, partially exclusive, or nonexclusive licenses
to any of these inventions to a third party if it determines that: (i)&nbsp;adequate steps have not been taken to commercialize the invention;
(ii)&nbsp;government action is necessary to meet public health or safety needs; or (iii)&nbsp;government action is necessary to meet requirements
for public use under federal regulations, also referred to as &ldquo;march-in rights.&rdquo; Although the U.S.&nbsp;government&rsquo;s
historic restraint with respect to these rights indicates they are unlikely to be used, any exercise of the march-in rights could harm
our competitive position, business, financial condition, results of operations, and prospects. In the event we would be subject to the
U.S.&nbsp;government&rsquo;s exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S.&nbsp;government
in its sole discretion, which may be less than what we might be able to obtain in the open market.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the U.S.&nbsp;government requires
that any products embodying any invention generated through the use of U.S.&nbsp;government funding be manufactured substantially in the
United&nbsp;States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable
but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
substantially in the United&nbsp;States or that under the circumstances domestic manufacture is not commercially feasible. This preference
for U.S.&nbsp;manufacturers may limit our ability to contract with non-U.S.&nbsp;manufacturers for products covered by such intellectual
property.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Although we may need to comply with some of these
obligations, not all of the aforementioned obligations may be applicable to us unless and only to the extent that we receive a government
grant, contract or other agreement. However, as an organization, we are relatively new to government contracting and new to the regulatory
compliance obligations that such contracting entails. If we were to fail to maintain compliance with those obligations, we may be subject
to potential liability and to termination of our contracts, which may have a materially adverse effect on our ability to develop our vaccine
product candidates.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are subject to U.S.&nbsp;and certain foreign export and import
controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations.&nbsp;Compliance with these legal
standards could impair our ability to compete in domestic and international markets.&nbsp;We can face criminal liability and other serious
consequences for violations, which can harm our business.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are subject to export control and import laws
and regulations, including the U.S.&nbsp;Export Administration Regulations, U.S.&nbsp;Customs regulations, various economic and trade
sanctions regulations administered by the U.S.&nbsp;Treasury Department&rsquo;s Office of Foreign Assets Controls, the U.S.&nbsp;Foreign
Corrupt Practices Act&nbsp;of&nbsp;1977, as amended, the U.S.&nbsp;domestic bribery statute contained in 18 U.S.C. &sect; 201, the U.S.&nbsp;Travel
Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct
activities.&nbsp;Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other
collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value
to recipients in the public or private sector.&nbsp;We may engage third parties for clinical trials outside of the United&nbsp;States,
to sell our products abroad once we enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations,
and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated
hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents,
contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations
of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of
export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Owning our Common Stock</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The market price of our common stock has been extremely volatile
and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their
investment.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The market price of our common stock may be highly
volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>whether we achieve our anticipated corporate objectives;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>actual or anticipated fluctuations in our financial condition and operating results;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: justify">changes in financial or operational estimates or projections;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the development status of our product candidates and when our products receive regulatory approval;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>our execution of our sales and marketing, manufacturing and other aspects of our business plan;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>performance of third parties on whom we rely to manufacture our products, product components and product candidates, including their ability to comply with regulatory requirements;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>the results of our clinical studies and clinical trials;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>results of operations that vary from those of our competitors and the expectations of securities analysts and investors;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>our announcement of significant contracts, acquisitions or capital commitments;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>announcements by our competitors of competing products or other initiatives;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>announcements by third parties of significant claims or proceedings against us;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>regulatory and reimbursement developments in the United&nbsp;States and abroad;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>future sales of our common stock;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>product liability claims;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>healthcare reform measures in the United&nbsp;States;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>additions or departures of key personnel; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>general economic or political conditions in the United&nbsp;States or elsewhere.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">In addition, the stock market in general, and the
stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of the issuer. For example, on March 15, 2022 and August&nbsp;24, 2022,
the closing price of our common stock on Nasdaq was $67.90 and $3.25, respectively, and daily trading volume on these days was approximately
12,500 and 1,273,055 shares, respectively. Additionally, our intraday trading prices have experienced extreme fluctuation. On February
22, 2022, the difference between our high and low trading price was $40.80. These broad market fluctuations may adversely affect the trading
price of our common stock. In particular, a proportion of our common stock may be traded by short sellers which may put pressure on the
supply and demand for our common stock, further influencing volatility in its market price. Additionally, these and other external factors
have caused and may continue to cause the market price and demand for our common stock to fluctuate, which may limit or prevent investors
from readily selling their shares of common stock and may otherwise negatively affect the liquidity of our common stock. While the market
price of our common stock may respond to developments regarding operating performance and prospects, expansion plans, developments regarding
our participation in direct contracting, the impacts of COVID-19, and developments regarding our industry, we believe that the extreme
volatility we experienced in recent periods reflects market and trading dynamics unrelated to our underlying business, our actual or expected
operating performance, our financial condition, or macro or industry fundamentals, and we do not know if these dynamics will continue
or how long they will last . Under these circumstances, we caution you against investing in our common stock, unless you are prepared
to incur the risk of losing all or a substantial portion of your investment.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be subject to securities litigation, which is expensive
and could divert our management&rsquo;s attention.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The market price of our securities may be volatile,
and in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class
action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
costs and divert our management&rsquo;s attention from other business concerns, which could seriously harm our business.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Amended and Restated Certificate of Incorporation requires,
to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers, other employees
or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in the State of Delaware
and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service of process on such
stockholder&rsquo;s counsel, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,
other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in
the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service
of process on such stockholder&rsquo;s counsel except any action (A)&nbsp;as to which the Court of Chancery in the State of Delaware determines
that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent
to the personal jurisdiction of the Court of Chancery within ten&nbsp;days following such determination), (B)&nbsp;which is vested in
the exclusive jurisdiction of a court or forum other than the Court of Chancery, (C)&nbsp;for which the Court of Chancery does not have
subject matter jurisdiction, or (D)&nbsp;any action arising under the Securities Act, as to which the Court of Chancery and the federal
district court for the District of Delaware shall have concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring
any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our Amended and
Restated Certificate of Incorporation. This choice of forum provision may make it more costly for a stockholder to bring a claim, and
it may also limit a stockholder&rsquo;s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any
of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders
cannot waive our compliance with federal securities laws and the rules and regulations thereunder. 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 harm our business,
operating results and financial condition.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law. Section&nbsp;27 of the
Exchange&nbsp;Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange&nbsp;Act
or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty
or liability created by the Exchange&nbsp;Act or any other claim for which the federal courts have exclusive jurisdiction. In addition,
our Amended and Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum,
the federal district courts of the United&nbsp;States of America shall, to the fullest extent permitted by law, be the exclusive forum
for the resolution of any complaint asserting a cause of action arising under the Securities Act&nbsp;of&nbsp;1933, as amended, or the
rules and regulations promulgated thereunder. We note, however, that there is uncertainty as to whether a court would enforce this provision
and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section&nbsp;22
of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability
created by the Securities Act or the rules and regulations thereunder.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>An active trading market for our common stock may not develop
or be sustained.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to the commencement of trading of our common
stock on February&nbsp;18, 2022, no public market for our common stock existed. Although our common stock is listed on The Nasdaq Capital
Market, an active trading market for our common stock may not develop, or if developed, be sustained. The lack of an active market may
impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable. The lack of an active
market may also reduce the fair value of your shares.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Further, an inactive market may also impair our
ability to raise capital by selling shares of our common stock may impair our ability to enter into strategic partnerships or acquire
companies or products by using our shares of common stock as consideration.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our principal stockholders and management own a significant percentage
of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to stockholders
for approval.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of November 9, 2022, our officers and directors,
together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 7,058,224
shares of our common stock, which in the aggregate represents approximately 45.6% of the outstanding shares of our common stock. As a
result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted
to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate
of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.
These actions may be taken even if they are opposed by other stockholders. This concentration of ownership may also have the effect of
delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could
prevent our stockholders from receiving a premium for their shares. Some of these persons or entities who make up our principal stockholders
may have interests different from yours.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>There can be no assurance that we will be able to comply with
the continued listing standards of Nasdaq.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our continued eligibility for listing on Nasdaq
depends on our ability to comply with Nasdaq&rsquo;s continued listing requirements. If Nasdaq delists the common stock from trading on
its exchange for failure to meet the listing standards, we and our stockholders could face significant material adverse consequences including:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a limited availability of market quotations for our securities;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a determination that our common stock is a &ldquo;penny stock,&rdquo; which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

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<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
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    <TD>a limited amount of analyst coverage; and</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in">&nbsp;</TD>
    <TD STYLE="width: 0.25in">&#9679;</TD>
    <TD>a decreased ability to issue additional securities or obtain additional financing in the future.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If our shares become subject to the penny stock rules, it would
become more difficult to trade our shares.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The SEC has adopted rules that regulate broker-dealer
practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00,
other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems,
provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system.
If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny
stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to
deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before
effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination
that the penny stock is a suitable investment for the purchaser and receive (i)&nbsp;the purchaser&rsquo;s written acknowledgment of the
receipt of a risk disclosure statement; (ii)&nbsp;a written agreement to transactions involving penny stocks; and (iii)&nbsp;a signed
and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity
in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Future sales of our shares by existing stockholders could cause
our stock price to decline.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we or our existing stockholders, directors
and officers sell, or indicate an intent to sell, substantial amounts of our common stock or securities convertible into our common stock
in the public market after contractual lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading
price of our common stock could decline significantly and could decline below the initial public offering price. We have outstanding 15,474,957
shares of common stock as of the date hereof, assuming no exercise of outstanding options or warrants, are or will be freely tradable,
without restriction, in the public market. If our existing stockholders sell substantial amounts of our common stock in the public market,
or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even
if there is no relationship between such sales and the performance of our business. We have previously registered 1,600,000 shares of
common stock under our equity compensation plans and will be registering an additional 1,000,000 pursuant to the registration statement
of which this prospectus forms a part. These shares can be freely sold in the public market upon issuance, subject to volume limitations
applicable to affiliates and lock-up agreements&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">After the lock-up agreements pertaining to our
initial public offering expire, an additional 8,826,365 shares will be eligible for sale in the public market. In addition, upon issuance,
the 1,412,411 shares subject to outstanding options under our stock option plan and the shares reserved for future issuance under our
stock option plan will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.
If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales
could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such
sales and the performance of our business.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are an &ldquo;emerging growth company&rdquo; and the reduced
disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are an &ldquo;emerging growth company,&rdquo;
as defined in the JOBS Act. We may remain an &ldquo;emerging growth company&rdquo; until as late as December&nbsp;31, 2027 (the fiscal
year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an &ldquo;emerging
growth company&rdquo; earlier under certain circumstances, including (1)&nbsp;if the market value of our common stock that is held by
nonaffiliates exceeds $700&nbsp;million as of any June&nbsp;30, in which case we would cease to be an &ldquo;emerging growth company&rdquo;
as of the following December&nbsp;31, or (2)&nbsp;if our gross revenue exceeds $1.235&nbsp;billion in any fiscal year. &ldquo;Emerging
growth companies&rdquo; may take advantage of certain exemptions from various reporting requirements that are applicable to other public
companies, including not being required to comply with the auditor attestation requirements of Section&nbsp;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. Investors could find our common stock less attractive because we may rely on these exemptions. If some investors
find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price
may be more volatile.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, Section&nbsp;102 of the JOBS Act
also provides that an &ldquo;emerging growth company&rdquo; can take advantage of the extended transition period provided in Section&nbsp;7(a)(2)(B)&nbsp;of
the Securities Act, for complying with new or revised accounting standards. An &ldquo;emerging growth company&rdquo; can therefore delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are subject to increased costs as a result of operating as
a public company, and our management is required to devote substantial time to new compliance initiatives.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a public company, we incur significant legal,
accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements.
The Sarbanes-Oxley Act&nbsp;of&nbsp;2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The
Nasdaq Capital Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including
requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.
Further, in July&nbsp;2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are
significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional
rules and regulations in these areas, such as &ldquo;say on pay&rdquo; and proxy access. Emerging growth companies may implement many
of these requirements over a longer period of up to five&nbsp;years from the pricing of their initial public offering. We intend to take
advantage of these extended transition periods but cannot guarantee that we will not be required to implement these requirements sooner
than budgeted or planned and thereby incur unexpected expenses. Stockholder activism, the current political environment and the current
high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which
may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.
Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company
reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines
prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote
additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant
legal and financial compliance costs and will make some activities more time-consuming and costly.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To comply with the requirements of being a public
company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting
or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control
over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure
that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Securities
Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive and financial officers.
Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial
reporting may be discovered in the future. Any failure to develop or maintain effective controls when we become subject to this requirement
could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation
reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic
reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results,
cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that
we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived
as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating
results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may
not be able to remain listed on Nasdaq.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The rules and regulations applicable to public
companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse
effect on our business, financial condition, and results of operations. The increased costs will decrease our net income and may require
us to reduce costs in other areas of our business or increase the prices of our products or services. For example, these rules and regulations
made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial
costs in the future to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we
may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain
qualified persons to serve on our board of directors, our board committees or as executive officers.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our management team has limited experience managing a public
company.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Most members of our management team have limited
experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws
pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company
subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of
securities analysts and investors. These new obligations and constituents require significant attention from our senior management and
could divert their attention away from the&nbsp;day-to-day management of our business, which could adversely affect our business, financial
condition and operating results.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we fail to maintain an effective system of internal controls,
we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our
business and operating results and cause the trading price of our stock to decline.</I></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Effective internal controls required under Section&nbsp;404
of the Sarbanes-Oxley Act, are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide
reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed. We have discovered, and may
in the future discover, areas of our internal controls that need improvement. We cannot be certain that the measures we have taken or
intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future. Any failure to
implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,
harm our business and operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also harm
our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the
trading price of our stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The trading market for our common stock depends,
in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts
may never publish research on us. If no or few securities or industry analysts commence coverage of us, the price for our common stock
could be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover
us downgrade our common stock or publish inaccurate or unfavorable research about our business, our stock price could decline. In addition,
if our operating results fail to meet the forecast of analysts, our stock price could decline. If one or more of these analysts cease
coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price
and trading volume to decline.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Amended and Restated Certificate of Incorporation and our
Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control,
which may cause our stock price to decline.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing such
a transaction would be beneficial to our stockholders. Our Amended and Restated Certificate of Incorporation authorizes us to issue up
to 10,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined
at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may
include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion
and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of
the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future
holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve
control by the present management.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

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

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Provisions of our Amended and Restated Certificate
of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals
or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such
provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Amended
and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: left">provide the board of directors with the ability to alter the bylaws without stockholder approval;</TD></TR>
  </TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: left">place limitations on the removal of directors;</TD></TR>
  </TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: left">establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and</TD></TR>
  </TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
    <TD STYLE="text-align: left">provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.</TD></TR>
  </TABLE>
<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These provisions, alone or together, could delay
or prevent hostile takeovers and changes in control or changes in our management.</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a Delaware corporation, we are also subject
to provisions of Delaware law, including Section&nbsp;203 of the Delaware General Corporation law, which prevents certain stockholders
holding more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of the holders
of at least two-thirds of our outstanding common stock not held by such stockholder.</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any provision of our Amended and Restated Certificate
of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing or deterring a change in control
could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the
price that some investors are willing to pay for our common stock.</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We do not anticipate paying any cash dividends on our common
stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the
foreseeable future.</I></B></P>

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

<P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have never declared or paid cash dividends
on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend
to retain all available funds and any future earnings to fund the development and growth of our business. In addition, and any future
loan arrangements we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our
common stock. As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of gain
for the foreseeable future.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0"><B><I>A possible &ldquo;short squeeze&rdquo; due to a sudden increase
in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.</I></B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin: 0pt 0; text-align: left">Investors may purchase our common stock to hedge
existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may
involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for
purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders
of our common stock. Those repurchases may in turn, dramatically increase the price of our common stock until investors with short exposure
are able to purchase additional common shares to cover their short position. This is often referred to as a &ldquo;short squeeze.&rdquo;
A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects
of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common
stock may decline.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_006"></A>SELLING STOCKHOLDERS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The following table sets
forth (a) the name and position or positions with the Company of each Selling Stockholder; (b) the aggregate of (i) the number of shares
of Common Stock held by each Selling Stockholder as of the date of this prospectus and (ii) the number of shares issuable upon exercise
of options granted to each Selling Stockholder under the 2019 Plan and the 2022 Plan that are being registered pursuant to this Registration
Statement for resale by each Selling Stockholder as of the date of this prospectus; (c) the number of shares of Common Stock issuable
upon exercise of options that each Selling Stockholder may offer for sale from time to time pursuant to this prospectus, whether or not
such Selling Stockholder has a present intention to do so; and (d) the number of shares of Common Stock to be beneficially owned by each
Selling Stockholder following the sale of all shares that may be so offered pursuant to this prospectus, assuming no other change in ownership
of Common Stock by such Selling Stockholder after the date of this prospectus. Unless otherwise indicated, beneficial ownership is direct
and the person indicated has sole voting and investment power.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
may, from time to time, resell all, a portion or none of the shares of our Common Stock covered by this reoffer prospectus.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Inclusion of an individual&rsquo;s
name in the table below does not constitute an admission that such individual is an &ldquo;affiliate&rdquo; of the Company.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom; background-color: white">
    <TD STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-size: 10pt"><B>Selling Stockholder</B></FONT></TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Principal Position with<BR>
the Company (1)</B></FONT></TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD COLSPAN="5" STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Shares Owned<BR>
Prior to Resale<BR>
(2)</B></FONT></TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number of Shares<BR>
Offered for Resale</B></FONT></TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD COLSPAN="6" STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Shares Beneficially Owned<BR>
After Resale</B></FONT></TD>
    <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Percent</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Percent</B></FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top; width: 23%"><FONT STYLE="font-size: 10pt">Joseph Hernandez</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 17%"><FONT STYLE="font-size: 10pt">Chairman and Chief Executive Officer</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">2,850,351</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">18.18</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">200,000</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">2,650,351</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">16.91</FONT></TD>
    <TD STYLE="vertical-align: bottom; width: 1%"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Erin Henderson </FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Chief Business Officer and Secretary </FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">241,028</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">1.54</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">216,276</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">24,752</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Jon Garfield</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Chief Financial Officer</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">100,000</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">100,000</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Kimberly Murphy</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Allan Shaw</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Former Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">James Sapirstein</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Michael Venerable</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Former Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Simon Tarsh</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,073</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,073</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Vuk Jeremi&cacute;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">3,610</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">3,610</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Brian Price</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">32,552</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">32,552</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">David Zarley</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">15,320</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">15,320</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: white">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">CincyTech Fund IV, LLC</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">851,988</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">5.49</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">45,920</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">806,068</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">5.19</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF">
    <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Sunetra Gupta</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Advisory Board Member</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">459,200</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">2.88</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">459,200</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom">&nbsp;</TD>
    <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">&mdash;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in; text-align: left">*</TD><TD STYLE="text-align: justify">Less than 1%.</TD>
</TR></TABLE>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in; text-align: justify">(1)</TD>
    <TD STYLE="text-align: justify">All positions described are with the Company, unless otherwise indicated.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">(2)</TD>
    <TD>The number of shares owned prior to resale by each Selling Stockholder shares of Common Stock owned on or about the date hereof by the Selling Stockholders and shares of common stock that are issued or to be issued, or which may be acquired upon the exercise of stock options issued or to be issued, or vesting of restricted stock awards issued or to be issued, pursuant to the 2019 Plan and the 2022 Plan.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The
Company may supplement this prospectus from time to time as required by the rules of the Commission to include certain information concerning
the security ownership of the Selling Stockholders or any new Selling Stockholders, the number of securities offered for resale and the
position, office or other material relationship which a Selling Stockholder has had within the past three years with the Company or any
of its predecessors or affiliates.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="a_007"></A>USE OF PROCEEDS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">We will not receive any proceeds
from the resale of our Common Stock by the Selling Stockholders pursuant to this prospectus. However, we will receive the exercise price
of any Common Stock issued to the Selling Stockholders upon cash exercise by them of their options. We would expect to use these proceeds,
if any, for general working capital purposes. We have agreed to pay the expenses of registration of these shares.</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: center; background-color: white"><B><A NAME="a_008"></A>PLAN OF DISTRIBUTION</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: justify">In this section of the prospectus,
the term &ldquo;Selling Stockholder&rdquo; means and includes:</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 0.25in; padding-right: 0.65pt; text-align: justify">&nbsp;</TD>
    <TD STYLE="vertical-align: top; width: 0.25in; padding-right: 0.65pt; text-align: justify">&#9679;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt; text-align: left">the persons identified in the table above as the Selling Stockholders;</TD></TR>
  <TR>
    <TD STYLE="padding-right: 0.65pt; text-align: left">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.65pt; text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&#9679;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.8pt; text-align: left">those persons whose identities are not known as of the date hereof but may in the future be eligible to receive options under the 2019 Plan or the 2022 Plan; and</TD></TR>
  <TR>
    <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left; vertical-align: top; padding-right: 1.05pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&#9679;</TD>
    <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">any of the donees, pledgees, distributees, transferees or other successors in interest of those persons referenced above who may: (a) receive any of the shares of our Common Stock offered hereby after the date of this prospectus and (b) offer or sell those shares hereunder.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The shares of our Common
Stock offered by this prospectus may be sold from time to time directly by the Selling Stockholders. Alternatively, the Selling Stockholders
may from time to time offer such shares through underwriters, brokers, dealers, agents or other intermediaries. The Selling Stockholders
as of the date of this prospectus have advised us that there were no underwriting or distribution arrangements entered into with respect
to the Common Stock offered hereby. The distribution of the Common Stock by the Selling Stockholders may be effected: in one or more transactions
that may take place on The Nasdaq Capital Market (including one or more block transactions) through customary brokerage channels, either
through brokers acting as agents for the Selling Stockholders, or through market makers, dealers or underwriters acting as principals
who may resell these shares on The Nasdaq Capital Market; in privately-negotiated sales; by a combination of such methods; or by other
means. These transactions may be effected at market prices prevailing at the time of sale, at prices related to such prevailing market
prices or at other negotiated prices. Usual and customary or specifically negotiated brokerage fees or commissions may be paid by the
Selling Stockholders in connection with sales of our Common Stock.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
may enter into hedging transactions with broker-dealers in connection with distributions of the shares or otherwise. In such transactions,
broker-dealers may engage in short sales of the shares of our Common Stock in the course of hedging the positions they assume with the
Selling Stockholders. The Selling Stockholders also may sell shares short and redeliver the shares to close out such short positions.
The Selling Stockholders may enter into option or other transactions with broker-dealers which require the delivery to the broker-dealer
of shares of our Common Stock. The broker-dealer may then resell or otherwise transfer such shares of Common Stock pursuant to this prospectus.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">At the time a particular
offering of shares of our Common Stock is made, a prospectus supplement, if required, will be distributed, which will set forth the name
of the Selling Stockholders, the aggregate amount of shares of our Common Stock being offered and the terms of the offering, including,
to the extent required, (1) the name or names of any underwriters, broker-dealers or agents, (2) any discounts, commissions and other
terms constituting compensation from the Selling Stockholders and (3) any discounts, commissions or concessions allowed or reallowed to
be paid to broker-dealers.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
also may lend or pledge shares of our Common Stock to a broker-dealer. The broker-dealer may sell the shares of Common Stock so lent,
or upon a default the broker-dealer may sell the pledged shares of Common Stock pursuant to this prospectus.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
will act independently of us in making decisions with respect to the timing, manner, and size of each resale or other transfer. There
can be no assurance that the Selling Stockholders will sell any or all of the shares of our Common Stock under this prospectus. Further,
we cannot assure you that the Selling Stockholders will not transfer, distribute, devise or gift the shares of our Common Stock by other
means not described in this prospectus. In addition, any Shares covered by this prospectus that qualify for sale under Rule&nbsp;144&nbsp;of
the&nbsp;Securities Act&nbsp;may be sold under Rule 144 rather than under this prospectus.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
have advised us that they have not entered into any agreements, understandings or arrangements with any underwriters or broker-dealers
regarding the sale of their securities. There is no underwriter or coordinating broker acting in connection with the proposed sale of
shares of Common Stock the Selling Stockholders.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Although the shares of Common
Stock covered by this prospectus are not currently being underwritten, the Selling Stockholders or their underwriters, brokers, dealers
or other agents or other intermediaries, if any, that may participate with the selling security holders in any offering or distribution
of Common Stock may be deemed &ldquo;underwriters&rdquo; within the meaning of the Securities Act and any profits realized or commissions
received by them may be deemed underwriting compensation thereunder.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Under applicable rules and
regulations under the Exchange Act, any person engaged in a distribution of shares of the Common Stock offered hereby may not simultaneously
engage in market making activities with respect to the Common Stock for a period of up to five days preceding such distribution. The Selling
Stockholders will be subject to the applicable provisions of the Exchange Act and the rules and regulations promulgated thereunder, including
without limitation Regulation M, which provisions may limit the timing of purchases and sales by the Selling Stockholders.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">In order to comply with certain
state securities or blue sky laws and regulations, if applicable, the Common Stock offered hereby will be sold in such jurisdictions only
through registered or licensed brokers or dealers. In certain states, the Common Stock may not be sold unless they are registered or qualified
for sale in such state, or unless an exemption from registration or qualification is available and is obtained.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">We will bear all costs, expenses
and fees in connection with the registration of the Common Stock offered hereby. However, the Selling Stockholders will bear any brokerage
or underwriting commissions and similar selling expenses, if any, attributable to the sale of the shares of Common Stock offered pursuant
to this prospectus. We have agreed to indemnify the Selling Stockholders against certain liabilities, including liabilities under the
Securities Act, or to contribute to payments to which any of those security holders may be required to make in respect thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_009"></A>LEGAL MATTERS</B></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-indent: 0.25in; text-align: left">The validity of the securities
being offered herein has been passed upon for us by Ellenoff Grossman &amp; Schole LLP, New York, New York.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_010"></A>EXPERTS</B></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-indent: 0.25in; text-align: left">The financial statements
of Blue Water Vaccines Inc. as of and for the&nbsp;years ended December&nbsp;31, 2021 and 2020, incorporated by reference in this registration
statement, of which this prospectus forms a part, have been audited by Mayer Hoffman McCann P.C., independent registered public accounting
firm, and are incorporated in reliance upon such report given on the authority of such firm as experts in auditing and accounting in giving
said report.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>DISCLOSURE OF COMMISSION POSITION ON</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INDEMNIFICATION FOR SECURITIES LAWS VIOLATIONS</B></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-indent: 0.25in; text-align: left">Section 145 of the DGCL inter
alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys&rsquo; fees),
judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
for such persons against expenses (including attorneys&rsquo; fees) actually and reasonably incurred in connection with the defense or
settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 further authorizes
a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Section 102(b)(7) of the
DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
provision shall not eliminate or limit the liability of a director (i) for any breach of the director&rsquo;s duty of loyalty to the corporation
or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
(iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
any transaction from which the director derived an improper personal benefit.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Article 6 of the bylaws of
the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
determined that such director is not entitled to indemnification.</P>

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

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

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<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: left; text-indent: 0.25in"><B>You should rely only on
the information contained in this document. We have not authorized anyone to provide you with information that is different. This document
may only be used where it is legal to sell these securities. The information in this document may only be accurate on the date of this
document.</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in"><B>Additional risks and uncertainties
not presently known or that are currently deemed immaterial may also impair our business operations. The risks and uncertainties described
in this document and other risks and uncertainties which we may face in the future will have a greater impact on those who purchase our
common stock. These purchasers will purchase our common stock at the market price or at a privately negotiated price and will run the
risk of losing their entire investment.</B></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: center"><B>BLUE WATER VACCINES INC.</B></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: center"><B>2,600,000 Shares of</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Common Stock</B></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: center">&nbsp;</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: center"><B>PROSPECTUS</B></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: center">&nbsp;</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: center">November 14, 2022</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"></P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PART II</B></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: center"><B>INFORMATION NOT REQUIRED IN PROSPECTUS</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 3.</B> <B>Incorporation of Documents by Reference</B></P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">We
are &ldquo;incorporating by reference&rdquo; in this prospectus certain documents we file with the Commission, which means that we can
disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
are incorporated herein by reference as of their respective dates of filing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.25in; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 0.25in; text-align: justify">(i)</TD>
    <TD STYLE="text-align: left">our Annual Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;</TD></TR>

<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(ii)</TD><TD STYLE="text-align: left">our Quarterly Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022026516/f10q0322_bluewatervac.htm">Form 10-Q</A> for the quarter ended March
31, 2022 as filed with the SEC on May 13, 2022; our Quarterly Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022048105/f10q0622_bluewater.htm">Form 10-Q</A> for the quarter ended June 30, 2022 as filed with the
SEC on August 15, 2022; and our Quarterly Report on <A HREF="https://www.sec.gov/Archives/edgar/data/1782107/000121390022072376/f10q0922_bluewater.htm">Form 10-Q</A> for the quarter ended September 30, 2022 as filed with the SEC on November
14, 2022&nbsp;;</TD>
</TR>
<TR STYLE="vertical-align: top; text-align: justify">
<TD>&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify; width: 0.25in">&nbsp;</TD>
    <TD STYLE="text-align: justify; width: 0.25in">(iii)</TD>
    <TD STYLE="text-align: left">our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022010779/ea156505-8ka1_bluewater.htm">Form
    8-K/A</A> dated March 4, 2022, our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022014172/ea157195-8k_bluewater.htm">Form
    8-K</A> dated March 22, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020636/ea158617-8k_bluewater.htm">Form
    8-K</A> dated April 19, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020726/ea158657-8k_bluewater.htm">Form
    8-K</A> dated April 20, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020785/ea158659-8k_bluewater.htm">Form
    8-K</A> dated April 20, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022020876/ea158704-8k_bluewater.htm">Form
    8-K</A> dated April 21, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022029402/ea160571-8k_bluewater.htm">Form
    8-K</A> dated May 25, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022030666/ea160890-8k_bluewater.htm">Form
    8-K</A> dated June 1, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022034900/ea161977-8k_bluewater.htm">Form&nbsp;8-K</A>
    dated June 24, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022036064/ea162286-8k_bluewater.htm">Form
    8-K</A> dated June 30, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022041300/ea163260-8k_bluewater.htm">Form
    8-K</A> dated July 25, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022046943/ea164234-8k_bluewater.htm">Form
    8-K</A> dated August 11, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022050150/ea164773-8k_bluewater.htm">Form
    8-K</A> dated August 22, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022055196/ea165633-8k_bluewater.htm">Form
    8-K</A> dated September 12, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022063031/ea166966-8k_bluewater.htm">Form
    8-K</A> dated October 11, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022063519/ea167009-8k_blue.htm">Form
    8-K</A> dated October 12, 2022; our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022069929/ea168219-8k_bluewater.htm">Form
    8-K</A> dated November 8, 2022; and our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022069929/ea168219-8k_bluewater.htm">Form 8-K</A> dated November 8, 2022; and our Current Report on <A HREF="http://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022070854/ea168392-8k_bluewatervac.htm">Form
    8-K</A> dated November 10, 2022.</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">(iv)</TD>
    <TD STYLE="text-align: left">the description of our securities registered under Section 12 of the Exchange Act as filed as&nbsp;<A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021ex4-2_bluewater.htm">Exhibit 4.2</A>&nbsp;on Annual Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">All documents that we file
with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
indicate that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold, will
be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Any statement contained in
a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
incorporated by reference.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You may request, orally or in writing, a copy
of these documents, which will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated
by reference), by contacting Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our
telephone number is (513) 620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However,
the information on our website is not a part of this prospectus and is not incorporated by reference.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 4.</B> <B>Description of Securities</B></P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">Not applicable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 5.</B> <B>Interests of Named Experts and Counsel</B></P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">Not applicable.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 6.</B> <B>Indemnification of Officers and Directors</B></P>


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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 of the DGCL inter
alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys&rsquo; fees),
judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
for such persons against expenses (including attorneys&rsquo; fees) actually and reasonably incurred in connection with the defense or
settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 further authorizes
a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 102(b)(7) of the
DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
provision shall not eliminate or limit the liability of a director (i) for any breach of the director&rsquo;s duty of loyalty to the corporation
or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
(iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
any transaction from which the director derived an improper personal benefit.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Article 6 of the bylaws of
the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
determined that such director is not entitled to indemnification.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 7.</B> <B>Exemption from Registration Claimed</B></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">Not applicable.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 8.</B> <B>Exhibits</B></P>


<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">The following exhibits are
filed with this Registration Statement.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 10%; text-align: center"><B>Number</B></TD>
    <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
    <TD STYLE="vertical-align: top; border-bottom: black 1.5pt solid; text-align: justify; width: 89%"><B>Description</B></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.1</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390021052037/fs12021ex10-1_bluewater.htm">2019 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.2</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-2_bluewater.htm">2022 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.3</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390021052037/fs12021ex10-3_bluewater.htm">2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (Incorporated by reference to Exhibit 10.3 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.4</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-4_bluewater.htm">2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.5</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-5_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (Incorporated by reference to Exhibit 10.5 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.6</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-6_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (Incorporated by reference to Exhibit 10.6 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">4.7</TD>
    <TD STYLE="text-align: left">&nbsp;</TD>
    <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-7_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatuory Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.7 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">5.1</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><A HREF="ea168413ex5-1_bluewater.htm">Opinion of Ellenoff Grossman &amp; Schole LLP (Filed herewith)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">23.1</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><A HREF="ea168413ex23-1_bluewater.htm">Consent of Mayer Hoffman McCann P.C. (Filed herewith)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">23.2</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><A HREF="ea168413ex5-1_bluewater.htm">Consent of Ellenoff Grossman &amp; Schole LLP (included in Exhibit 5.1)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">24</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><A HREF="#c_001">Powers of Attorney (included on signature page)</A></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White">
    <TD STYLE="text-align: center">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center">107</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: justify"><A HREF="ea168413ex-fee_bluewater.htm">Filing Fee Table. (Filed herewith)</A></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 9.</B> <B>Undertakings.</B></P>


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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">The undersigned registrant hereby undertakes:</TD>
</TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement</TD>
</TR></TABLE>

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

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">To include any material information with respect to the plan
of distribution not previously disclosed in the registration statement or any material change to such information in the registration
statement.</TD>
</TR></TABLE>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(2) That, for the purpose
of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(3) To remove from registration
by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">(4) That prior to any public reoffering of the
securities registered hereunder through use of a prospectus which is a part of this registration statement, by any person or party who
is deemed to be an underwriter within the meaning of Rule 145&copy;, such reoffering prospectus will contain the information called for
by the applicable registration form with respect to reofferings by persons who may be deemed underwriters, in addition to the information
called for by the other items of the applicable form.</P>

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

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

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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
    <!-- Field: /Page -->

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(5) That every prospectus
(i) that is filed pursuant to paragraph (4) immediately preceding, or (ii) that purports to meet the requirements of Section 10(a)(3)
of the Securities Act of 1933 and is used in connection with an offering of securities subject to Rule 415, will be filed as a part of
an amendment to the registration statement and will not be used until such amendment is effective, and that, for purposes of determining
any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide
offering thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(6) That, for purposes of
determining any liability under the Securities Act of 1933, each filing of the registrant&rsquo;s annual report pursuant to Section 13(a)
or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan&rsquo;s annual report
pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall
be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(7) To respond to requests
for information that is incorporated by reference into the joint proxy statement/prospectus pursuant to Item 4, 10(b), 11 or 13 of this
form, within one business day of receipt of such request, and to send the incorporated documents by first class mail or other equally
prompt means. This includes information contained in documents filed subsequent to the effective date of the registration statement through
the date of responding to the request.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(8) To supply by means of
a post-effective amendment all information concerning a transaction, and the company being acquired involved therein, that was not the
subject of and included in the registration statement when it became effective.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">(b) Insofar as indemnification for liabilities
arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a
claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director,
officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel
the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">(c) The undersigned registrant hereby undertakes
that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant&rsquo;s annual report
pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan&rsquo;s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time shall be deemed to be the initial bona fide offering thereof.</P>

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

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

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to the requirements of the Securities
Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized,
on November 14, 2022.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: justify"><B>BLUE WATER VACCINES INC.</B></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 60%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 4%; text-align: justify">&nbsp;</TD>
    <TD STYLE="width: 36%; text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">By:</TD>
    <TD STYLE="border-bottom: black 1.5pt solid">/s/ Joseph Hernandez</TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">Joseph Hernandez</TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">&nbsp;</TD>
    <TD STYLE="text-align: justify">Chief Executive Officer</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>

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

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    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="c_001"></A>POWER OF ATTORNEY</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in"><B>KNOW ALL MEN BY THESE PRESENTS</B>, that we,
the undersigned officers and directors of Blue Water Vaccines, Inc., a Delaware corporation, do hereby constitute and appoint Joseph Hernandez,
as his or her true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, for him and in his name,
place, and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and
other documents in connection therewith) to this Registration Statement and any subsequent registration statement filed by the registrant
pursuant to Rule&nbsp;462(b) of the Securities Act of 1933, as amended, which relates to this Registration Statement, and to file the
same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto
said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be
done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming
all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Pursuant to the requirements of the Securities Act
of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="width: 32%; border-bottom: black 1.5pt solid; padding-right: 3pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Name</B></FONT></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="width: 43%; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Position</B></FONT></TD>
    <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="width: 23%; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B>Date</B></FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    Joseph Hernandez</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chairman of the Board and Chief Executive Officer (Principal
    Executive Officer)</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR>
    <TD STYLE="vertical-align: top"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Joseph Hernandez</FONT></TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="vertical-align: bottom"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Chief Financial Officer
    (Principal Financial Officer)</FONT></TD>
    <TD STYLE="white-space: nowrap; vertical-align: bottom; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="vertical-align: bottom; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    Jon Garfield</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Jon Garfield</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    Kimberly Murphy</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Kimberly Murphy</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    James Sapirstein</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">James Sapirstein</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">/s/
    Simon Tarsh</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Simon Tarsh</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><P STYLE="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">/s/
                                            Vuk Jeremi&cacute;</FONT></P></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Director</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="text-align: center"><P STYLE="margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">November 14, 2022</FONT></P></TD></TR>
  <TR STYLE="vertical-align: bottom">
    <TD><P STYLE="margin: 0pt 0; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Vuk
        Jeremi&cacute;</FONT></P></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
    <TD STYLE="padding-bottom: 2.25pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  </TABLE>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">II-6</P>

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<DOCUMENT>
<TYPE>EX-5.1
<SEQUENCE>2
<FILENAME>ea168413ex5-1_bluewater.htm
<DESCRIPTION>OPINION OF ELLENOFF GROSSMAN & SCHOLE LLP
<TEXT>
<HTML>
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     <TITLE></TITLE>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: right"><B>Exhibit 5.1</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: right">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR>
    <TD STYLE="vertical-align: top; width: 50%; font-size: 10pt"><FONT STYLE="font-family: Sans-Serif; font-size: 9pt; color: Red"><B><IMG SRC="ex5-1_001.jpg" ALT=""></B></FONT></TD>
    <TD STYLE="width: 50%">
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">1345 AVENUE OF THE AMERICAS, 11<FONT STYLE="font-size: 10pt">th</FONT>
    FLOOR</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">NEW YORK, NEW YORK 10105</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">TELEPHONE: (212) 370-1300</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">FACSIMILE: (212) 370-7889</P>
    <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right">www.egsllp.com</P></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">November 14, 2022</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">Blue Water Vaccines Inc.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">201 E. Fifth Street, Suite 1900</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">Cincinnati, OH 45202</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">Re:</TD><TD STYLE="text-align: justify">Registration Statement on Form S-8</TD>
</TR></TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0in; text-align: justify">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">We have acted as
counsel to Blue Water Vaccines Inc., a Delaware corporation (the &ldquo;Company&rdquo;), in connection with the preparation of the Company&rsquo;s
Registration Statement on Form S-8 (the &ldquo;Registration Statement&rdquo;) being filed with the Securities and Exchange Commission
under the Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;). The Registration Statement has been filed to (i) register
1,000,000 shares (the &ldquo;Plan Shares&rdquo;) of Company common stock to be issued pursuant to the Blue Water Vaccines Inc. 2022 Equity
Incentive Plan (as amended, the &ldquo;2022 Plan&rdquo;), (ii) serve as a post-effective amendment, pursuant to Rule 429 under the Securities
Act, to our Registration Statement on Form S-8 (File No. 333-265843) filed with the Securities and Exchange Commission on June 24, 2022,
and (iii) register for resale up to 1,000,000 shares (collectively, the &ldquo;Resale Shares&rdquo;) of common stock issued or issuable
upon vesting or exercise of restricted stock awards or options issued under the 2022 Plan, such Resale Shares or related awards being
held by the executive officers and directors of the Company.</P>

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

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR>
    <TD STYLE="width: 100%; font-size: 10pt">In arriving at the opinion expressed below, we have examined and relied on the following documents:</TD></TR>
  </TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>
<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(1)</TD><TD STYLE="text-align: justify">the Amended and Restated Certificate of Incorporation and
Amended and Restated Bylaws of the Company, each as amended as of the date hereof;</TD>
</TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>
<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(2)</TD><TD STYLE="text-align: justify">the 2019 Plan</TD>
</TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>
<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(3)</TD><TD STYLE="text-align: justify">the 2022 Plan; and</TD>
</TR></TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
<TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(4)</TD><TD STYLE="text-align: justify">records of meetings and consents of the Board of Directors
of the Company provided to us by the Company.</TD>
</TR></TABLE>



<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">In addition, we
have examined and relied on the originals or copies certified or otherwise identified to our satisfaction of all such corporate records
of the Company and such other instruments and other certificates of public officials, officers and representatives of the Company and
such other persons, and we have made such investigations of law, as we have deemed appropriate as a basis for the opinion expressed below.
In such examination, we have assumed, without independent verification, the genuineness of all signatures (whether original or photostatic),
the accuracy and completeness of each document submitted to us, the authenticity of all documents submitted to us as originals, the conformity
to original documents of all documents submitted to us as facsimile, electronic, certified, conformed or photostatic copies thereof. We
have further assumed the legal capacity of natural persons, that persons identified to us as officers of the Company are actually serving
in such capacity, that the representations of officers and employees of the Company are correct as to questions of fact and that each
party to the documents we have examined or relied on (other than the Company) has the power, corporate or other, to enter into and perform
all obligations thereunder and also have assumed the due authorization by all requisite action, corporate or other, of the execution and
delivery by such parties of such documents, and the validity and binding effect thereon on such parties. We have also assumed that the
Company will not in the future issue or otherwise make unavailable so many shares of its common stock that there are insufficient authorized
and unissued shares of common stock for issuance of the shares issuable upon exercise of the options being registered in the Registration
Statement. We have not independently verified any of these assumptions.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">The opinions expressed
in this opinion letter are limited to the General Corporation Law of the State of Delaware. We are not opining on, and we assume no responsibility
for, the applicability or effect on any of the matters covered herein of: (a) any other laws; (b) the laws of any other jurisdiction;
or (c) the laws of any country, municipality or other political subdivision or local government agency or authority. The opinions set
forth below are rendered as of the date of this opinion letter. We assume no obligation to update or supplement such opinions to reflect
any change of law or fact that may occur.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify; text-indent: 0.5in"></P>

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    <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><P STYLE="text-align: center; margin-top: 0pt; margin-bottom: 0pt">&nbsp;</P></DIV>
    <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
    <!-- Field: /Page -->

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">Based upon and subject
to the foregoing, it is our opinion that the Plan Shares have been duly authorized and, upon issuance and payment therefor in accordance
with the terms of the 2022 Plan, and the awards, agreements or certificates issued thereunder, will be validly issued, fully paid and
nonassessable.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.5in">We hereby consent
to the filing of this opinion as an exhibit to the Registration Statement. In giving such consent, we do not thereby admit that we are
experts with respect to any part of the Registration Statement within the meaning of the term &ldquo;expert&rdquo; as used in Section
11 of the Securities Act or the rules and regulations promulgated thereunder by the Securities and Exchange Commission, nor do we admit
that we are within the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations
of the Securities and Exchange Commission promulgated thereunder.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in; text-align: justify; text-indent: 0.5in">&nbsp;</P>

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  <TR>
    <TD STYLE="width: 60%">&nbsp;</TD>
    <TD STYLE="width: 40%; font-size: 10pt">Yours truly,</TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt">/s/ Ellenoff Grossman &amp; Schole LLP</TD></TR>
  <TR>
    <TD>&nbsp;</TD>
    <TD STYLE="font-size: 10pt">Ellenoff Grossman &amp; Schole LLP</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.1in"></P>

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<DOCUMENT>
<TYPE>EX-23.1
<SEQUENCE>3
<FILENAME>ea168413ex23-1_bluewater.htm
<DESCRIPTION>CONSENT OF MAYER HOFFMAN MCCANN P.C.
<TEXT>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: right"><B>Exhibit 23.1</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>CONSENT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM</B></P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">We consent to the incorporation by
reference in this Registration Statement on Form S-8 and related prospectus of our report dated March 18, 2022, with respect to the financial
statements of Blue Water Vaccines Inc. as of December 31, 2021 and 2020, and for the two years then ended, included in the Annual Report
on Form 10-K filed with the Securities and Exchange Commission on March 31, 2022 and to the reference to us under the heading &ldquo;Experts&rdquo;
in the prospectus which is part of this Registration Statement.</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">/s/ Mayer Hoffman McCann P.C.</P>

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0pt">November 14, 2022</P>

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</DOCUMENT>
<DOCUMENT>
<TYPE>EX-FILING FEES
<SEQUENCE>4
<FILENAME>ea168413ex-fee_bluewater.htm
<DESCRIPTION>CALCULATION OF FILING FEE TABLES
<TEXT>
<HTML>
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<P STYLE="margin: 0pt; text-align: right"><B>Exhibit 107.1</B></P>

<P STYLE="margin: 0pt; text-align: right">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>Calculation of Filing Fee Tables</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>Form S-8</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>(Form Type)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>Blue Water Vaccines Inc.</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><B>(Exact Name of Registrant as Specified in
its Charter)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: center"><U>Table 1: Newly Registered Securities</U></P>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom">
    <TD STYLE="text-align: center; border-bottom: Black 1.5pt solid">Security Type</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: center; border-bottom: Black 1.5pt solid">Security<BR> Class <BR>Title</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: center; border-bottom: Black 1.5pt solid">Fee<BR> Calculation<BR> Rule</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Amount<BR> Registered(1)</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Proposed<BR> Maximum<BR> Offering<BR> Price Per<BR> Share</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Maximum<BR> Aggregate<BR> Offering <BR>Price</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Fee <BR>Rate</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Amount of<BR> Registration <BR>Fee</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="width: 12%; text-align: center; padding-bottom: 1.5pt">Equity</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 12%; text-align: center; padding-bottom: 1.5pt">Common Stock</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 12%; text-align: right; padding-bottom: 1.5pt">Other</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="width: 10%; border-bottom: Black 1.5pt solid; text-align: right">1,000,000</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt; text-align: left">(2)</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="width: 10%; border-bottom: Black 1.5pt solid; text-align: right">1.305</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt; text-align: left">(3)</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="width: 9%; border-bottom: Black 1.5pt solid; text-align: right">1,305,000</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; border-bottom: Black 1.5pt solid; text-align: right">0.00011020</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="width: 1%; border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="width: 9%; border-bottom: Black 1.5pt solid; text-align: right">143.82</TD><TD STYLE="width: 1%; padding-bottom: 1.5pt; text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="text-align: center; padding-bottom: 1.5pt">Equity</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: center; padding-bottom: 1.5pt">Common Stock</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: right; padding-bottom: 1.5pt">Other</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">1,600,000</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">(4)</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">N/A</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">N/A</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">N/A</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">N/A</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center; padding-bottom: 1.5pt">Total Offering Amounts</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">N/A</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">143.82</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
    <TD STYLE="text-align: center; padding-bottom: 1.5pt">Total Fee Offsets</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">-&nbsp;&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
    <TD STYLE="text-align: center; padding-bottom: 1.5pt">Net Fee Due</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">&nbsp;</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
    <TD STYLE="border-bottom: Black 1.5pt solid; text-align: left">$</TD><TD STYLE="border-bottom: Black 1.5pt solid; text-align: right">143.82</TD><TD STYLE="padding-bottom: 1.5pt; text-align: left">&nbsp;</TD></TR>
  </TABLE>

<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; font-size: 10pt">(1)</TD>
    <TD STYLE="width: 95%; font-size: 10pt; text-align: justify">Pursuant to Rule 416 under the Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), this Registration Statement on Form S-8 shall also cover any additional shares of the Registrant's common stock that become issuable in respect of the securities identified in the above table by reason of any stock dividend, stock split, recapitalization or other similar transaction effected without the Registrant's receipt of consideration which results in an increase in the number of the outstanding shares of the Registrant's common stock. In addition, this Registration Statement covers the resale by certain selling stockholders named in the prospectus included in and filed with this Registration Statement of certain of the shares of Registrant&rsquo;s common stock subject to this Registration Statement, for which no additional registration fee is required pursuant to Rule 457(h)(3).</TD></TR>
  </TABLE>
<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; font-size: 10pt">(2)</TD>
    <TD STYLE="width: 95%; font-size: 10pt; text-align: justify">Shares of common stock issuable pursuant to the Blue Water Vaccines Inc. 2022 Equity Incentive Plan, as amended (the &ldquo;2022 Plan&rdquo;). The proposed maximum offering price per share and registration fee were calculated in accordance with Rule 457(c) based on the average of the high and low prices reported in the consolidated reporting system within 5 business days prior to the date of filing the Registration Statement.</TD></TR>
  </TABLE>
<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; font-size: 10pt">(3)</TD>
    <TD STYLE="width: 95%; font-size: 10pt; text-align: justify">Estimated solely for the purpose of calculating the registration fee pursuant to Rules 457(c) and 457(h) of the Securities Act, based on $1.305, the average of the high and low sales price of a share of Common Stock as reported on Nasdaq on November 11, 2022.</TD></TR>
  </TABLE>
<P STYLE="margin-top: 0; margin-bottom: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 5%; font-size: 10pt">(4)</TD>
    <TD STYLE="width: 95%; font-size: 10pt; text-align: justify">Shares of common stock issuable pursuant to the Blue Water Vaccines Inc. 2019 Equity Incentive Plan and the 2022 Plan have been previously registered on a registration statement on Form S-8 (File No. 333-265843). As described in more detail in the Explanatory Note, pursuant to Rule 429 under the Securities Act this Registration Statement is deemed to be a post-effective amendment to the Registrant&rsquo;s registration statement on Form S-8 (File No. 333-265843).</TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt">&nbsp;</P>

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<TYPE>GRAPHIC
<SEQUENCE>5
<FILENAME>image_001.jpg
<DESCRIPTION>GRAPHIC
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
