<SEC-DOCUMENT>0001104659-22-093694.txt : 20220823
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<ACCEPTANCE-DATETIME>20220823160816
ACCESSION NUMBER:		0001104659-22-093694
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		13
CONFORMED PERIOD OF REPORT:	20220823
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20220823
DATE AS OF CHANGE:		20220823

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Innoviva, Inc.
		CENTRAL INDEX KEY:			0001080014
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				943265960
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-30319
		FILM NUMBER:		221187558

	BUSINESS ADDRESS:	
		STREET 1:		1350 OLD BAYSHORE HIGHWAY
		STREET 2:		SUITE 400
		CITY:			BURLINGAME
		STATE:			CA
		ZIP:			94010
		BUSINESS PHONE:		6502389600

	MAIL ADDRESS:	
		STREET 1:		1350 OLD BAYSHORE HIGHWAY
		STREET 2:		SUITE 400
		CITY:			BURLINGAME
		STATE:			CA
		ZIP:			94010

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	THERAVANCE INC
		DATE OF NAME CHANGE:	20020207

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ADVANCED MEDICINE INC
		DATE OF NAME CHANGE:	20000302
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<p style="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>UNITED STATES</b></p>

<p style="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>SECURITIES AND EXCHANGE<br />
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Washington, DC 20549</b>&#160;</p>

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>CURRENT REPORT</b></p>

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Pursuant to Section&#160;13 or 15(d)&#160;of
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1934</b>&#160;</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact Name of Registrant as Specified in
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<p style="font: 3pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&#160;</p>

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

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(I.R.S. Employer Identification Number)</p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Addresses, including zip code, and telephone
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Former name or former address, if changed since
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: left; margin-bottom: 0pt">Check the appropriate box below if the Form&#160;8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):</p>

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

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<tr style="vertical-align: top">
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>

<p style="margin-top: 0in; text-align: left; margin-bottom: 0pt"><span style="font: x-small Times New Roman; font-size: 10pt">Securities registered pursuant to Section&#160;12(b)&#160;of the Act:</span></p>
<p style="margin: 0in 0in 0pt"><span style="font: x-small Times New Roman; font-size: 10pt">&#160;</span></p>

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Symbol(s)</span></td>
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<p style="margin: 0in 0in 0pt">&#160;</p>

<p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; text-align: left; margin-bottom: 0pt">Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule&#160;405 of the Securities Act of 1933(&#167;230.405 of this chapter) or Rule&#160;12b-2
of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter).</p>

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

<p style="margin: 0pt 0; font-size: 10pt; text-align: right"><span style="font: 10pt Times New Roman, Times, Serif">Emerging
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 7pt; text-indent: 393.5pt">&#160;</p>

<p style="font-size: 10pt; margin-top: 0pt; text-align: left; margin-bottom: 0pt"><span style="font: 10pt Times New Roman, Times, Serif">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&#160;13(a)&#160;of the Exchange Act. <span style="font-family: Wingdings">&#168;</span></span></p>

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

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<p style="margin-top: 0pt; margin-bottom: 0pt">&#160;&#160;</p>

<p style="margin-top: 0pt; margin-bottom: 0pt"><b>Item 8.01. Other Events.</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company is filing this Form 8-K for the purposes of supplementing
and updating its risk factors from the disclosure contained in the Company&#8217;s prior filings with the Securities and Exchange Commission
(&#8220;SEC&#8221;), including the Company&#8217;s Quarterly Report on <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1080014/000095017022013224/inva-20220630.htm" style="-sec-extract: exhibit">Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on July 27, 2022</a> and the Company&#8217;s <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1080014/000095017022002169/inva-20211231.htm" style="-sec-extract: exhibit">Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 28, 2022</a> and <a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1080014/000095017022004088/inva-20211231.htm" style="-sec-extract: exhibit">amended March 17, 2022</a>. The updated risk factors are filed herewith as Exhibit 99.1 and are incorporated herein by reference.</p>

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>Item 9.01. Financial Statements and Exhibits.</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><b>(d) Exhibits</b></p>

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

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  <td style="padding-left: 10pt; text-indent: -10pt"><a href="tm2224315d1_ex99-1.htm" style="-sec-extract: exhibit">Risk Factors</a></td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</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; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><b>SIGNATURE</b></p>

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

<p style="font: 10pt Times New Roman, Times, Serif; margin-left: 0.5in; text-align: left; margin-top: 0pt; margin-bottom: 0pt">Pursuant to the requirements of
the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.</p>

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

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    <td><span style="font-size: 10pt">Date: August 23, 2022</span></td>
    <td colspan="2"><span style="font-size: 10pt"><b>INNOVIVA, INC.</b></span></td></tr>
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    <td>&#160;</td>
    <td colspan="2">&#160;</td></tr>
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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#160;</p>

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

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                           <P STYLE="margin: 0pt">&nbsp;</P>

<P STYLE="text-align: right; margin: 0pt"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0pt">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Item&nbsp;1A. Risk Factors</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: 0.5in">The information presented below supplements the
risk factors set forth in Item 1A of Part&nbsp;I of our 2021 Form&nbsp;10-K. Except as set forth below, for additional risk factors that
could cause actual results to differ materially from those anticipated, please refer to Item 1A of Part&nbsp;I of our 2021 Form&nbsp;10-K.
Innoviva, its subsidiaries and any investments held directly or indirectly by Innoviva, at the time of this filing, shall be referred
to as &#8220;Innoviva,&#8221; &#8220;we&#8221;, &#8220;us&#8221;, or &#8220;our&#8221; for purposes of this Item 1A.</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 success in preclinical studies or clinical trials may not
be indicative of results in current or future clinical trials.</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: 0.5in">Our success in preclinical testing and early clinical
trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the
efficacy and safety of a product candidate. Certain product candidates may fail to show the necessary safety and efficacy in clinical
development despite positive results in preclinical studies or having successfully advanced through initial clinical trials.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design
of a clinical trial may not become apparent until the clinical trial is well advanced. </FONT>We have limited experience designing clinical
trials and may be unable to design and execute a clinical trial to support regulatory approval. There is a high failure rate for drugs
and biologic products proceeding through clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical
trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent
regulatory approval. In addition, we may experience regulatory delays or rejections because of many factors, including changes in regulatory
policy during the period of our product candidate development. Any such delays could negatively impact 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>If clinical trials of our product candidates fail to demonstrate
safety and efficacy to the satisfaction of the FDA, the EMA or other comparable regulatory authorities, or do not otherwise produce favorable
results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization
of that product candidate.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>,
or our potential collaborators, may not commercialize, market, promote, or sell any product candidate without obtaining marketing approval
from the FDA, the EMA or other comparable regulatory authority, and we may never receive such approvals. Even if our product candidates
appear sufficiently effective and/or safe in patients in well-controlled clinical trials, it is impossible to predict if or when these
product candidates will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any
product candidate, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy
of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete
and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. Moreover, preclinical and
clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates
performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their 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"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
may experience numerous unforeseen events prior to, during, or because of, clinical trials that could delay or prevent our ability to
receive marketing approval or commercialize our product candidates, including:</P>

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

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    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the FDA, the EMA or other comparable regulatory authority may change from the views they have expressed to us as to the design, implementation, and/or interpretation of our clinical trials;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may not reach agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;</FONT></TD></TR>
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    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we</FONT> may not be able to complete our clinical trials in a timely manner, if at all, for example because the number of patients required for clinical trials of our product candidates may be larger than we anticipate;</TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">enrollment in these clinical trials may be slower than we anticipate, participants may drop out of these clinical trials at a higher rate than we anticipate, or we may fail to recruit suitable patients to participate in a trial;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may fail to comply with regulatory requirements applicable to them, to the FDA&#8217;s or other comparable regulatory authority&#8217;s, satisfaction;</FONT></TD></TR>
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    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;</FONT></TD></TR>
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    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
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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-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
</FONT>we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently
contemplate, if we are unable to successfully complete clinical trials or other testing of those product candidates, or if the results
of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 1%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 96%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">be delayed in obtaining marketing approval for our product candidates;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">not obtain marketing approval at all;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain approval for indications or patient populations that are not as broad as intended or desired;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, such as black box warnings or a REMS program;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">be subject to additional post-marketing testing requirements; or</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">be required to remove the product from the market after obtaining marketing approval.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
</FONT> product development costs may also increase if we experience delays in testing and we may be required to obtain additional funds
to complete clinical trials. We do not know whether any of our preclinical studies or clinical trials will begin as planned, will need
to be restructured or will be completed on schedule, or at all. Significant preclinical study or clinical trial delays also could shorten
any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products
to market before we do and impair our ability to successfully commercialize our product candidates. In addition, many of the factors that
cause, or lead to, delays of clinical trials may ultimately lead to the denial of regulatory approval of a product candidate.</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
</I></B></FONT><B><I>we are not successful in discovering, developing, and commercializing additional product candidates, our ability
to expand and achieve our strategic objectives would be impaired.</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: 0.5in">Although a substantial amount of our effort will
focus on the continued clinical testing and potential regulatory approval of our product candidates, an element of our strategy is to
develop and commercialize, either by ourselves or with a collaborator, our product candidates and discover and develop novel product candidates
in other therapeutic areas. We are seeking to do so by utilizing our discovery research experience and capabilities to design active new
compounds that target causative mechanisms of disease. Research efforts to identify and develop product candidates require substantial
technical, financial and human resources, whether or not any product candidates are ultimately identified. Our research programs may initially
show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons,
including the following:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 1%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 96%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the research methodology used may not be successful in identifying potential product candidates;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">competitors may develop alternatives that render our product candidates obsolete or less attractive;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">product candidates we develop may nevertheless be covered by third parties&#8217; patents or other exclusive rights;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

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<P STYLE="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 1%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 96%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the FDA, the EMA or other regulatory authorities may not approve or agree with the intended use of a new product candidate.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
</FONT>we fail to develop and successfully generate revenue from other current and future product candidates, our future prospects may
be harmed, and we will be more vulnerable to any problems that we or potential collaborators may encounter in developing and commercializing
our current 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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>If
</I></B></FONT><B><I>we or our collaborators experience delays or difficulties in the enrollment of patients in clinical trials, our receipt
of necessary regulatory approvals could be delayed or prevented.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
may not be able to initiate, continue or complete clinical trials of our product candidates that we develop if we and our collaborators
are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, the EMA
or other comparable regulatory authority. We have limited experience enrolling patients in our clinical trials and cannot predict how
successful we will be in enrolling patients in future clinical trials.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">For
instance, patients involved in </FONT>our clinical trials are often in the hospital setting and the decision to participate can be
made by the caregiver or doctor. Accordingly, seeking consent for patient participation may become difficult when the family and/or
the patient may not be available to consider participation in a clinical trial and the providers/investigators seeking the consent
often have no established relationship with the family or patient. The challenges of obtaining consent for patient participation
have increased during the COVID-19 pandemic as hospitals have imposed restrictions on visitation by friends or family members who
may be able to provide consent on behalf of patients. The COVID-19 pandemic may make patients less willing to seek medical attention
or return for follow-up visits post-treatment. In addition, some of our competitors have ongoing clinical trials to treat the same
indications as our product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in
clinical trials of our competitors. If we are not successful at enrolling patients in one clinical trial, it may affect when we are
able to initiate the next clinical trial, which could result in significant delays in our efforts to pursue regulatory approval of
and commercialize our product candidates. Patient enrollment is affected by other factors including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the size and nature of the patient population;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the severity of the disease under investigation;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the proximity and availability of clinical trial sites for prospective patients;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the eligibility criteria for participation in the clinical trial;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the design of the clinical trial;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the perceived risks and benefits of the product candidate under study;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to recruit clinical trial investigators with appropriate experience;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the availability of drugs approved to treat the diseases under study;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the patient referral practices of physicians;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our ability to obtain and maintain patient consents;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></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="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the ability to monitor patients adequately during and after treatment;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the risk that patients enrolled in clinical trials will drop out of the trials before completion; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the impact of public health epidemics, such as the COVID-19 pandemic.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
</FONT>inability to enroll a sufficient number of patients for clinical trials would result in significant delays and could require us
to abandon one or more clinical trials altogether. Enrollment delays in these clinical trials may result in increased development costs
for our product candidates, which would reduce the capital we have available to support current and future product candidates and may
result in the need to raise additional capital earlier than planned and could cause the value of our common stock to decline and limit
our ability to obtain additional financing.</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Our</I></B></FONT><B><I>
product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval,
limit the commercial potential or result in significant negative consequences following any potential marketing approval.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">During
the conduct of clinical trials, patients report changes in their health, including illnesses, injuries and discomforts (generally referred
to as adverse events), to their doctor. We are required to report adverse events to the FDA and other regulatory authorities. Often, it
is not possible to determine whether the product candidate being studied caused these conditions. Regulatory authorities may draw different
conclusions or require additional testing to confirm or refute these observations, if they occur. In addition, it is possible that as
</FONT>we test our product candidates in larger, longer and more extensive clinical programs, or as use of these product candidates becomes
more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier
trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by subjects. Many times, side
effects are only detectable after investigational drugs are tested in large-scale, Phase&#8239;3 clinical trials or, in some cases, after
they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that any of our
current product candidates or any future product candidates, have side effects or causes serious or life-threatening side effects, the
development of the product candidate may fail or be delayed, or, if the product candidate has received regulatory approval, such approval
may be revoked, which could harm our business, prospects, operating results and 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Moreover,
if </FONT>we elect, or are required, to delay, suspend or terminate any clinical trial of our product candidates, the commercial prospects
of our product candidates may be harmed and our ability to generate revenue through their sale may be delayed or eliminated. Any of these
occurrences may significantly harm our business, financial condition 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Additionally,
if any of our product candidates receive marketing approval, regulatory authorities may require the addition of labeling statements, such
as a &#8220;black box&#8221; warning or a contraindication, or the adoption of a REMS program to ensure that the benefits outweigh its
risks, which may include, among other things, a medication guide outlining the risks of the drug for distribution to patients and a communication
plan to health care practitioners, and/or significant restrictions on distribution or use of the drug. Furthermore, if </FONT>we or others
later identify undesirable side effects caused by our product candidates, several potentially significant negative consequences could
result, including:</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="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory authorities may suspend or withdraw approvals of such product candidate;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">regulatory authorities may require additional warnings on the label or impose distribution or use restrictions;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may be required to change the way a product candidate is administered or conduct additional clinical trials, including one or more post-market studies;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we could be sued and held liable for harm caused to patients;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

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<P STYLE="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may be required to implement a REMS, including the creation of a medication guide outlining the risks of such side effects for distribution to patients, and/or other elements to assure safe use;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">we may need to conduct a recall; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our reputation may suffer.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
of these events could prevent </FONT>us from achieving or maintaining market acceptance of the affected product candidate, if approved,
or could substantially increase commercialization costs and expenses, which could delay or prevent us from generating revenue from the
sale of our products and harm our business 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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>Interim
 &#8220;top-line&#8221; and preliminary data from </I></B></FONT><B><I>our clinical trials that we announce or publish from time to time
may change as more patient data become available and are subject to audit and verification procedures that could result in material changes
in the final data.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">From
time to time, </FONT>we may announce interim top-line or preliminary data from our clinical trials. Interim data from clinical trials
that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues
and/or more patient data become available. Preliminary or top-line data also remain subject to audit and verification procedures that
may result in the final data being materially different from the preliminary data we previously published. As a result, interim and preliminary
data should be viewed with caution until the final data are available. Differences between preliminary or interim data and final data
could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.</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 environmental, health and safety laws
and regulations, we could become subject to fines or penalties or incur costs that could harm 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: 0.5in">We are subject to numerous environmental, health
and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal
of hazardous materials and wastes. Our operations involve the use of hazardous materials, including chemicals and biological materials.
Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and
wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting
from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources.
We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.</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: 0.5in">Although we maintain workers&#8217; compensation
insurance to cover us for costs and&nbsp;expenses&nbsp;we may incur due to injuries to our employees resulting from the use of hazardous
materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental
liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.</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 Our Dependence on Third Parties</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We</I></B></FONT><B><I>
rely on third parties to conduct the clinical trials for our product candidates, and those third parties may not perform satisfactorily,
including failing to meet deadlines for the completion of such trials or failing to comply with applicable regulatory requirements.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
have engaged contract research organizations, or CROs, to conduct our ongoing and planned clinical trials. We also expect to engage CROs
for any of our other product candidates that may progress to clinical development. We expect to rely on CROs, as well as other third parties,
such as clinical data management organizations, medical institutions and clinical investigators, to conduct those clinical trials. Agreements
with such third parties might terminate for a variety of reasons, including a failure to perform by the third parties. If we need to enter
into alternative arrangements, our product development activities would be delayed.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
reliance on these 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 requires us to comply with regulatory standards,
commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure
that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are
protected. Similar regulatory requirements apply outside the United States, including the International Council for Harmonisation of Technical
Requirements for the Registration of Pharmaceuticals for Human Use, or ICH.</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: 0.5in">We are also required to register certain ongoing
clinical trials and post the results of certain completed clinical trials on government-sponsored, publicly accessible databases, such
as ClinicalTrials.gov, within specified timeframes. Failure to do so by us or by third parties can result in FDA refusal to approve applications
based on the clinical data, enforcement actions, adverse publicity and civil and criminal sanctions.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Furthermore,
these third parties may also have relationships with other entities, some of which may be </FONT>our competitors. If these third parties
do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory
requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product
candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, principal investigators for </FONT>our clinical trials may serve as scientific advisors or consultants to us from time to time
and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result
in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the results of the
trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial
itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA we submit. Any such delay or rejection could
prevent us from commercializing our 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
</FONT>also expect to rely on other third parties to store and distribute product supplies for our clinical trials. Any performance failure
or regulatory noncompliance on the part of our distributors could delay clinical development or marketing approval of our product candidates
or commercialization of our products, resulting in additional losses and depriving us of potential product revenue.</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"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><B><I>We</I></B></FONT><B><I>
rely on collaborations with third parties for the development of our product candidates, and we may seek additional collaborations in
the future. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
have limited capabilities for drug development, and our product development programs and the commercialization of our product candidates
will require substantial additional cash to fund expenses. As a result of these factors, we are, and expect to continue to be, dependent
on collaborations relating to the development of our existing and future product candidates. We have had and will continue to have discussions
on potential partnering opportunities with various pharmaceutical companies. In addition, we may seek third-party collaborators for the
development and commercialization of our product candidates, particularly for the commercialization of our product candidates outside
the United States. Likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional
and national pharmaceutical companies and biotechnology companies and we may face significant competition in seeking appropriate collaborators.
If we fail to enter into or maintain collaborations on reasonable terms or at all, our ability to develop our existing or future product
candidates could be delayed, the commercial potential of our products could change, and our costs of development and commercialization
could increase. If we enter into any future collaboration arrangements with any third parties, we will likely have limited control over
the amount and timing of resources that our collaborators dedicate to the development or commercialization of our product candidates.
Our ability to generate revenues from these arrangements will depend on our collaborators&#8217; abilities to successfully perform the
functions assigned to them in these arrangements.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
collaborations and any future collaborations we might enter into may pose a number of risks, including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators often have significant discretion in determining the efforts and resources that they will apply to these collaborations;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may not perform their obligations as expected or contractually obligated;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators&#8217; strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our product candidates;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may not properly maintain or defend our or their intellectual property rights or may use our or their proprietary information in such a way as to invite litigation that could jeopardize or invalidate such intellectual property or proprietary information or expose us to potential litigation;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators may be subject to geo-political actions, natural disasters or other occurrences, including public health epidemics such as the COVID-19 pandemic;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">collaborators&#8217; decisions may limit the availability of the product supplies required for development, clinical and commercial activities.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Collaboration agreements may not lead to development
or commercialization of product candidates in the most efficient manner or at all. If a present or future collaborator were to be involved
in a business combination, the continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished
or terminated.</P>

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

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

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our reliance on third parties to manufacture our product candidates
increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable
cost, which could delay, prevent or impair our development or commercialization efforts.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
do not own or operate manufacturing facilities to produce clinical or commercial supplies of the product candidates that we are developing
or evaluating. We have limited personnel with experience in drug manufacturing and lack the resources and the capabilities to manufacture
any of our product candidates on a clinical or commercial scale. We currently rely on third parties for supply of our product candidates,
and our strategy is to outsource all manufacturing of our product candidates and approved products, if any, to third parties.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
conduct clinical trials of </FONT>our product candidates, we will need to identify suitable manufacturers with the capabilities to manufacture
our compounds in large quantities in a manner consistent with existing regulations. Our third-party manufacturers may be unable to successfully
increase the manufacturing capacity for any of our product candidates in a timely or cost-effective manner, or at all. In addition, quality
issues may arise during scale-up activities and at any other time. If our manufacturers are unable to successfully scale up the manufacture
of our product candidates in sufficient quality and quantity, the development, testing and clinical trials of that product candidate may
be delayed, or infeasible, and regulatory approval or commercial launch of that product candidate may be delayed or not obtained, which
could significantly 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if </FONT>we can establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails risks,
including:</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="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reliance on the third party for regulatory compliance and quality assurance;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the possible breach of the manufacturing agreement by the third party;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the possible misappropriation of our proprietary information, including our trade secrets and know-how;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">supply chain disruptions due to geo-political actions, natural disasters or public healthy crises, including epidemics such as the COVID-19 pandemic.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Third-party
manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. </FONT>Our
failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed
on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls
of product candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
supplies of our 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit
margins and our ability to develop product candidates and commercialize any products that receive marketing approval on a timely and competitive
basis.</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 not be able to win government or non-profit contracts
or grants to fund our product development activities.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Historically,
</FONT>we have relied in part on funding from contracts or grants from government agencies and non-profit entities and it is part of our
strategy to continue to do so. Such contracts or grants can be highly attractive because they provide capital to fund the ongoing development
of our product candidates without diluting our stockholders. However, there is often significant competition for these contracts or grants.
Entities offering contracts or grants may have requirements to apply for or to otherwise be eligible to receive certain contracts or grants
that our competitors may be able to satisfy that we cannot. In addition, such entities may make arbitrary decisions as to whether to offer
contracts or make grants, to whom the contracts or grants will be awarded, and the size of the contracts or grants to each awardee. Even
if we can satisfy the award requirements, there is no guarantee that we will be selected to receive any contract or grant. If we are not
successful in achieving this form of funding for our clinical trials, we will need to seek alternative means of funding which may not
be available to the same extent, if at all.</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 reliance on government funding for certain of our programs
adds uncertainty to our research, development and commercialization efforts with respect to those programs and may impose requirements
that increase the costs of the research, development and commercialization of product candidates 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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aspects
of certain of </FONT>our development programs are currently being supported, in part, with funding from the NIH, NIAID, CARB-X and the
DOD. Contracts and grants awarded by the U.S. government, its agencies and its partners, including our awards from the NIH, NIAID, CARB-X,
and the DOD, include provisions that reflect the government&#8217;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">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 1%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 96%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">terminate agreements, in whole or in part, for any reason or no reason at all;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">provide grant support to potential competitor programs;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduce or modify the government&#8217;s obligations under such agreements without the consent of the other party;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">claim rights, including intellectual property rights, in products and data developed under such agreements;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">audit contract-related costs and fees, including allocated indirect costs;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspend or debar the contractor or grantee from doing future business with the government;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">control and potentially prohibit the export of products;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">pursue criminal or civil remedies under the False Claims Act, False Statements Act and similar remedy provisions specific to government agreements; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">limit the government&#8217;s financial liability to amounts appropriated by the U.S. 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.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

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

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
may not have the right to prohibit the U.S. government from using certain technologies developed by us, and may not be able to prohibit
third-party companies, including our competitors, from using those technologies in providing products and services to the U.S. government.
The U.S. government generally takes the position that it has the right to royalty-free use of technologies that are developed under U.S.
government contracts.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, government contracts and grants, and subcontracts and subawards awarded in the performance of those contracts and grants, normally
contain additional requirements that may increase </FONT>our costs of doing business, reduce our profits, and expose us to liability for
failure to comply with these terms and conditions. These requirements include, for example:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">specialized accounting systems unique to government awards;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">mandatory financial audits and potential liability for price adjustments or recoupment of government funds after such funds have been spent;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">adhering to stewardship principles imposed by CARB-X as a condition of the award;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">public disclosures of certain award information, which may enable competitors to gain insights into our research program; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and affirmative action programs and environmental compliance requirements.</FONT></TD></TR>
  </TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
an organization, </FONT>we are relatively new to government contracting and new to the regulatory compliance obligations that such contracting
entails. If we fail to maintain compliance with those obligations, we may be subject to potential liability and termination of our contracts.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">As
a U.S. government contractor, </FONT>we are subject to financial audits and other reviews by the U.S. government of our costs and performance
on our contracts, as well as our accounting and general business practices related to these contracts. Based on the results of its audits,
the government may adjust our contract-related costs and fees, including allocated indirect costs.</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 the Commercialization of Our Product Candidates</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>Even if any of our product candidates receives marketing approval,
such product candidate may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the
medical community necessary for commercial success.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if </FONT>we obtain approvals from the FDA, the EMA or other comparable regulatory agencies and can initiate commercialization of a product
candidate we develop, the product candidate may not achieve market acceptance among physicians, patients, hospitals, including pharmacy
directors, and third-party payors and, ultimately, may not be commercially successful. The degree of market acceptance of our product
candidates, if approved for commercial sale, will depend on several factors, including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the efficacy and potential advantages compared to alternative treatments;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the potential and perceived advantages and disadvantages of the product candidates, including cost and clinical benefit relative to alternative treatments;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the convenience and ease of administration compared to alternative treatments;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

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<P STYLE="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">acceptance by physicians, patients, operators of hospitals, including in-hospital formularies, and treatment facilities and parties responsible for coverage and reimbursement of the product;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the availability of coverage and adequate reimbursement by third-party payors and government authorities;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the ability to manufacture our product in sufficient quantities and yields;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the strength and effectiveness of marketing and distribution support;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the prevalence and severity of any side effects;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">limitations or warnings, including distribution or use restrictions, contained in the product&#8217;s approved labeling or an approved REMS;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular infections;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the approval of other new products for the same indications;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the timing of market introduction of the approved product as well as competitive products;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the emergence of bacterial resistance to the product; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the rate at which resistance to other drugs in the target infections grow.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Any
failure by any of </FONT>our product candidates that obtains regulatory approval to achieve market acceptance or commercial success could
have a material adverse effect on our business 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 face substantial competition, which may result in others discovering,
developing, or commercializing products before or more successfully than we do.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
development and commercialization of new drug products is highly competitive. </FONT>We face competition from major multi-national pharmaceutical
companies, biotechnology companies, specialty pharmaceutical companies and generic drug companies with respect to our current and future
product candidates. There are several large pharmaceutical and biotechnology companies that currently market and sell products or are
pursuing the development of product candidates for the treatment of drug-resistant infections. Potential competitors also include academic
institutions, government agencies and other public and private research organizations. Our competitors may succeed in developing, acquiring
or licensing technologies and drug products that are more effective, more effectively marketed and sold or less costly than our product
candidates, which could render our product candidates non-competitive and 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
</FONT>our competitors obtain marketing approval from the FDA, the EMA or other comparable regulatory authorities for their product candidates
more rapidly than we do, it could result in our competitors establishing a strong market position before we are able to enter the market.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Many
of </FONT>such our competitors have greater financial resources and expertise in research and development, manufacturing, preclinical
testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do as an organization. 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 other 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 and management personnel, establishing clinical trial sites and patient registration 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">&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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,
have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop. Our
competitors also may obtain approval from the FDA, the EMA or other comparable regulatory agencies for their product candidates more rapidly
than we may obtain approval for ours, which could result in product approval delays if a competitor obtains market exclusivity from the
FDA or the EMA, or our competitors establish a strong market position before we are able to enter the market. In addition, our ability
to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic drugs. Additional
drugs may become available on a generic basis over the coming years. If our product candidates achieve marketing approval, we expect that
they will be priced at a significant premium over competitive generic drugs.</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>Coverage and adequate reimbursement may not be available for
our current or any future product candidates, which could make it difficult for us to sell profitably, if approved.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Market
acceptance and sales of any product candidates that </FONT>we or our collaborators commercialize will depend in part on the extent to
which reimbursement for these drugs and related treatments will be available from third-party payors, including government health care
programs (such as Medicare and Medicaid), government health administration authorities, managed care organizations and other private health
insurers. Third-party payors decide which therapies they will pay for and establish reimbursement levels. Third-party payors often rely
upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding
the extent of coverage and amount of reimbursement to be provided for any product candidates that we develop will be made on a payor-by-payor
basis. One payor&#8217;s determination to provide coverage for a drug does not assure that other payors will also provide coverage and
adequate reimbursement for the drug. Additionally, a third-party payor&#8217;s decision to provide coverage for a therapy does not imply
that an adequate reimbursement rate will be approved. Each payor determines whether it will provide coverage for a therapy, what amount
it will pay the manufacturer for the therapy, and on what tier of its list of covered drugs, or formulary, it will be placed. The position
on a payor&#8217;s formulary generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly
influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers
prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are
unlikely to use our drugs, and providers are unlikely to prescribe our drugs, unless coverage is provided, and reimbursement is adequate
to cover a significant portion of the cost of our drugs and their administration.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
primary trend in the United States healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control
costs by limiting coverage and the amount of reimbursement for particular medications. </FONT>We cannot be sure that coverage and reimbursement
will be available for any drug that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Inadequate
coverage and reimbursement may impact the demand, or the price of, any drug for which we obtain marketing approval for. If coverage and
adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our
current and any future product candidates that we develop.</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>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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
</FONT>face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and
will face an even greater risk if we commercially sell any drugs that we may develop. If we cannot successfully defend ourselves against
claims that our product candidates or products caused injuries, we will 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">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="width: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced resources of our management to pursue our business strategy;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">decreased demand for any product candidates or products that we may develop;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">injury to our reputation and significant negative media attention;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></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="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">withdrawal of clinical trial participants;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">initiation of investigations by regulators;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">product recalls, withdrawals or labeling, marketing or promotional restrictions;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">significant costs to defend the resulting litigation;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">substantial monetary awards paid to clinical trial participants or patients;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">loss of revenue; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the inability to commercialize any drugs that we may develop.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
currently hold product liability insurance coverage in an amount that may not be adequate to cover all liabilities that we may incur.
We may need to increase our insurance coverage as we expand our clinical trials or if we commence commercialization of our product candidates.
Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate
to satisfy any liability that may arise.</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 are a variety of risks associated with marketing our product
candidates internationally, which could affect 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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
or our collaborators may seek regulatory approval for our product candidates outside of the United States and, accordingly, we expect
that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">differing regulatory requirements in foreign countries;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market with low or lower prices rather than buying them locally;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">economic weakness, including inflation, or political instability in foreign economies and markets;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">foreign taxes, including withholding of payroll taxes;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">difficulties staffing and managing foreign operations;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">workforce uncertainty in countries where labor unrest is more common than in the United States;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">reduced level of reimbursement, pricing and insurance regimes compared to the United States;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></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="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods, fires, and public health epidemics, such as the COVID-19 pandemic.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">These
and other risks associated with </FONT>our international operations may compromise our ability to achieve or maintain 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>Risks Related to Our Business and Managing Our Growth</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>We might not be able to successfully integrate our operations
with those of Entasis and/or La Jolla and other assets that we may acquire.</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: 0.5in">We completed the acquisition of Entasis on July&nbsp;11,
2022, pursuant to which Entasis became a wholly owned subsidiary of Innoviva and the acquisition of La Jolla, on August&nbsp;22, 2022,
pursuant to which La Jolla became a wholly owned subsidiary of Innoviva. Our integration of the operations and personnel of each of Entasis
and La Jolla and any other assets we may acquire may require significant efforts, including significant amounts of management&#8217;s
time, and result in additional expenses. Factors that will affect the success of the acquisitions include the strength of our combined
product pipelines, our ability to execute our business strategy, our ability to adequately fund research and development and retain key
employees, and results of clinical trials, regulatory approvals and reimbursement levels of any approved product. In addition, we cannot
be certain that any technology or assets we acquire will be successfully developed, become profitable or remain so.</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 engage in future acquisitions or strategic collaborations,
this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject
us to other risks.</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: 0.5in">From time to time, we may evaluate various acquisitions
and strategic collaborations, including licensing or acquiring complementary drugs, intellectual property rights, technologies or businesses,
as deemed appropriate to carry out our business plan. Any potential acquisition or strategic collaboration may entail numerous risks,
including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">increased operating expenses and cash requirements;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the assumption of additional indebtedness or contingent liabilities;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">assimilation of operations, intellectual property and drugs of an acquired company, including challenges associated with integrating new personnel;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the diversion of our management&#8217;s attention from our existing drug programs and initiatives in pursuing such a strategic partnership, merger or acquisition;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing drugs or drug candidates and regulatory approvals; and</FONT></TD></TR>
</TABLE>

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<P STYLE="margin: 0"></P>

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    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">our inability to generate revenue from acquired technology and/or drugs sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.</FONT></TD></TR>
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<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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we are unable to obtain and maintain patent protection for
our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could
develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology
and product candidates may be adversely affected.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect
to our product candidates. We seek to protect our proprietary position by filing patent applications in the United States and abroad related
to our technology and product candidates. If we do not adequately protect our intellectual property, competitors may be able to use our
technologies and erode or negate any competitive advantage that we may have, which could harm our business and ability to achieve profitability.
To protect our proprietary positions, we file patent applications in the United States and abroad related to our novel technologies and
product candidates that are important to 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
patent application and prosecution process are expensive and time-consuming. We, </FONT>our current licensees, or any future licensors
and licensees may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely
manner. We or our current licensees, or any future licensors or licensees may also fail to identify patentable aspects of our research
and development before it is too late to obtain patent protection.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Therefore,
these and any of our patents and applications may not be prosecuted and enforced in a manner consistent with our best interests. It is
possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future,
such as with respect to proper priority claims, inventorship, claim scope or patent term adjustments. If our current licensees, or any
future licensors or licensees, are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any
patent rights, such patent rights could be compromised, and we might not be able to prevent third parties from making, using and selling
competing products. If there are material defects in the form or preparation of our patents or patent applications, such patents or applications
may be invalid and/or unenforceable. Moreover, </FONT>our competitors may independently develop equivalent knowledge, methods and know-how.
Any of these outcomes could impair our ability to prevent competition from third parties.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
patent position of biotechnology and pharmaceutical companies generally is highly uncertain. Changes in either the patent laws or interpretation
of the patent laws in the United States and other countries may diminish the value of </FONT>our patents or narrow the scope of our patent
protection. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United
States or in many foreign jurisdictions. For example, European patent law currently restricts the patentability of methods of treatment
of the human body more than United States law does. In addition, the determination of patent rights with respect to pharmaceutical compounds
and technologies commonly involves complex legal and factual questions, which has in recent years been the subject of much litigation.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Furthermore,
recent changes in patent laws in the United States, including the America Invents Act of 2011, may affect the scope, strength and enforceability
of our patent rights or the nature of proceedings that may be brought by us related to our patent rights.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We
</FONT>may not be aware of all third-party intellectual property rights potentially relating to our current and future product candidates.
Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United
States and other jurisdictions are typically not published until 18&#8239;months after filing, or in some cases not at all. Therefore,
we cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications, or that we were
the first to file for patent protection of such inventions. Similarly, should we own any patents or patent applications in the future,
we may not be certain that we were the first to file for patent protection for the inventions claimed in such patents or patent applications.
As a result, the issuance, scope, validity and commercial value of our patent rights cannot be predicted with any certainty. Moreover,
we may be subject to a third-party pre-issuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, or become involved
in derivation, ex-parte reexamination, or&nbsp;<I>inter partes</I>&nbsp;review proceedings in the USPTO or similar proceedings elsewhere,
challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation
could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates
and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing
third-party patent rights. If the breadth or strength of protection provided by our patents and patent applications is threatened, regardless
of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future 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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
pending and future patent applications may not result in patents being issued that protect our technology or product candidates, in whole
or in part, or which effectively prevent others from commercializing competitive technologies and products. Even if our patent applications
issue as patents, they may not issue in a form that will provide us with any meaningful protection against competing products or processes
sufficient to achieve our business objectives, prevent competitors from competing with us or otherwise provide us with any competitive
advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or
products in a non-infringing manner. Our competitors may seek to market generic versions of any approved products by submitting abbreviated
new drug applications to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable and/or not infringed.
Alternatively, our competitors may seek approval to market their own products similar to or otherwise competitive with our products. In
these circumstances, we may need to defend and/or assert our patents, including by filing lawsuits alleging patent infringement. In any
of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid and/or unenforceable.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and </FONT>our owned and licensed patents
may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or
freedom to operate, a patent being held unenforceable, and/or in one or more or in patent claims being narrowed or invalidated or held
unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology
and products or limit the duration of the patent protection of our technology and 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>Patent&nbsp;terms&nbsp;may be inadequate to protect our competitive
position on our product candidates for an adequate amount of time.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Patents
have a limited lifespan. In the U.S., if all maintenance fees are timely paid, the natural expiration of a patent is generally 20
years from its earliest filing date of a non-provisional application to which the patent claims priority. Various extensions may be
available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are
obtained, once the patent life has expired for a product candidate, </FONT>we may be open to competition from competitive
medications, including generic medications. Given the amount of time required for the development, testing and regulatory review of
new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are
commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others
from commercializing product candidates similar or identical to ours.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting
our candidates might expire before or shortly after our candidates are commercialized. Depending upon the timing, duration and conditions
of any FDA marketing approval of </FONT>our product candidates, one or more of our U.S. patents may be eligible for limited patent term
extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments, and similar
legislation in the European Union, as discussed above. As a result, our revenue from applicable products could be reduced. Further, if
this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical
data and launch their product earlier than might otherwise be the case, and our competitive position, business, financial condition, results
of operations, and prospects could be materially harmed.</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.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">A
third party may hold intellectual property rights, including patent rights, that are important or necessary to the development of </FONT>our
product candidates. 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. If we are unable to obtain such licenses
on commercially reasonable terms, our business could be harmed.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
</FONT>we are unable to obtain rights to required third-party intellectual property rights or maintain the existing intellectual property
rights we have, 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, we may be unable to develop or commercialize the affected technology and product candidates, which could
materially harm 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 become involved in lawsuits to protect or enforce our
patents or other 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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Competitors and other third parties may infringe
our issued patents, trademarks, copyrights or other intellectual property. To counter infringement or unauthorized use, we may be required
to file infringement claims, which can be expensive and time-consuming and divert the time and attention of our management and scientific
personnel. Any claims we assert against&nbsp;perceived infringers could provoke these parties to assert counterclaims against us alleging
that we infringe their patents, trademarks, copyrights or other intellectual property. In addition, in a patent infringement proceeding,
there is a risk that a court will decide that a patent of ours is invalid or unenforceable or that one or more claims of a patent are
invalid, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue. Grounds for
an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information
from the USPTO, or made a misleading statement, during prosecution. There is also a risk that, even if the validity of such patents is
upheld, the court will construe the patent&#8217;s claims narrowly or decide that we do not have the right to stop the other party from
using the invention at issue&nbsp;on the basis that&nbsp;our patents do not cover the invention. An adverse outcome in a litigation or
proceeding involving our patents could limit our ability to assert our patents against those parties or other&nbsp;competitors and&nbsp;may
curtail or preclude our ability to exclude third parties from making and selling similar or competitive products. Similarly, if we assert
trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against
whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced
to cease use of such trademarks.</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: 0.5in">In any infringement litigation, any award of monetary
damages we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required in connection
with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during
litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments
and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price
of our common stock. Moreover, there can be no assurance that we will have&nbsp;sufficient&nbsp;financial or other resources to file and
pursue such infringement claims, which typically last for&nbsp;years before they are concluded. Some of our competitors may be able to
sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources and more
mature and developed intellectual property portfolios. Even if we ultimately prevail in such claims, the monetary cost of such litigation
and the diversion of the attention of our management and scientific personnel could outweigh any benefit we receive&nbsp;because of&nbsp;the
proceedings. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or successfully
challenging our intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other
proceedings could have a negative impact on our ability to compete in the marketplace.</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>Third parties may initiate legal proceedings alleging that we
are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm 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: 0.5in">There is a substantial amount of intellectual
property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigation
or other adversarial proceedings regarding intellectual property rights with respect to our technology or product candidates,
including interference proceedings before the USPTO. Intellectual property disputes arise in&nbsp;several&nbsp;areas including with
respect to patents, use of other proprietary rights and the contractual terms of license arrangements. Third parties may assert
claims against us based on existing or future intellectual property rights. The outcome of intellectual property litigation is
subject to uncertainties that cannot be adequately quantified in advance.</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: 0.5in">If we are found to infringe a third-party&#8217;s
intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the
infringing product candidate or product. Alternatively, we may be required to obtain a license from such third party&nbsp;to&nbsp;use
the infringing technology and continue developing, manufacturing or marketing the infringing product candidate. However, we may not be
able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be
non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, we could be found liable for
monetary damages, including treble damages and attorneys&#8217; fees if we are found to have willfully infringed a patent. A finding of
infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations. Claims
that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative 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>We may not be able to protect our intellectual property rights
throughout the world.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Filing,
prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and </FONT>our
intellectual property rights in some countries outside the United States could be less extensive than those in the United States. In some
cases, we may not be able to obtain patent protection for certain licensed technology outside the United States. In addition, the laws
of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States,
even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing
our inventions in all countries outside the United States, even in jurisdictions where we do pursue patent protection or from selling
or importing products made using our inventions in and into the United States or other jurisdictions. Consequently, we may not be able
to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products
made using our inventions in and into the United States or other jurisdictions.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Competitors
may use </FONT>our technologies in jurisdictions where we have not pursued and obtained patent protection to develop their own products
and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong
as that in the United States. These products may compete with our product candidates and preclinical programs and our patents or other
intellectual property rights may not be effective or sufficient to prevent them from competing.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Many
companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets
and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for </FONT>us
to stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary rights
generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts
and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent
applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that
we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop or license.</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>If we are unable to protect the confidentiality of our trade
secrets, our business and competitive position would be harmed.</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: 0.5in">In addition to seeking patent and trademark protection
for our product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information,
to maintain our competitive position. We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality
agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract
manufacturers, consultants, advisors and other third parties prior to beginning research or disclosing proprietary information. We also
enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any
of these parties may breach the agreements and disclose our proprietary information, including our trade secrets. Despite these efforts
and the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information
due to our reliance on third parties, increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated
into the technology of others, or are disclosed or used in violation of these agreements.</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: 0.5in">Monitoring unauthorized uses and disclosures of
our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be
effective. In addition, we may not be able to obtain adequate remedies for any such breaches. Enforcing a claim that a party illegally
disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition,
some courts inside and outside the United States are less willing or unwilling to protect trade secrets.</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: 0.5in">Moreover, our competitors may independently develop
knowledge, methods and know-how equivalent to our trade secrets. Competitors could purchase our products and replicate some or&nbsp;all&nbsp;the
competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any of our
trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those
to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed
to or independently developed by a competitor, our competitive position would be harmed.</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 Regulatory Approval of Our Product Candidates and
Other Legal Compliance Matters</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>Even if we complete the necessary preclinical studies and clinical
trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us or any future collaborators from
obtaining approvals for the commercialization of some or all of our product candidates. As a result, we cannot predict when or if, and
in which territories, we, or any future collaborators, will obtain marketing approval to commercialize a product candidate.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our
</FONT>product candidates and the activities associated with their development and commercialization, including their design, research,
testing, manufacture, safety, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, advertising, promotion,
sale, distribution, import, export, and reporting of safety and other post-market information, are subject to comprehensive regulation
by the FDA, the EMA and other foreign regulatory agencies. Failure to obtain marketing approval for a product candidate will prevent us
or a potential collaborator from commercializing the product candidate. We will rely on third parties to assist us in the process of filing
and supporting the applications necessary to gain marketing approvals. Securing marketing approval requires the submission of extensive
preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product
candidate&#8217;s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing
process to, and inspection of manufacturing facilities by, the regulatory authorities. Our product candidates may not be effective, may
be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may
preclude our obtaining marketing approval or prevent or limit commercial use. We may not be able to successfully manufacture our products
in compliance with applicable requirements such as GMPs. If any of our product candidates receives marketing approval, the accompanying
label may limit its approved use more narrowly than we anticipate, which could limit sales of the product.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years, if approval is obtained
at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates
involved. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to
regulatory authorities for each therapeutic indication to establish the product candidate&#8217;s safety and efficacy. Securing marketing
approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities
by, the regulatory authorities. The FDA, the EMA or other regulatory authorities may determine that </FONT>our product candidates are
not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics
that preclude us from obtaining marketing approval or prevent or limit commercial use. Any marketing approval we ultimately obtain may
be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
addition, changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or
regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of
an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or
may decide that </FONT>our data is insufficient for approval and require additional preclinical, clinical or other studies. In addition,
varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of
a product candidate. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments
that render the approved product not commercially viable. Any marketing approval that we, or any future collaborators, ultimately obtain
may be limited or subject to restrictions or post-approval commitments that render the approved product not commercially viable.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">If
</FONT>we experience delays in obtaining approval or if we fail to obtain approval of our product candidates, the commercial prospects
for our product candidates may be harmed and our ability to generate revenues will be impaired.</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>Failure to obtain marketing approval in foreign jurisdictions
would prevent certain of our product candidates from being marketed in these territories. Any approval we are granted for our product
candidates in the United States would not assure approval of our product candidates in foreign 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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">To
market and sell our products in the European Union, or EU, and any other jurisdictions, </FONT>we must obtain separate marketing approvals
and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional
testing. The time required to obtain approval may differ substantially from that required to obtain approval from the FDA. The regulatory
approval process outside the United States generally includes all the risks associated with obtaining approval from the FDA. In addition,
in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved
for sale in that country. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.
Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory
authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
However, denial of approval in one jurisdiction may impact the ability to obtain approval elsewhere. We may not be able to file for marketing
approvals and 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">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if we obtain marketing approvals for our product candidates,
the terms of approvals and ongoing regulation of our products may limit how we or our collaborators manufacture and market our products
and compliance with such requirements may involve substantial resources, which could materially impair our ability to generate revenue.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Even
if marketing approval of a product candidate is granted, an approved product and its manufacturer and marketer are subject to ongoing
review and extensive regulation, including the potential requirements to implement a REMS or to conduct costly post-marketing studies
or clinical trials and surveillance to monitor the safety or efficacy of the product. </FONT>We must also comply with requirements concerning
advertising and promotion for any of our product candidates for which we obtain marketing approval. Promotional communications with respect
to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the
product&#8217;s approved labeling. Thus, we will not be able to promote any products we develop for indications or uses for which they
are not approved. In addition, manufacturers of approved products and those manufacturers&#8217; facilities are required to comply with
extensive FDA requirements including ensuring that quality control and manufacturing procedures conform to cGMP, which include requirements
relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation and reporting
requirements, among other things. We and our contract manufacturers could be subject to periodic unannounced inspections by the FDA to
monitor and ensure compliance with cGMP. We must also comply with FDA requirements for adverse event reporting for commercial 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"></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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Accordingly,
assuming we receive marketing approval for one or more of our product candidates, </FONT>we and our contract manufacturers will continue
to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and
quality control. If we are not able to comply with post-approval regulatory requirements, we could have the marketing approvals for our
products withdrawn by regulatory authorities and our ability to market any future products could be limited, which could adversely affect
our ability to achieve or sustain profitability. We could also be subject to other civil or criminal penalties. Thus, the cost of compliance
with post-approval regulations may have a negative effect on our operating results and 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; text-indent: 0.5in"><B><I>Any product candidate for which we obtain
marketing approval could be subject to post-marketing restrictions or recall 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 product candidates, when and if
any of them are approved.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA and other federal and state agencies, including the U.S. DOJ, closely regulate compliance with all requirements governing prescription
drug products, including requirements pertaining to marketing and promotion of drugs in accordance with the provisions of the approved
labeling and manufacturing of products in accordance with cGMP requirements. The FDA and DOJ impose stringent restrictions on manufacturers&#8217;
communications regarding off-label use and if </FONT>we market our products for indications other than their approved indications, we
may be subject to enforcement action for off-label marketing. Violations of such requirements may lead to investigations alleging violations
of the Food, Drug and Cosmetic Act and other statutes, including the False Claims Act and other federal and state health care fraud and
abuse laws as well as state consumer protection laws.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with our
products, manufacturers or manufacturing processes, may yield various results, including:</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: 3%; padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">litigation involving patients taking our products;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">restrictions on our products, manufacturers or manufacturing processes;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">restrictions on the labeling or marketing of a product;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">restrictions on product distribution or use;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">requirements to conduct post-marketing studies or clinical trials;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">warning or untitled letters;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">withdrawal of the products from the market;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">refusal to approve pending applications or supplements to approved applications that we submit;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">recall of products;</FONT></TD></TR>
</TABLE>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

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<P STYLE="margin: 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR>
    <TD STYLE="padding: 0.75pt; width: 3%">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt; width: 2%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">fines, restitution or disgorgement of profits or revenues;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">suspension or withdrawal of marketing approvals;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">damage to relationships with any potential collaborators;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">unfavorable press coverage and damage to our reputation;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">refusal to permit the import or export of our products;</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">product seizure; or</FONT></TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="font-size: 10pt">&nbsp;</TD></TR>
  <TR>
    <TD STYLE="padding: 0.75pt">&nbsp;</TD>
    <TD STYLE="white-space: nowrap; vertical-align: top; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">injunctions or the imposition of civil or criminal penalties.</FONT></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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Non-compliance
by </FONT>us or any future collaborator with regulatory requirements regarding safety monitoring or pharmacovigilance, and with requirements
related to the development of products for the pediatric population, can also result in significant financial penalties. Similarly, failure
to comply with regulatory requirements regarding the protection of personal information can also lead to significant penalties and sanctions.</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: 0.5in">Non-compliance with U.K. and EU requirements regarding
safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population, also
can result in significant financial penalties. Similarly, failure to comply with the U.K.&#8217;s or EU&#8217;s requirements regarding
the protection of personal information can also lead to significant penalties and sanctions.</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 current and future relationships with healthcare professionals,
principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject, directly or
indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and
security and other healthcare laws and regulations, which could expose us to penalties.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Our</FONT>
current and future arrangements with healthcare professionals, principal investigators, consultants, customers and third-party payors
may expose us to broadly applicable fraud and abuse and other healthcare laws, including, without limitation, the federal Anti-Kickback
Statute and the federal False Claims Act, that may constrain the business or financial arrangements and relationships through which we
research, sell, market and distribute any product candidates for which we obtain marketing approval. In addition, we may be subject to
physician payment transparency laws and patient privacy and security regulation by the federal government and by the states and foreign
jurisdictions in which we conduct our business. The applicable federal, state and foreign healthcare laws that may affect our ability
to operate include the following:</P>

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

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    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid;</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="white-space: nowrap; vertical-align: top; width: 2%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9679;</FONT></TD>
    <TD STYLE="width: 95%; font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including through civil whistleblower or&nbsp;<I>qui tam</I>&nbsp;actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;</FONT></TD></TR>
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"></P>

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    <TD STYLE="font-size: 10pt; width: 95%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">HIPAA, which created additional federal criminal and civil statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of whether the payor is public or private, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">HIPAA, as amended by the HITECH Act of 2009, and their respective implementing regulations, which impose obligations on &#8220;covered entities,&#8221; including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective &#8220;business associates&#8221; that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">the federal Physician Payments Sunshine Act, created under Section&#8239;6002 of Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, and its implementing regulations, which created annual reporting requirements for manufacturers of drugs, devices, biologicals and medical supplies for certain payments and &#8220;transfers of value&#8221; provided to covered recipients, including physicians, as defined by such law, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and</FONT></TD></TR>
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    <TD STYLE="font-size: 10pt"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry&#8217;s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or to adopt compliance programs as prescribed by state laws and regulations, or that otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and drug pricing; state and local laws requiring the licensure of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">Further, the ACA, among other things, amended the
intent requirement of the federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud. A person or entity no
longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the ACA provided that the government
may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false
or fraudulent claim for purposes of the False Claims Act.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Efforts
to ensure that </FONT>our future business arrangements with third parties will comply with applicable healthcare laws and regulations
may involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with
current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws. If our operations are
found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant
civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, disgorgement, possible exclusion
from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits
and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement
to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, any of which could adversely
affect our ability to operate our business and pursue our strategy. If any of the physicians or other healthcare providers or entities
with whom we expect to do business, including future collaborators, are found not to be in compliance with applicable laws, they may be
subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which
could also affect 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>Future legislation, and/or regulations and policies adopted by
the FDA, the EMA or comparable regulatory authorities, may increase the time and cost required for us or our collaborators to conduct
and complete clinical trials of our current and future product candidates.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">The
FDA and the EMA have each established regulations to govern the product development and approval process, as have other foreign regulatory
authorities. The policies of the FDA, the EMA and other regulatory authorities may change. For example, in December&#8239;2016, the 21st&#8239;Century
Cures Act, or Cures Act, was signed into law. The Cures Act, among other things, is intended to modernize the regulation of drugs and
spur innovation, but not all its provisions have yet been implemented. Additionally, in August&#8239;2017, the FDA issued final guidance
setting forth its current thinking with respect to development programs and clinical trial designs for antibacterial drugs to treat serious
bacterial diseases in patients with an unmet medical need. </FONT>We cannot predict what if any effect the Cures Act or any existing or
future guidance from the FDA or other regulatory authorities will have on the development of our 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>Recently enacted and future legislation, including relevant provisions
of the Inflation Reduction Act, may increase the difficulty and cost for us and our collaborators to obtain marketing approval of and
commercialize our product candidates and affect the prices we may obtain.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">In
the United States and some foreign jurisdictions, there have been several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities
and affect </FONT>our ability to profitably sell any product candidates for which we obtain marketing approval.</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: 0.5in">Among policy makers and payors in the United States
and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare
costs, improving quality and/or expanding access.</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: 0.5in">Other federal health reform measures have been
proposed and adopted in the United States. For example, the Medicare Access and CHIP Reauthorization Act of 2015 ended the use of the
statutory formula for clinician payment and established a quality payment incentive program, also referred to as the Quality Payment Program.
This program provides clinicians with two ways to participate, including through the Advanced Alternative Payment Models, or APMs, and
the Merit-based Incentive Payment System, or MIPS. In November&nbsp;2019, CMS issued a final rule&nbsp;finalizing the changes to the Quality
Payment Program. It is unclear how payment reductions or the introduction of the Quality Payment Program will impact overall physician
reimbursement under the Medicare program. It is also unclear if changes in Medicare payments to providers would impact such providers&#8217;
willingness to prescribe and administer our products, if approved.</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: 0.5in">Further, there has been heightened governmental
scrutiny over the way companies set prices for their marketed products. For example, there have been several recent 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 patient programs, and reform government program reimbursement methodologies for drug products. In
particular, the recently passed Inflation Reduction Act contains provisions designed to limit the prices paid by Medicare for various
prescription drugs.</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: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">We</FONT>
expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage
criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from
Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment
measures or other healthcare reforms may prevent us or our collaborators from being able to generate revenue, attain profitability, or
commercialize our drugs.</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; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">Legislative
and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for drugs.
</FONT>We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations
will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. In addition,
increased scrutiny by the U.S. Congress of the FDA&#8217;s approval process may significantly delay or prevent marketing approval, as
well as subject us to more stringent product labeling and post-marketing testing and other 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"><B><I>Our product candidates may be subject to government price controls
that may affect our revenue.</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: 0.5in">There has been heightened governmental scrutiny
in the United States and abroad of pharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. In
the United States, such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal legislation designed
to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs,
and reform government program reimbursement methodologies for products. At the federal level, the former Trump Administration&#8217;s
budget proposal for fiscal year 2020 contained further drug price control measures that could be enacted during the 2020 budget process
or in other future legislation, including, for example, measures to permit Medicare Part&#8239;D plans to negotiate the price of certain
drugs under Medicare Part&#8239;B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic
drugs for low-income patients. The former Trump Administration also released a &#8220;Blueprint&#8221;, or plan, to lower drug prices
and reduce out-of-pocket costs of drugs that contains additional proposals to increase drug 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.</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: 0.5in">HHS has solicited feedback on some of these measures
and has implemented others under its existing authority. For example, in May&nbsp;2019, CMS issued a final rule&nbsp;to allow Medicare
Advantage plans the option to use step therapy for Part&nbsp;B drugs beginning January&nbsp;1, 2020. This final rule&nbsp;codified CMS&#8217;s
policy change that was effective January&nbsp;1, 2019. On November&nbsp;20, 2020, CMS issued an<B>&nbsp;</B>interim final rule&nbsp;through
the CMS Innovation Center whereby Medicare Part&nbsp;B reimbursement for &#8220;certain high-cost prescriptions drugs&#8221; would be
no more than most-favored-nation price (i.e., the lowest price) after adjustments, for a pharmaceutical product that the drug manufacturer
sells in a member country&nbsp;of the Organization for Economic Cooperation and Development that has a comparable per-capita gross domestic
product. On December&nbsp;28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction
against implementation of the interim final rule. While some of these and other measures may require additional authorization to become
effective, members of Congress and the new Biden Administration have indicated that they will continue to seek new legislative and/or
administrative measures to control drug costs. For example, the recently enacted Inflation Reduction Act contains provisions designed
to limit the prices paid by Medicare for various prescription drugs. At the state level, legislatures 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, in some cases, designed to encourage importation from other countries and bulk purchasing.</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: 0.5in">Outside of the United States, particularly in the
European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations
with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain coverage and
reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness
of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount,
or if pricing is set at unsatisfactory levels, our business could be harmed.</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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      <link:label xlink:type="resource" xlink:role="http://www.xbrl.org/2003/role/label" xlink:label="dei_Security12gTitle_lbl" xml:lang="en-US">Title of 12(g) Security</link:label>
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</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-101.PRE
<SEQUENCE>5
<FILENAME>inva-20220823_pre.xml
<DESCRIPTION>XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
<TEXT>
<XBRL>
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<head>
<title></title>
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<span style="display: none;">v3.22.2.2</span><table class="report" border="0" cellspacing="2" id="idm139787495478224">
<tr>
<th class="tl" colspan="1" rowspan="1"><div style="width: 200px;"><strong>Cover<br></strong></div></th>
<th class="th"><div>Aug. 23, 2022</div></th>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CoverAbstract', window );"><strong>Cover [Abstract]</strong></a></td>
<td class="text">&#160;<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentType', window );">Document Type</a></td>
<td class="text">8-K<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_AmendmentFlag', window );">Amendment Flag</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_DocumentPeriodEndDate', window );">Document Period End Date</a></td>
<td class="text">Aug. 23,  2022<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityFileNumber', window );">Entity File Number</a></td>
<td class="text">000-30319<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityRegistrantName', window );">Entity Registrant Name</a></td>
<td class="text">INNOVIVA, INC.<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityCentralIndexKey', window );">Entity Central Index Key</a></td>
<td class="text">0001080014<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityTaxIdentificationNumber', window );">Entity Tax Identification Number</a></td>
<td class="text">94-3265960<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityIncorporationStateCountryCode', window );">Entity Incorporation, State or Country Code</a></td>
<td class="text">DE<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressAddressLine1', window );">Entity Address, Address Line One</a></td>
<td class="text">1350 Bayshore Highway<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressAddressLine2', window );">Entity Address, Address Line Two</a></td>
<td class="text">Suite 400<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressCityOrTown', window );">Entity Address, City or Town</a></td>
<td class="text">Burlingame<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressStateOrProvince', window );">Entity Address, State or Province</a></td>
<td class="text">CA<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityAddressPostalZipCode', window );">Entity Address, Postal Zip Code</a></td>
<td class="text">94010<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_CityAreaCode', window );">City Area Code</a></td>
<td class="text">650<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_LocalPhoneNumber', window );">Local Phone Number</a></td>
<td class="text">238-9600<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_WrittenCommunications', window );">Written Communications</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SolicitingMaterial', window );">Soliciting Material</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementTenderOffer', window );">Pre-commencement Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_PreCommencementIssuerTenderOffer', window );">Pre-commencement Issuer Tender Offer</a></td>
<td class="text">false<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_Security12bTitle', window );">Title of 12(b) Security</a></td>
<td class="text">Common Stock, par value $0.01 per share<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_TradingSymbol', window );">Trading Symbol</a></td>
<td class="text">INVA<span></span>
</td>
</tr>
<tr class="re">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_SecurityExchangeName', window );">Security Exchange Name</a></td>
<td class="text">NASDAQ<span></span>
</td>
</tr>
<tr class="ro">
<td class="pl" style="border-bottom: 0px;" valign="top"><a class="a" href="javascript:void(0);" onclick="Show.showAR( this, 'defref_dei_EntityEmergingGrowthCompany', window );">Entity Emerging Growth Company</a></td>
<td class="text">false<span></span>
</td>
</tr>
</table>
<div style="display: none;">
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_AmendmentFlag">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_AmendmentFlag</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CityAreaCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Area code of city</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CityAreaCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_CoverAbstract">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Cover page.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_CoverAbstract</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:stringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentPeriodEndDate">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period.  The format of the date is YYYY-MM-DD.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentPeriodEndDate</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:dateItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_DocumentType">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_DocumentType</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:submissionTypeItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressAddressLine1">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Address Line 1 such as Attn, Building Name, Street Name</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressAddressLine1</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressAddressLine2">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Address Line 2 such as Street or Suite number</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressAddressLine2</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressCityOrTown">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the City or Town</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressCityOrTown</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressPostalZipCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Code for the postal or zip code</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressPostalZipCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityAddressStateOrProvince">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the state or province.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityAddressStateOrProvince</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:stateOrProvinceItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityCentralIndexKey">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityCentralIndexKey</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:centralIndexKeyItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityEmergingGrowthCompany">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Indicate if registrant meets the emerging growth company criteria.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityEmergingGrowthCompany</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:booleanItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityFileNumber">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityFileNumber</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:fileNumberItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityIncorporationStateCountryCode">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Two-character EDGAR code representing the state or country of incorporation.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityIncorporationStateCountryCode</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>dei:edgarStateCountryItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
</tr>
<tr>
<td><strong> Period Type:</strong></td>
<td>duration</td>
</tr>
</table></div>
</div></td></tr>
</table>
<table border="0" cellpadding="0" cellspacing="0" class="authRefData" style="display: none;" id="defref_dei_EntityRegistrantName">
<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
<tr><td><div class="body" style="padding: 2px;">
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_EntityRegistrantName</td>
</tr>
<tr>
<td style="padding-right: 4px;white-space:nowrap;"><strong> Namespace Prefix:</strong></td>
<td>dei_</td>
</tr>
<tr>
<td><strong> Data Type:</strong></td>
<td>xbrli:normalizedStringItemType</td>
</tr>
<tr>
<td><strong> Balance Type:</strong></td>
<td>na</td>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b-2<br></p></div>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Local phone number for entity.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 13e<br> -Subsection 4c<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
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<tr><td class="hide"><a style="color: white;" href="javascript:void(0);" onclick="Show.hideAR();">X</a></td></tr>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 14d<br> -Subsection 2b<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Title of a 12(b) registered security.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection b<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Name of the Exchange on which a security is registered.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Number 240<br> -Section 12<br> -Subsection d1-1<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
<tr>
<td><strong> Name:</strong></td>
<td style="white-space:nowrap;">dei_SecurityExchangeName</td>
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Exchange Act<br> -Section 14a<br> -Number 240<br> -Subsection 12<br></p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Trading symbol of an instrument as listed on an exchange.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>No definition available.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ Details</a><div style="display: none;"><table border="0" cellpadding="0" cellspacing="0">
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<a href="javascript:void(0);" onclick="Show.toggleNext( this );">- Definition</a><div><p>Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.</p></div>
<a href="javascript:void(0);" onclick="Show.toggleNext( this );">+ References</a><div style="display: none;"><p>Reference 1: http://www.xbrl.org/2003/role/presentationRef<br> -Publisher SEC<br> -Name Securities Act<br> -Number 230<br> -Section 425<br></p></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
