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  <P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>As filed with the Securities and Exchange Commission on June 24,
  2022</B></P>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Registration No. 333-______________</B></P>
  
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  <!-- Field: Rule-Page --><DIV STYLE="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>UNITED STATES</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>SECURITIES AND
  EXCHANGE COMMISSION</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C. 20549</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>FORM S-8</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REGISTRATION STATEMENT UNDER THE SECURITIES
  ACT OF 1933</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><FONT STYLE="font-size: 18pt"><B>Blue Water Vaccines
  Inc.</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Exact name of registrant as specified in charter)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>Delaware</B></TD>
      <TD STYLE="width: 2%; padding-bottom: 1.75pt; font-size: 10pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>81-2262816</B></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="font-size: 10pt; text-align: center">(State or Other Jurisdiction of<BR>
  Incorporation or Organization)</TD>
      <TD STYLE="font-size: 10pt; text-align: center">&nbsp;</TD>
      <TD>
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(IRS Employer</P>
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Identification No.)</P></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 49%; border-bottom: black 1.5pt solid">
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>201 E. Fifth Street, Suite 1900</B></P>
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Cincinnati, OH</B></P></TD>
      <TD STYLE="width: 2%; padding-bottom: 1.75pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; text-align: center"><B>45202</B></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: center">(Address of Principal Executive Offices)</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">(Zip Code)</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 100%; border-bottom: black 1.5pt solid">
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Blue Water Vaccines Inc. 2019 Equity
      Incentive Plan</B></P>
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Blue Water Vaccines Inc. 2022 Equity
      Incentive Plan</B></P></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="font-size: 10pt; text-align: center">(Full Title of the Plan)</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Joseph Hernandez</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Chief Executive Officer</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Blue Water Vaccines Inc.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>201 E. Fifth Street, Suite 1900</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><U>Cincinnati, OH 45202</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Name and Address of Agent For Service)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><U>(513) 620-4101</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">Telephone Number, Including Area Code of Agent
  For Service.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Copy to:</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Barry I. Grossman, Esq.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Jessica Yuan, Esq.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Ellenoff Grossman &amp; Schole LLP</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>1345 Avenue of the Americas, 11th Floor</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>New York, New York 10105</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Telephone: (212) 370-1300</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Facsimile: (212) 370-7889</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">Indicate by check mark whether the registrant
  is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
  See the definitions of &ldquo;large accelerated filer,&rdquo; &ldquo;accelerated filer,&rdquo; &ldquo;smaller reporting company&rdquo;
  and &ldquo;emerging growth company&rdquo; in Rule 12b-2 of the Exchange Act. (Check one):</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
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    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 29%; padding-right: 0.65pt">Large accelerated filer</TD>
      <TD STYLE="width: 15%; padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></TD>
      <TD STYLE="width: 1%; padding-right: 1.05pt">&nbsp;</TD>
      <TD STYLE="width: 40%; padding-right: 0.65pt">Accelerated filer</TD>
      <TD STYLE="width: 15%; padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 0.65pt">Non-accelerated filer</TD>
      <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD>
      <TD STYLE="padding-right: 1.05pt">&nbsp;</TD>
      <TD STYLE="padding-right: 0.65pt">Smaller reporting company</TD>
      <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD COLSPAN="2" STYLE="padding-right: 0.85pt">&nbsp;</TD>
      <TD STYLE="padding-right: 0.65pt">&nbsp;</TD>
      <TD STYLE="padding-right: 0.65pt">Emerging growth company</TD>
      <TD STYLE="padding-right: 1.05pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9746;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">If an emerging growth company, indicate by check
  mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
  standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. <FONT STYLE="font-family: Times New Roman, Times, Serif">&#9744;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Explanatory Note</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">This Registration Statement
  is being filed by the Registrant relating to 780,640 shares of our common stock which may be offered and sold pursuant to our 2019 Equity
  Incentive Plan (the &ldquo;2019 Plan&rdquo;) and 819,360 shares of our common stock, par value $0.0001 per share (the &ldquo;Common Stock&rdquo;)
  which may be offered and sold pursuant to our 2022 Equity Incentive Plan (the &ldquo;2022 Plan&rdquo;).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">This Registration Statement
  includes, pursuant to General Instruction C to Form S-8, a re-offer prospectus in Part I (the &ldquo;Reoffer Prospectus&rdquo;). The Reoffer
  Prospectus may be utilized for reofferings and resales by certain employees, executive officers and directors listed in the Reoffer Prospectus
  who may be deemed &ldquo;affiliates&rdquo; of the Company on a continuous or a delayed basis in the future of up to 1,600,000 shares of
  Common Stock. These shares constitute &ldquo;control securities&rdquo; or &ldquo;restricted securities&rdquo; within the meaning of the&nbsp;Securities
  Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), and the rules and regulations promulgated thereunder, which have been issued
  prior to or issuable after the filing of this Registration Statement. The Reoffer Prospectus does not contain all of the information included
  in the Registration Statement, certain items of which are contained in schedules and exhibits to the Registration Statement, as permitted
  by the rules and regulations of the SEC. Statements contained in this Reoffer Prospectus as to the contents of any agreement, instrument
  or other document referred to are not necessarily complete. With respect to each such agreement, instrument or other document filed as
  an exhibit to the Registration Statement, we refer you to the exhibit for a more complete description of the matter involved, and each
  such statement shall be deemed qualified in its entirety by this reference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">As specified in General Instruction
  C of Form S-8, until such time as we meet the registrant requirements for use of Form S-3, the number of shares of Common Stock to be
  offered by means of the Reoffer Prospectus, by each of the selling security holders, and any other person with whom he or she is acting
  in concert for the purpose of selling our shares of Common Stock, may not exceed, during any three month period, the amount specified
  in Rule&nbsp;144(e)&nbsp;of the&nbsp;Securities Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PART I</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Blue Water Vaccines Inc.,
  a Delaware corporation (the &ldquo;Company&rdquo;, &ldquo;us&rdquo;, &ldquo;our&rdquo; or &ldquo;we&rdquo;), has prepared this Registration
  Statement on Form S-8 (the &ldquo;Registration Statement&rdquo;) in accordance with the requirements of Form S-8 under the Securities
  Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), to register 1,600,000 shares of our common stock, par value $0.00001 per share
  (the &ldquo;Common Stock&rdquo;), which may be offered and sold pursuant to the 2019 Plan and the 2022 Plan and to file a prospectus,
  prepared in accordance with the requirements of Part I of Form S-3 and, pursuant to General Instruction C of Form S-8, to be used for
  reoffers and resales of Common Stock acquired by persons to be named therein upon the exercise of options and restricted stock awards
  granted under the 2019 Plan and the 2022 Plan.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Pursuant to the Note to Part
  I on Form S-8, the documents containing the information specified in Part I of this Registration Statement will be sent or given to plan
  participants as specified by Rule 428(b)(1) of the Securities Act. Such documents are not required to be filed, and are not filed, with
  the United States Securities and Exchange Commission either as part of this Registration Statement or as prospectuses or prospectus supplements
  pursuant to Rule 424 of the Securities Act. These documents and the documents incorporated by reference in this Registration Statement
  pursuant to Item 3 of Part II of this Form S-8, taken together, constitute a prospectus that meets the requirements of Section 10(a) of
  the Securities Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>REOFFER PROSPECTUS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B>Blue Water Vaccines
  Inc.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left; background-color: white"><B>Up to 1,600,000 shares
  of Common Stock under the 2019 Equity Incentive Plan and 2022 Equity Incentive Plan</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">This
  prospectus relates to the resale of up to 1,600,000 shares (the &ldquo;Shares&rdquo;) of common stock, par value $0.00001 per share (the
  &ldquo;Common Stock&rdquo;), of Blue Water Vaccines Inc., a Delaware corporation (the &ldquo;Company&rdquo;, &ldquo;us&rdquo;, &ldquo;our&rdquo;
  or &ldquo;we&rdquo;), which may be offered and sold from time to time by certain stockholders of the Company (the &ldquo;Selling Stockholders&rdquo;)
  who have acquired or will acquire such Shares in connection with the exercise of stock options granted, and with stock or other awards
  made, and with the purchase of stock under, the 2019 Plan or the 2022 Plan. The 2019 Plan and the 2022 Plan are intended to provide incentives
  which will attract, retain, and motivate highly competent persons such as officers, employees, directors, and consultants to our Company
  by providing them opportunities to acquire shares of our Common Stock. Additionally, the 2019 Plan and the 2022 Plan are intended to assist
  in further aligning the interests of our officers, employees, directors and consultants to those of the Company&rsquo;s other stockholders.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">The persons who are issued such Shares may include our directors, officers,
  employees and consultants, certain of whom may be considered our &ldquo;affiliates&rdquo;. Such persons may, but are not required to,
  sell the Shares they acquire pursuant to this prospectus. If any additional awards are issued to or Shares are purchased by affiliates
  under the 2019 Plan or the 2022 Plan, we will file with the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) an update
  to this prospectus naming such person as a selling shareholder and indicating the number of shares such person is offering pursuant to
  the prospectus. See &ldquo;Selling Stockholders&rdquo; on page 106 of this prospectus. Our Common Stock is listed on The Nasdaq Capital
  Market under the symbol &ldquo;BWV.&rdquo; On June 17, 2022, the closing price of the Common Stock on The Nasdaq Capital Market was $2.50
  per share.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Our shares of common stock have experienced extreme volatility in market
  prices and trading volume since listing. From February 18, 2022 (the date our shares were initially listed on Nasdaq) to the date hereof,
  the market price of our common stock has fluctuated from an intra-day low on Nasdaq of $2.46 on June 17, 2022 to an intra-day high of
  $90.90 per share on February 22, 2022. By comparison, our initial public offering, which closed on February 23, 2022, was conducted at
  $9.00 per share. During this time, we have made one announcement regarding certain research developments for our vaccine candidates. Notwithstanding
  the foregoing, since our initial public offering on February 18, 2022, there were no material recent publicly disclosed changes in the
  financial condition or results of operations of the Company, such as our earnings or revenue, that are consistent with or related to the
  changes in our stock price. The trading price of our common stock has been, and may continue to be, subject to wide price fluctuations
  in response to various factors, many of which are beyond our control, including those described under the heading &ldquo;Risk Factors&rdquo;
  beginning on page 63 of this prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">We
  will not receive any of the proceeds from sales of the Shares by any of the Selling Stockholders. The Shares may be offered from time
  to time by any or all of the Selling Stockholders through ordinary brokerage transactions, in negotiated transactions or in other transactions,
  at such prices as such Selling Stockholder may determine, which may relate to market prices prevailing at the time of sale or be a negotiated
  price. See &ldquo;Plan of Distribution.&rdquo; Sales may be made through brokers or to dealers, who are expected to receive customary
  commissions or discounts. We are paying all expenses of registration incurred in connection with this offering but the Selling Stockholders
  will pay all brokerage commissions and other selling expenses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">The
  Selling Stockholders and participating brokers and dealers may be deemed to be &ldquo;underwriters&rdquo; within the meaning of the Securities
  Act, in which event any profit on the sale of shares of those Selling Stockholders and any commissions or discounts received by those
  brokers or dealers may be deemed to be underwriting compensation under the Securities Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">SEE
  &ldquo;RISK FACTORS&rdquo; BEGINNING ON PAGE 63 OF THIS PROSPECTUS FOR A DISCUSSION OF CERTAIN RISKS AND OTHER FACTORS THAT YOU SHOULD
  CONSIDER BEFORE PURCHASING OUR COMMON STOCK.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">Neither
  the Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is
  truthful or complete. Any representation to the contrary is a criminal offense.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">The date of this prospectus
  is June 24, 2022.</P>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>TABLE OF CONTENTS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom; background-color: white">
      <TD STYLE="width: 90%">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center">Page No</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_001">Where You Can Find More Information</A></TD>
      <TD STYLE="text-align: center">ii</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD><A HREF="#a_002">Prospectus Summary</A></TD>
      <TD STYLE="text-align: center">1</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_003">Incorporation of Certain Documents By Reference</A></TD>
      <TD STYLE="text-align: center">5</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD><A HREF="#a_011">Note on Forward Looking Statements</A></TD>
      <TD STYLE="text-align: center">6</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_004">The Company</A></TD>
      <TD STYLE="text-align: center">8</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD><A HREF="#a_005">Risk Factors</A></TD>
      <TD STYLE="text-align: center">63</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_006">Selling Stockholders</A></TD>
      <TD STYLE="text-align: center">106</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD><A HREF="#a_007">Use of Proceeds</A></TD>
      <TD STYLE="text-align: center">107</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_008">Plan of Distribution</A></TD>
      <TD STYLE="text-align: center">107</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD><A HREF="#a_009">Legal Matters</A></TD>
      <TD STYLE="text-align: center">108</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD><A HREF="#a_010">Experts</A></TD>
      <TD STYLE="text-align: center">108</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">You should rely only on the
  information contained in or incorporated by reference into this prospectus or any prospectus supplement. We have not authorized any person
  to give any information or to make any representations other than those contained or incorporated by reference in this prospectus, and,
  if given or made, you must not rely upon such information or representations as having been authorized. This prospectus does not constitute
  an offer to sell or the solicitation of an offer to buy any securities other than our shares of Common Stock described in this prospectus
  or an offer to sell or the solicitation to buy such securities in any circumstances in which such offer or solicitation is unlawful. You
  should not assume that the information we have included in this prospectus is accurate as of any date other than the date of this prospectus
  or that any information we have incorporated by reference is accurate as of any date other than the date of the document incorporated
  by reference regardless of the time of delivery of this prospectus or of any securities registered hereunder.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="a_001"></A>WHERE YOU CAN FIND
  MORE INFORMATION</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">The
  Company is subject to the information requirements of the Securities Exchange Act of 1934, as amended (the &ldquo;Exchange Act&rdquo;),
  and, in accordance therewith, files reports, proxy statements and other information with the Commission. We are required to file electronic
  versions of those materials with the Commission through the Commission&rsquo;s EDGAR system. The Commission maintains an Internet site
  at http://www.sec.gov, which contains reports, proxy and information statements and other information regarding registrants that file
  electronically with the Commission. You can read and copy the reports, proxy statements and other information filed by the Company with
  the Commission at such Internet site.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">This
  prospectus constitutes part of a Registration Statement on Form S-8 filed on the date hereof (herein, together with all amendments and
  exhibits, referred to as the &ldquo;Registration Statement&rdquo;) by the Company with the Commission under the Securities Act. This prospectus
  does not contain all of the information set forth in the Registration Statement, certain parts of which we have omitted, in accordance
  with the rules and regulations of the Commission. You should refer to the full Registration Statement for further information with respect
  to the Company and our Common Stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">Statements
  contained herein concerning the provisions of any contract, agreement or other document are not necessarily complete, and in each instance
  reference is made to the copy of such contract, agreement or other document filed as an exhibit to the Registration Statement or otherwise
  filed with the Commission. Each such statement is qualified in its entirety by such reference. Copies of the Registration Statement together
  with exhibits may be inspected at the offices of the Commission as indicated above without charge and copies thereof may be obtained therefrom
  upon payment of a prescribed fee.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">No
  person is authorized to give any information or to make any representations, other than those contained in this prospectus, in connection
  with the offering described herein, and, if given or made, such information or representations must not be relied upon as having been
  authorized by the Company or any Selling Stockholder. This prospectus does not constitute an offer to sell, or a solicitation of an offer
  to buy, nor shall there be any sale of these securities by any person in any jurisdiction in which it is unlawful for such person to make
  such offer, solicitation or sale. Neither the delivery of this prospectus nor any sale made hereunder shall under any circumstances create
  an implication that the information contained herein is correct as of any time subsequent to the date hereto.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center"><B><A NAME="a_002"></A>PROSPECTUS SUMMARY</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: left"><I>The Commission allows us to &lsquo;&lsquo;incorporate
  by reference&rsquo;&rsquo; certain information that we file with the Commission, which means that we can disclose important information
  to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus, and
  information that we file later with the Commission will update automatically, supplement and/or supersede the information disclosed in
  this prospectus. Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall
  be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or
  in any other document that also is or is deemed to be incorporated by reference in this prospectus modifies or supersedes such statement.
  Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
  You should read the following summary together with the more detailed information regarding our company, our Common Stock and our financial
  statements and notes to those statements incorporated herein by reference.</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Our Company</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are a biotechnology company focused on the research
  and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique molecular
  properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines. Our lead influenza
  (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties that enables
  the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and long-term immunity.
  We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines to improve both health
  outcomes and quality of life globally.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our pipeline includes novel vaccine candidates exclusively
  licensed from renowned research institutions. We seek to develop vaccines that provide long-lasting immunity to harmful viral and bacterial
  pathogens that cause infections in patient populations with high unmet needs. Our exclusive license agreements include patented influenza
  epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered by
  Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. Our collaborators are pioneers in vaccine discovery and development.
  We are exploring the development of these influenza ELV&rsquo;s utilizing our Norovirus shell and protrusion (S&amp;P) nanoparticle vaccine
  platform licensed from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC.&nbsp;We are also utilizing our platform to develop
  a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus. Our exclusively licensed <I>S. pneumoniae</I> vaccine
  candidate is from St. Jude Children&rsquo;s Research Hospital. The vaccine is designed to prevent harmful middle-ear infections in children
  and is being developed for intranasal delivery, well suited for pediatric patients. We leverage the expertise of our collaborators to
  pursue the discovery and development of vaccines for these diseases, which are high unmet needs globally.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we have expertise in identifying business
  development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion and the
  ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There is
  potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccination has been used as an effective method
  of protecting individuals against harmful diseases by utilizing the body&rsquo;s natural defense system to develop resistance or immunity
  to infections (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>). The body&rsquo;s
  immune system naturally creates antibodies and cell -mediated immunity to defend against foreign pathogens. Vaccines introduce or present
  these foreign pathogens, prompting the body&rsquo;s immune system produce a response protective against the pathogen without exposing
  the body to the relevant lethal or harmful infection (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>).
  While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to shortcomings
  of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to the current standards
  of care by harnessing durable and long-lived immune response to specific or multiple antigens.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <DIV STYLE="padding: 5.4pt; border: Black 1.5pt solid">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global vaccine market has recently experienced
  significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
  by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
  immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As such, market research professionals project the
  global vaccine market size to reach $73.78&nbsp;billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
  prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This market acceleration has been coupled with various
  strategic transactions in the sector, including consolidations and mergers and acquisitions in recent&nbsp;years. Major market participants
  have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings. For instance,
  in February&nbsp;2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines across the
  globe. Additionally, in October&nbsp;2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired PaxVax
  for $270&nbsp;million, and in July&nbsp;2017 Sanofi acquired Protein Sciences for $650&nbsp;million. The appetite of these companies to
  buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
  and worldwide.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;Centers for Disease Control, or CDC,
  its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations for
  both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
  vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
  obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
  adoption.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Pipeline</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine candidates are being developed in a
  manner that is scalable, designed to be cost-effective and provide long-term benefit to patients from infectious agents.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_001.jpg" ALT=""></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Vaccine Platform</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Approach to Stimulating the Immune System for Infectious Disease
  Protection</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our S&amp;P platform was co-invented by two researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children&rsquo;s Hospital Medical
  Center. The pre-clinical research conducted at CHMC provided encouraging data that we believe supports investigation and development of
  the platform for our vaccine candidates. The S&amp;P platform combines two or more immunogenic components, a norovirus antigen plus at
  least one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <DIV STYLE="padding: 5.4pt; border: Black 1.5pt solid">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Key Elements of our Platform</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are leveraging our disruptive norovirus nanoparticle
  platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Flexible and Scalable discovery platform engine.&nbsp;&nbsp;&nbsp;&nbsp;</I>We
  believe we are able to design and create novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform&rsquo;s
  adaptability, we may opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as
  well as therapeutics.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Cost-effective and Rapid Production of Novel Vaccines.&nbsp;&nbsp;&nbsp;&nbsp;</I>We
  are potentially able to reduce the cost and time to manufacture a vaccine candidate by utilizing an <I>E.coli</I> expression platform,
  compared to traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells.
  We have bioengineered these nanoparticles to be stable and effective, determined through animal immunogenicity studies, using <I>E.coli
  </I>expression, which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system (Pharmaceutics
  2019, 11, 472; doi:10.3390/pharmaceutics11090472).</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Multi-antigen and Pathogen Capabilities.&nbsp;&nbsp;&nbsp;&nbsp;</I>The
  power of our platform is its ability to carry multiple antigens at a time, thereby creating a multi-targeted vaccine. It also provides
  the opportunity to develop vaccines for protection against not only viral pathogens, but also bacterial, parasitic and fungal pathogens.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><I>Therapeutic potential.&nbsp;&nbsp;&nbsp;&nbsp;</I>We believe
  our platform may offer opportunities to develop non-infectious disease therapeutic products, for example, being used as a carrier or
  vehicle to transport drugs to specific target locations.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Vaccine Candidates</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101 and BWV-102: Influenza vaccine program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our lead vaccine program is focused on developing
  a transformational novel universal influenza vaccine, BWV-101. This program is licensed from the University of Oxford, where all relevant
  studies were performed to support our hypothesis. We are developing a broad-spectrum vaccine using patented epitopes of limited variability,
  or ELV, that provide cross reactive immune response to multiple historical flu strains. Additionally, based upon the successful pre-clinical
  proof-of-concept (POC) of our H1 epitopes, we are developing a stand-alone H1 influenza vaccine, BWV-102, to provide a long-lasting induced
  immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1, H3 and influenza
  B.&nbsp;Data in mice models have demonstrated proof of concept of neutralization against historical and current H1 strains, which includes
  annual and pandemic strains. This would negate annual flu shots, reformulation and potentially provide protection against future influenza
  pandemics. (Thompson et al. Nature Communications. 2018. 9:385).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-201: Streptococcus pneumoniae (S. pneumoniae) vaccine program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing BWV-201, licensed from St. Jude
  Children&rsquo;s Research Hospital, to prevent Acute Otitis Media, or AOM, in children and adults, a leading cause of hospital visits,
  prescription antibiotics and potentially permanent hearing loss. AOM due to <I>S. pneumoniae</I> infections range from 30 to 50% of all
  AOM infections each year (Monsata 2012 2012; 7(4): e36226). BWV-201 is a live attenuated serotype-independent intranasal vaccine candidate
  for <I>S.&nbsp;pneumoniae</I> induced AOM.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-301: Norovirus-rotavirus vaccine program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing a norovirus-rotavirus vaccine,
  BWV-301, to prevent gastroenteritis utilizing our S&amp;P platform. Preclinical data from gnotobiotic pig studies have shown our vaccine
  can prevent severe gastroenteritis and reduces viral shedding. While rotavirus vaccines exist in the market, no norovirus vaccine is available
  to date. Our vaccine would protect people from two of the most globally prevalent viruses causing vomiting and diarrhea.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-302: Norovirus-malaria vaccine program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, we are currently investigating a malaria vaccine, BWV-302,
  utilizing our norovirus S&amp;P platform. The vaccine is designed to offer protection from both norovirus and malaria, infectious diseases
  that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of the plasmodium parasite
  being presented on the surface of the norovirus nanoparticle.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt">&nbsp;</P>
  
  <DIV STYLE="margin-right: 9.7pt; margin-left: 9.7pt; padding: 0in; border: white 1pt solid">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Corporate Information</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  were incorporated in Delaware on October&nbsp;26, 2018. Our principal executive offices are located at 201&nbsp;E.&nbsp;Fifth Street,
  Suite 1900, Cincinnati, Ohio 45202, and our telephone number is (513)&nbsp;620-4101. Our corporate website </FONT>address <FONT STYLE="font-family: Times New Roman, Times, Serif">is
  <I>www.bluewatervaccines.com</I>. The information contained on or accessible through our website is not a part of this prospectus, and
  the inclusion of our website address in this prospectus is an inactive textual reference only.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt; text-align: center"><B>The Offering</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 8.7pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 29%; text-align: justify"><B>Outstanding Common Stock:</B></TD>
      <TD STYLE="width: 1%; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 70%; text-align: justify">12,229,399 shares of our Common Stock are outstanding as of June 24,
  2022.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify"><B>Common Stock Offered:</B></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: left">Up to 1,600,000 shares of Common Stock for sale by the Selling Stockholders (which include our employees, consultants, executive officers and directors) for their own account pursuant to the 2019 Plan and the 2022 Plan.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify"><B>Selling Stockholders:</B></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: left">The Selling Stockholders are set forth in the section entitled &ldquo;Selling Stockholders&rdquo; of this reoffer prospectus on page 106. The amount of securities to be offered or resold by means of the reoffer prospectus by the designated Selling Stockholders may not exceed, during any three month period, the amount specified in Rule 144(e).</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify"><B>Use of proceeds:</B></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: left">We will not receive any proceeds from the sale of our Common Stock by the Selling Stockholders. We would, however, receive proceeds upon the exercise of the stock options by those who receive options under the Plan and exercise such options for cash. Any cash proceeds will be used by us for general corporate purposes.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify"><B>Risk Factors:</B></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: left">The securities offered hereby involve a high degree of risk. See &ldquo;Risk Factors.&rdquo;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify"><B>Nasdaq Capital Market trading symbol:</B></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">BWV</TD></TR>
    </TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  </DIV>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_003"></A>INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in; background-color: white">We
  are &ldquo;incorporating by reference&rdquo; in this prospectus certain documents we file with the Commission, which means that we can
  disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
  is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
  by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
  in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
  differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
  are incorporated herein by reference as of their respective dates of filing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 1.05pt; text-align: justify">(i)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Annual Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">(ii)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Quarterly Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001782107/000121390022026516/f10q0322_bluewatervac.htm">Form 10-Q</A> for the quarter ended March 31, 2022 as filed with the SEC on May 13, 2022;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">(iii)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Current Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022010779/ea156505-8ka1_bluewater.htm">Form 8-K/A</A> dated March 4, 2022, our Current Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022014172/ea157195-8k_bluewater.htm">Form 8-K</A> dated March 22, 2022; our Current Report on <A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022020636/ea158617-8k_bluewater.htm">Form 8-K</A> dated April 19, 2022; our Current Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001782107/000121390022020726/ea158657-8k_bluewater.htm">Form 8-K</A> dated April 20, 2022; our Current Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001782107/000121390022020785/ea158659-8k_bluewater.htm">Form 8-K</A> dated April 20, 2022; our Current Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001782107/000121390022020876/ea158704-8k_bluewater.htm">Form 8-K</A> dated April 21, 2022; our Current Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/0001782107/000121390022029402/ea160571-8k_bluewater.htm">Form 8-K</A> dated May 25, 2022;  our Current Report on <A HREF="https://www.sec.gov/ix?doc=/Archives/edgar/data/1782107/000121390022030666/ea160890-8k_bluewater.htm">Form 8-K</A> dated June 1, 2022; and our Current Report on <A HREF="https://www.sec.gov/Archives/edgar/data/1782107/000121390022034900/ea161977-8k_bluewater.htm">Form 8-K</A> dated June 24, 2022.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: justify">(iv)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">the description of our securities registered under Section 12 of the Exchange Act as filed as&nbsp;<A HREF="https://www.sec.gov/Archives/edgar/data/0001782107/000121390022016672/f10k2021ex4-2_bluewater.htm">Exhibit 4.2</A>&nbsp;on Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.</TD></TR>
    </TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">All documents that we file
  with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
  indicates that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold,
  will be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Any statement contained in
  a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
  for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
  also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
  superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
  of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
  furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
  by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
  to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
  incorporated by reference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">You may request, orally or in writing, a copy of these documents, which
  will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated by reference), by contacting
  Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our telephone number is (513)
  620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However, the information on our website
  is not a part of this prospectus and is not incorporated by reference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_011"></A>CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
  AND INDUSTRY AND MARKET DATA</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Special Note&nbsp;Regarding Forward-Looking Statements</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in">This prospectus contains forward-looking statements
  that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled &ldquo;Prospectus
  Summary,&rdquo; &ldquo;Risk Factors&rdquo; and &ldquo;The Company,&rdquo; but are also contained elsewhere in this prospectus. In some
  cases, you can identify forward-looking statements by the words &ldquo;may,&rdquo; &ldquo;might,&rdquo; &ldquo;will,&rdquo; &ldquo;could,&rdquo;
  &ldquo;would,&rdquo; &ldquo;should,&rdquo; &ldquo;expect,&rdquo; &ldquo;intend,&rdquo; &ldquo;plan,&rdquo; &ldquo;objective,&rdquo; &ldquo;anticipate,&rdquo;
  &ldquo;believe,&rdquo; &ldquo;estimate,&rdquo; &ldquo;predict,&rdquo; &ldquo;project,&rdquo; &ldquo;potential,&rdquo; &ldquo;continue&rdquo;
  and &ldquo;ongoing,&rdquo; or the negative of these terms, or other comparable terminology intended to identify statements about the future,
  although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance
  or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity,
  performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking
  statements include, but are not limited to, statements about:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our projected financial position and estimated cash burn
  rate;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our estimates regarding expenses, future revenues and capital
  requirements;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our ability to continue as a going concern;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our need to raise substantial additional capital to fund
  our operation;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the success, cost and timing of our clinical trials;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our dependence on third parties in the conduct of our clinical
  trials;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our ability to obtain the necessary regulatory approvals
  to market and commercialize our product candidates;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the ultimate impact of the ongoing COVID-19 pandemic, or
  any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a
  whole;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the potential that results of pre-clinical and clinical trials
  indicate our current product candidates or any future product candidates we may seek to develop are unsafe or ineffective;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the results of market research conducted by us or others;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to obtain and maintain intellectual property
  protection for our current product candidates;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to protect our intellectual property rights and
  the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the possibility that a third party may claim we or our third-party
  licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial
  costs and be required to devote substantial time defending against claims against us;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">our reliance on third parties;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the success of competing therapies and products that are
  or become available;</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">our ability to expand our organization to accommodate potential
  growth and our ability to retain and attract key personnel;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">the potential for us to incur substantial costs resulting
  from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization
  of our product candidates;</TD>
  </TR></TABLE>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">market acceptance of our product candidates, the size and
  growth of the potential markets for our current product candidates and any future product candidates we may seek to develop, and our
  ability to serve those markets; and</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">the successful development of our commercialization capabilities,
  including sales and marketing capabilities.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These forward-looking statements are subject to
  a number of risks, uncertainties and assumptions, including those described in &ldquo;Risk Factors.&rdquo; Moreover, we operate in a very
  competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all
  risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause
  actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties
  and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ
  materially and adversely from those anticipated or implied in the forward-looking statements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You should not rely upon forward-looking statements
  as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
  we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking
  statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for
  the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements
  for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You should read this prospectus and the documents
  that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus forms
  a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially
  different from what we expect.&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_004"></A>THE COMPANY</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Overview</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are a biotechnology company focused on the
  research and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique
  molecular properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines.
  Our lead influenza (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties
  that enables the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and
  long-term immunity. We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines
  to improve both health outcomes and quality of life globally.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our pipeline includes novel vaccine candidates
  exclusively licensed from renowned research institutions. We seek to develop vaccines that provide long-lasting immunity to harmful viral
  and bacterial pathogens that cause infections in patient populations with high unmet needs. Our exclusive license agreements include patented
  influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered
  by Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. Our collaborators are pioneers in vaccine discovery and development.
  We are exploring the development of these influenza ELV&rsquo;s utilizing our Norovirus shell and protrusion (S&amp;P) nanoparticle vaccine
  platform licensed from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC.&nbsp;We are also utilizing our platform to develop
  a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus. Our exclusively licensed S. pneumoniae vaccine
  candidate is from St. Jude Children&rsquo;s Research Hospital. The vaccine is designed to prevent harmful middle-ear infections in children
  and is being developed for intranasal delivery well suited for pediatric patients. We leverage the expertise of our collaborators to pursue
  the discovery and development of vaccines for these diseases, which are high unmet needs globally.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we have expertise in identifying
  business development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion
  and the ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There
  is potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccination has been used as an effective method
  of protecting individuals against harmful diseases by utilizing the body&rsquo;s natural defense system to develop resistance or immunity
  to infections (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>). The body&rsquo;s
  immune system naturally creates antibodies and cell&nbsp;mediated immunity to defend against foreign pathogens. Vaccines
  introduce or present these foreign pathogens, prompting the body&rsquo;s immune system produce a response protective against the pathogen
  without exposing the body to the relevant lethal or harmful infection (World Health Organization, <I>https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19</I>).
  While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to shortcomings
  of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to the current standards
  of care by harnessing durable and long-lived immune response to specific or multiple antigens.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global vaccine market has recently experienced
  significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
  by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
  immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As such, market research professionals project
  the global vaccine market size to reach $73.78&nbsp;billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
  prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This market acceleration has been coupled with
  various strategic transactions in the sector, including consolidations and mergers and acquisitions in recent&nbsp;years. Major market
  participants have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings.
  For instance, in February&nbsp;2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines
  across the globe. Additionally, in October&nbsp;2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired
  PaxVax for $270&nbsp;million, and in July&nbsp;2017 Sanofi acquired Protein Sciences for $650&nbsp;million. The appetite of these companies
  to buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
  and worldwide.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;Centers for Disease Control, or
  CDC, its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations
  for both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
  vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
  obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
  adoption.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>PIPELINE</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine candidates are being developed in
  a manner that is scalable, designed to be cost-effective and provide long term benefit to patients from infectious agents.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><IMG SRC="image_002.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Strategy</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We aim to identify, discover and develop novel
  preventive vaccines for infectious diseases. Key elements of our strategy include:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Investment in advancing the development of our novel vaccine
  pipeline programs through IND-enabling activities and Phase&nbsp;I clinical studies.</B></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We plan to advance our main vaccine programs: influenza, <I>S.
  pneumoniae</I> induced AOM norovirus-rotavirus, and norovirus-malaria.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our in-licensed vaccine candidates are carefully selected
  based on the following criteria: area of significant unmet medical need for preventive long-term vaccine; strong scientific rationale
  and established clinical and regulatory pathways; defined competitive landscape and potential future commercial opportunity; and license
  exclusivity.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Prioritizing the research and development for our lead
  influenza vaccine candidates, BWV-101 and BWV-102 through Phase&nbsp;I.</B></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our goal is to develop a universal influenza vaccine that
  protects against all strains of influenza, including pandemic strains. In collaboration with The University of Oxford and CHMC, we are
  evaluating vaccine candidates to pursue the best development path forward to stimulate durable and broad-spectrum immunogenicity.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We will leverage the pre-clinical and clinical experience
  we gain from the development of BWV-102 to accelerate the development of the BWV-101 program. We expect that the manufacturing and clinical
  data collected will provide invaluable insight for development of the universal vaccine candidate.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Maximize and utilize the value of our collaborators and
  third-party vendors.</B></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We will combine disciplined business strategies to further
  expand the potential synergies with current collaborators.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify"><B>Deploy and expand our proprietary norovirus S&amp;P nanoparticle
  platform.</B></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Our immunogenic multi-purpose vaccine platform technologies
  can be utilized with an array of infectious disease agents to access multiple development pathways and allow for potential next-generation
  life cycle management to expand our pipeline and pursue business development opportunities. There is potential for the platform to pursue
  adjunctive therapies to currently available drugs, and for current therapies to be re-optimized and formulated to protect against multiple
  antigens.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Management and History</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Blue Water Vaccines Inc. was founded in October&nbsp;2018
  by our Chief Executive Officer, or CEO, Joseph Hernandez, with the initial goal of developing a transformational universal flu vaccine
  to treat and prevent infections in patients globally. Our initial technology, licensed from the University of Oxford, provides a novel
  approach to developing a universal influenza vaccine. Subsequently, our team has identified other program candidates and technologies
  to broaden and diversify our vaccine pipeline.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Mr.&nbsp;Hernandez, our Chairman and CEO, is a
  veteran entrepreneur, philanthropist, and operator with a broad skillset of founding, building, and selling companies, as well as executing
  business development transactions and securing private and public capital, including Digene, Noachis Terra and Blue Water Acquisition
  Corp. Mr.&nbsp;Hernandez was responsible for our initial $7&nbsp;million seed funding round from investors including CincyTech. In addition
  to his position as our Chairman and CEO, Mr.&nbsp;Hernandez also serves on the board of directors for Clarus Therapeutics, Inc. (Nasdaq:
  CRXT) in addition to certain other private companies. Subsequently, a team of veteran industry executives and advisors were assembled,
  bringing valuable expertise to our growing infectious disease company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Jon Garfield, our Chief Financial Officer, has
  over 20&nbsp;years of financial leadership experience, including with healthcare companies. Mr.&nbsp;Garfield regularly provides consulting
  services to private equity funds and privately held companies and has served as the CEO of Unity MSK since February&nbsp;2021, and served
  as interim Chief Financial Officer of Blue Water Vaccines Inc. from September&nbsp;2021 until the consummation of our initial public offering
  in February&nbsp;2022, upon which he became our full-time Chief Financial Officer. Erin Henderson, who serves as our Chief Business Officer
  and Corporate Secretary, has over 20&nbsp;years of leading strategic transactions, governmental and stakeholder relations and corporate
  expansion. Previously, since 2010, she was the Managing Principal at The Aetos Group, a management consulting firm serving both the public
  and private sectors. Andrew Skibo is our Head of Biologic Operations and was recently Head of Global Biologics Operations at MedImmune/AstraZeneca
  and previously worked for Amgen and Genentech (now Roche), where he was responsible for operations, engineering, construction, and validation
  for large-scale capital projects related to bio-pharmaceutical manufacturing. Ronald Cobb, Ph.D., our Head of Science and Discovery, was
  recently Chief Scientific Officer at Ology Bioservices (formerly Nanotherapeutics) and previously worked for RTI Biologics and Berlex
  Biosciences. Brian Price, Ph.D., our Head of Technology Strategy, brings over 20&nbsp;years of successful product development experience
  and business development growth based on programs in toxicology, analytics, and therapeutic and vaccine development.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, members of our Board of Directors
  have extensive expertise in the fields of life sciences, business, and finance. In addition to Mr.&nbsp;Hernandez, our directors include
  Michael Venerable, CEO of CincyTech, Kimberly Murphy, former VP, Commercialization Leader, influenza at GlaxoSmithKlein, President, CEO
  and Director of Oragenics, Inc. (Nasdaq: OGEN) and Chair of Clarus Therapeutics (Nasdaq: CRXT), Allan Shaw, an experienced biotechnology
  CFO, and James Sapirstein, R.Ph., M.B.A, President, CEO and Chairman of First Wave BioPharma, Inc. (Nasdaq:FWBI). Our Scientific Advisory
  Board includes Sunetra Gupta, Ph.D.&nbsp;Professor of Theoretical Epidemiology at The University of Oxford, a leading voice in infectious
  disease globally; David Zarley, Ph.D., with more than 30&nbsp;years of experience in vaccine research and development, including former
  leadership roles at Pfizer and Wyeth; and John Rice, Ph.D., Managing Director at CincyTech, with more than 30&nbsp;years of biotechnology
  advising experience.</P>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Subject to certain non-compete restrictions, our
  chief executive officer, Joseph Hernandez, and other key personnel may pursue other business or investment ventures while employed with
  us. Accordingly, they may have conflicts of interest in allocating time among various business activities and potentially competitive
  fiduciary and pecuniary interests that conflict with our interests. See &ldquo;Risk Factors&nbsp;&mdash;&nbsp;Our Chief Executive Officer,
  Joseph Hernandez and our Chief Financial Officer, Jon Garfield, hold certain management positions and directorships of other companies
  and may allocate their time to such other businesses, which may cause conflicts of interest in their determination as to how much time
  to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.&rdquo; Any such
  additional business activities or ventures may present conflicts to our interests. We do not believe that any such potential conflicts
  would materially affect our ability to conduct our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Vaccine Platform</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>Bioengineering the shell (S)&nbsp;and protruding
  (P)&nbsp;domains of the norovirus capsid protein, polyvalent nanoparticles and polymers/oligomers provide a versatile vaccine platform
  with wide applications</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>Our Approach to Stimulating the Immune System
  for Infectious Disease Protection</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our S&amp;P platform was co-invented by two researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children&rsquo;s Hospital Medical
  Center. The pre-clinical research conducted at CHMC provided encouraging data that supports further investigation and development of the
  platform for our vaccine candidates. The S&amp;P platform combines two or more immunogenic components, a norovirus antigen plus at least
  one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity of the inserted antigen.
  The S&nbsp;&amp; P particles themselves also act as antigens, and are large enough to trigger an immune response to a foreign substance.
  By combining the norovirus nanoparticle with one or more antigens from other infectious disease(s), the immune system is stimulated to
  create antibodies to both the norovirus and the additional antigen(s).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Key Elements of our Platform</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are leveraging our disruptive norovirus nanoparticle
  platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left"><I>Flexible and Scalable discovery platform engine. </I>We
  believe we are able to design and create novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform&rsquo;s
  adaptability, we may opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as
  well as therapeutics.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left"><I>Cost-effective and Rapid Production of Novel Vaccines.
  </I>We are potentially able to reduce the cost and time to manufacture a vaccine candidate by utilizing an E.coli expression platform,
  compared to traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells.
  We have bioengineered these nanoparticles to be stable and effective, as determined through animal immunogenicity studies, using <I>E.coli
  </I>expression which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system. (Pharmaceutics
  2019, 11, 472; doi:10.3390/pharmaceutics11090472).</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>&#9679;</I></TD><TD STYLE="text-align: left"><I>Multi-antigen and Pathogen Capabilities. </I>One of the
  key features of our platform is its ability to carry multiple antigens at a time, thereby creating a multi-targeted vaccine. It also
  provides the opportunity to develop vaccines for protection against not only viral pathogens, but also bacterial and potentially parasitic
  and fungal pathogens.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>&#9679;</I></TD><TD STYLE="text-align: left"><I>Therapeutic potential. </I>We believe our platform may
  offer opportunities to develop non-infectious disease therapeutic products, for example being used as a carrier or vehicle to transport
  drugs to specific target locations.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Viral capsid proteins are responsible for many
  basic functions necessary for viral life cycles, such as viral attachment and entry, and thus can elicit neutralizing antibodies against
  viral infection after immunization to humans and animals. Consequently, viral capsid proteins are promising vaccine targets against viral
  infection. Indeed, various capsid protein nanoparticles and complexes have been developed and used as nonreplicating subunit vaccines
  to combat various infectious diseases.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Unlike traditional live-attenuated and inactivated
  virus vaccines that need cultivation of infectious virions and are associated with certain safety concerns, the nonreplicating VLP vaccines
  derived from bioengineered viral capsid proteins do not involve an infectious agent and, therefore, may be safer and have lower manufacturing
  costs than traditional vaccines. Thus, VLP vaccines represent a next generation of innovative vaccine strategy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Structure</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The NoV (VP1) capsid structure consists of two major domains:
  (i) a N-terminal shell (S)&nbsp;domain and (ii) a C-terminal protruding (P)&nbsp;domain. The S domain builds the interior shell of the
  capsid and the P domain forms the dimeric protrusions of the capsid.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The protrusions (P)&nbsp;of norovirus capsid interact with
  viral glycan receptors for attachment to host cells to initiate an infection.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The S domain interacts homotypically and drives self-formation
  of an approximately 60 nm VLP.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The P domain exhibits homotypic interactions, forming a 24
  nm VLP with dimeric protrusions for stabilization of the viral capsid. Additionally, it can also form oligomers or polymers.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_003.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 1. </B>Lineage structures of norovirus
  capsid protein or viral protein 1 (VP1) and various nanoparticles derived from full-length or truncated VP1. The N-terminal shell (S)&nbsp;(green)
  and the C-terminal protruding (P)&nbsp;(dark blue) domains with a short flexible hinge (light blue) in between (with amino acid numbers
  based on GI.1 Norwalk virus VP1) are shown. (A)&nbsp;Production of full-length norovirus VP1s via a eukaryotic expression system self-assembles
  into virus-like particles (VLPs). (B)&nbsp;Production of the S or P domain via the <I>Escherichia coli</I> expression system self-assembles
  into S or P nanoparticles.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
  <!-- Field: Page; Sequence: 18; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Due to the homotypic interaction attributed to
  the norovirus capsid domains, researchers at CHMC, through bioengineering, designed and generated two subviral nanoparticles, the 24-valent
  P<SUB>24 </SUB>and the 60-valent S<SUB>60</SUB> nanoparticles, and P-derived polymers to serve as a multifunctional vaccine platform against
  different pathogens and illnesses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">These nanoparticles and polymers are easily produced, highly
  stable, and extremely immunogenic which we believe makes them compelling platforms to serve to display foreign antigens, self-assembling
  into chimeric nanoparticles or polymers as vaccine candidates.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">There are several preclinical studies that showed P<SUB>24</SUB>/S<SUB>60
  </SUB>chimeric vaccine candidates that can display different foreign antigens and epitopes, as set forth below in Tables 1 and 2. Therefore,
  there may be additional candidates to further explore as human vaccines. <I>(Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I>.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Such VLPs and capsid-like nanoparticles may be excellent
  vaccine candidates against corresponding viral pathogens because they can retain arrays of antigenic epitopes that faithfully mimic those
  of the native virions, and these repeated viral antigens and epitopes stimulate strong immune responses in their animal and human hosts.
  In addition, such highly immunogenic subviral nanoparticles may also serve as versatile platforms that are able to display foreign antigens
  for improved immune responses to facilitate development of novel vaccines against various pathogens and diseases.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The fact that the P<SUB>24</SUB> VLP nanoparticles and polymers
  are composed of authentic norovirus antigens and retain norovirus-specific molecular patterns make it an excellent vaccine candidate
  against the norovirus.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">In addition, the natures of self-formation, high stability,
  polyvalence, and high immunogenicity, as evidenced by animal studies conducted in gnotobiotic pig models and mouse models, results included
  herein, of the nanoparticles and polymers make them strong vaccine candidate platforms to display foreign antigens, resulting in chimeric
  nanoparticles as vaccine candidates against further pathogens and diseases.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our multifunctional vaccine platform is a robust
  discovery engine and has broad application using both S<SUB>60</SUB> and P<SUB>24</SUB> nanoparticles to target multiple pathogens and
  illnesses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The P<SUB>24</SUB> nanoparticle has also been
  used to display multiple viral epitopes for enhanced immunogenicity for novel subunit vaccine development, see Table 1 below. These include
  the M2e epitope of the matrix 2 (M2) protein and the HA2 protein B cell epitope of influenza viruses, the B cell epitope of VP3 of enterovirus
  71 (EV71), the 4E10 and 10E8 epitopes of human immunodeficiency virus type 1 (HIV-1), among others.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 1. Summary of norovirus nanoparticles and polymers as vaccine
  candidates and platforms to display foreign antigens and epitopes.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 16%; border-bottom: black 1.5pt solid; text-align: center"><B>Nanoparticle/ Polymer</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 26%; border-bottom: black 1.5pt solid; text-align: center"><B>Antigen/Epitope to be Displayed (Pathogen)</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 26%; border-bottom: black 1.5pt solid; text-align: center"><B>Chimeric Products as <BR>
  Vaccine Candidate</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 29%; border-bottom: black 1.5pt solid; text-align: center"><B>Immunity against <BR>
  Pathogens or Diseases</B></TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">S<SUB>60</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">VP8* (rotavirus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">S<SUB>60</SUB>&nbsp;&ndash;&nbsp;VP8*</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Rotavirus</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P domain (norovirus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Norovirus</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">VP8* (rotavirus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P<SUB>24</SUB>&nbsp;&ndash;&nbsp;VP8*</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Rotavirus and norovirus</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">M2e (influenza virus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P<SUB>24</SUB>&nbsp;&ndash;&nbsp;M2e</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Influenza virus</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">HA2 B cell epitope <BR>
  (influenza virus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Trivalent HA2-PP (P<SUB>24</SUB>-HA2:90-105)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Influenza A virus and influenza B virus</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">VP3 B cell epitope (EV71)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">PP-71-6 (P<SUB>24</SUB>-71-6)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">EV71</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">4E10/10E8 epitopes (HIV-1)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">4E10-PP/10E8-PP</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">HIV-1</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P<SUB>24</SUB></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Amyloid-beta, A&beta;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">PP-3copy-A&beta;1-6</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Alzheimer&rsquo;s disease</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">P polymer</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P domains (noroviruses)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">NoV P<SUB>GI</SUB>-NoV P<SUB>GII</SUB> <BR>
  GST NoV P<SUP>+</SUP></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Different noroviruses</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P polymer</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P domain (HEV)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">NoV P-HEV P</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Norovirus and HEV</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">P polymer</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P domain (astrovirus) P domain (HEV)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Ast P-HEV P-NoV P</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Norovirus, astrovirus, <BR>
  and HEV</TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">P polymer</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">P domain (astrovirus) P domain (HEV) <BR>
  VP8* (rotavirus)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Ast P-HEV P-VP8*</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">Rotavirus, astrovirus, <BR>
  and HEV</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Note: EV71, enterovirus 71; HIV-1, human immunodeficiency virus type
  1; HEV, hepatitis E virus; Ast, astrovirus, NoV, norovirus, P, protruding domain; P+, the P domain with an end-linked cysteine-containing
  peptide that can self-assemble into oligomers; PP, P particle; GI, norovirus genogroup&nbsp;I; GII, norovirus genogroup&nbsp;II.&nbsp;Please
  see the main text for details.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>The S<SUB>60</SUB> Nanoparticle as a Multifunctional vaccine platform</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Recent technology has generated S nanoparticles
  using an <I>E. coli</I> system with stabilized expression and self-assembly. The S nanoparticles feature exposed C-terminal flexible hinge
  sites that offer ideal fusion sites for displaying foreign antigens.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Researchers at CHMC have developed a technology
  to produce uniform 60-valent NoV S<SUB>60 </SUB>nanoparticles with high efficiency using a simple bacterial expression system. This was
  achieved by taking advantage of the homotypic interactions of the NoVVP1 S domain that naturally builds the interior shells of NoV capsids,
  as well as several modifications to stabilize the S domain proteins and enhance the inter-S domain interactions, respectively. Specifically,
  we introduced an R69A mutation to destruct the exposed protease cleavage sites on the surface of the native shell that otherwise leads
  to easy degradation of the S proteins. In addition, we introduced triple (V57C/Q58C/S136&rsquo;C) cysteine mutations to establish inter-S
  domain disulfide bonds between two pairs of sterically close residues that belong to two neighboring S domains. This led to significantly
  enhanced stability and yields of the self-assembled S<SUB>60</SUB> nanoparticles produced by the simple <I>E. coli</I> system. The below
  bullets are supported by published data by Ming Tan, the co-inventor of the S&amp;P platform, and his research team at CHMC.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">An important feature of our technology was to rationally
  introduce intermolecular disulfide bonds to stabilize the S<SUB>60</SUB> nanoparticles. This approach could also be used to stabilize
  other viral protein particles or complexes.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The 60 freely exposed C-termini are a key feature facilitating
  the S<SUB>60</SUB> nanoparticle to be a useful vaccine platform. Foreign antigens or epitopes can simply be fused to the end of the S
  domain via flexible linker through recombinant DNA technology.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Uniform 60-valent NoV VLPs or S particles produced in a bacterial
  expression system have not been produced before.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Importantly, our S<SUB>60</SUB> nanoparticles maintained
  the native conformation with authentic antigenicity; thus, our NoV S<SUB>60</SUB> nanoparticle technology represents a significant bioengineering
  advancement as uniform 60-valent NoV VLP or S particle <I>via</I> an expression system have never been produced before (Xia et al. ACS
  Nano 2018, 12, 10665&minus;10682).</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Uniform complexity and size of vaccine particles are important
  factors in quality control of vaccine products, as variations in complexity and size will result in variations in immunization outcomes
  of the vaccines.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Broad application to fuse several antigens to the S<SUB>60</SUB>
  nanoparticle based on multiple studies shown below conducted by CHMC (Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC has been able to fuse several antigens to
  the S<SUB>60</SUB> nanoparticle to the same exposed S domain C-terminus via the same linker. These included (1)&nbsp;the rotavirus (RV)
  surface spike protein VP8*; (2)&nbsp;the HA1 antigen or receptor-binding domain (RBD) (223&nbsp;amino acids) of the hemagglutinin (HA)
  of anH7N9 influenza A virus; (2)&nbsp;the TSR antigen (67&nbsp;amino acids) of the circumsporozoite surface protein (CSP) of the malaria
  parasite Plasmodium falciparum; (3)&nbsp;the protruding domain antigen (187&nbsp;amino acids) of a hepatitis E virus; (4)&nbsp;a longer
  version of the RV VP8*antigen (231&nbsp;amino acids); and (5)&nbsp;the VP8*antigen (159&nbsp;amino acids) of the murine RV (mRV) EDIM
  strain (Table 1). Particle formations of these fusion proteins have been shown by gel-filtration and/or EM (Table1). In addition, they
  have shown that the S<SUB>60</SUB>nanoparticle-displayed HA1 and mRV VP8*antigens elicited significantly higher HA1- and mRV VP8*-specific
  antibody titers, respectively, than those elicited by the free HA1 or mRV VP8*antigens (Table 2).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 2. List of Antigens That Have Been Displayed by the S<SUB>60</SUB>
  Nanoparticles</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid"><B>epitope/antigen</B></TD>
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>size <BR>
  (residue)</B></TD>
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>yield (mg/L <BR>
  bacteria culture)</B></TD>
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>S<SUB>60</SUB>&nbsp;&ndash;&nbsp;antigen <BR>
  particle<BR>
   formation</B></TD>
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><B>significant<BR>
   immune<BR>
   enhancement<BR>
   in mice<I><SUP>f</SUP></I></B></TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="width: 62%">RV VP8* antigen</TD>
      <TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 8%; text-align: center">159</TD>
      <TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 8%; text-align: center">~40</TD>
      <TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 8%; text-align: center">yes</TD>
      <TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 8%; text-align: center">yes</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD>HA1 antigen<I><SUP>a</SUP></I></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">223</TD>
      <TD>&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">~10</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD>TSR/CSP antigen<I><SUP>b</SUP></I></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">67</TD>
      <TD>&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">~10</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">ND</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD>full RV VP8* antigen<I><SUP>c</SUP></I></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">231</TD>
      <TD>&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">~20</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">ND</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD>murine RV VP8* antigen<I><SUP>d</SUP></I></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">159</TD>
      <TD>&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">~5</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD>HEV protruding domain antigen<I><SUP>e</SUP></I></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: center">187</TD>
      <TD>&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">~10</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">yes</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">ND</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>a</I></TD>
      <TD>HA1 antigen containing the receptor binding site is the head portion of the hemagglutinin (HA) of H7N9 influenza A virus.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>b</I></TD>
      <TD>TSR/CSP antigen is the C-terminal portion of the major surface protein of acircumsporozoite (CSP) that plays a key role in host cell invasion of the malaria parasite Plasmodium falciparum.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>c</I></TD>
      <TD STYLE="text-align: justify">Full RV VP8*antigen is the full-length VP8*domain of the spike protein of a human P[8] rotavirus.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>d</I></TD>
      <TD>Murine RV VP8*antigen is the core portion of the VP8*protein constituting the head of the spike protein of a murine rotavirus EDIM strain.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>e</I></TD>
      <TD STYLE="text-align: justify">HEV protruding domain antigen is part of the protruding domain of a hepatitis E virus capsid.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px"><I>f</I></TD>
      <TD>Immune enhancements of the S<SUB>60</SUB> nanoparticle-displayed antigens were measured in mice using free monomeric antigens as control for comparisons. &ldquo;ND&rdquo; = not determined.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>S<SUB>60</SUB> nanoparticles may serve as a polyvalent vaccine platform
  (Xia et al. ACS Nano 2018, 12, 10665&minus;10682)</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">We believe the self-assembled, polyvalent S<SUB>60</SUB>
  nanoparticle with 60 flexibly exposed S domain C-termini is an ideal vaccine platform for antigen presentation and immunogenicity enhancement.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">This has been supported by studies showing that when Hisx6
  tag was fused to the hinge of the S domain via a linker, fusion proteins self-formed into the S<SUB>60</SUB> nanoparticles.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">This has also been demonstrated by constructing a chimeric,
  and reconfirmed by cyroEM density map, S<SUB>60</SUB> nanoparticle displaying 60 RV (rotavirus) VP8* proteins, the major rotavirus neutralizing
  antigen. The S<SUB>60&nbsp;</SUB>-VP8*particles can be easily produced with high stability. The chimeric nanoparticle induced higher
  immunoglobulin, or IgG, response in mice (n=6) toward the displayed VP8*antigen than soluble VP8* antigen. Mouse sera experiments were
  completed analyzing vaccinated versus the control group to show neutralizing activity against RV infection. The statistical differences
  between the groups are (*P &lt; 0.05, **P &lt; 0.01, ***P &lt; 0.001) as shown below (Figure 2) (Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The RV surface spike protein, VP8* was tested for feasibility
  of the S<SUB>60</SUB> nanoparticle by the analysis using EM micrograph examination and ESI-MS analysis. S<SUB>60</SUB>-VP8*particles
  exhibited stronger blockade in mice (n=6) sera after vaccination (P=0.0003) (Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The polyvalent B- and T-cell epitopes of the antigens on
  the polyvalent VLP platform led to induction of stronger humoral and cellular immune responses, respectively, in animals and humans compared
  with those elicited by the monovalent epitopes of the free antigen. Thus, the polyvalent VLP platform is likely to increase the immunogenicity
  of the displayed antigens. Mouse sera experiments were completed analyzing vaccinated versus the control group to show neutralizing activity
  against RV infection. The statistical differences between the groups are (*P &lt; 0.05, **P &lt; 0.01, ***P &lt; 0.001) as shown below.
  (Xia et al. ACS Nano 2018, 12, 10665&minus;10682).</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><IMG SRC="image_004.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 2. </B>S<SUB>60</SUB>-VP8*particles
  enhanced immunogenicity toward the displayed RV VP8*antigens. The same dose/dosage of the S<SUB>60</SUB>-VP8*particles, free VP8*antigens,
  and S<SUB>60</SUB> nanoparticles without VP8*was given to mice (N=6), respectively, followed by measurements of theVP8*-specific IgG responses
  (A), 50% blocking titers (BT50) against RV VP8*-glycan ligand interaction (B), and neutralization activity against RV infection/replication
  in culture cells (C)&nbsp;of the resulting mouse antisera. (A)&nbsp;VP8*-specific IgG responses/titers elicited by theS60-VP8*particles,
  free VP8*antigens, and the S60nanoparticles, respectively. (B)&nbsp;BT50against RV VP8*&minus;ligand interactions by the mouse sera after
  vaccination with the same three immunogens, respectively. (C)&nbsp;Neutralizing activity against RV infection/replication in culture cells
  by mouse sera after immunization with the same three immunogens, respectively. In all these experiments mouse sera after immunization
  with diluent (PBS) are used as negative controls.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>The P<SUB>24</SUB> Nanoparticle as a versatile platform (Tan et
  al. Nanomedicine, 2012. 7.6,1-9)</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The crystal structure of norovirus VLPs indicates
  that P domain is involved in strong dimeric interactions forming dimeric protrusions on the viral surface. The oligomeric interactions
  of the P domains are also observed at the five-fold axes to further stabilize the capsid structure. When the P domain protein was expressed
  using the <I>E.&nbsp;coli</I> system, it self-assembled into P dimers, as well as 24 valent P nanoparticles, P<SUB>24</SUB>. P dimers
  and P<SUB>24</SUB> nanoparticles can exchange dynamically, depending on concentration of the P domain protein, indication that the assembled
  P<SUB>24</SUB> particles at this stage were unstable and easy to disassemble back into P dimers. To facilitate P<SUB>24</SUB> nanoparticle
  formation, inter-P domain disulfide bonds were introduced through fusion of a cysteine-containing peptide to the end of the P domain.
  During the P<SUB>24 </SUB>nanoparticle assembly, the cysteine patches were brought to the center of the P<SUB>24</SUB>&nbsp;nanoparticles,
  resulting in sterically close contact and thus forming inter-P domain disulfide bonds that significantly stabilized the P<SUB>24</SUB>
  nanoparticles, which could no longer disassemble back into the P dimers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">P<SUB>24</SUB> nanoparticles can be produced using an <I>E.
  coli</I> expression system faster and a lower cost than VLPs.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">Both VLP and P<SUB>24</SUB> nanoparticles without adjuvant
  produce innate, humoral, and cellular immunity.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: justify">The platform can be used to display foreign antigens, epitopes
  and viral pathogens and non-infectious disease.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">Studies have demonstrated immune response against flu, rotavirus,
  and norovirus using bi- or trivalent vaccine candidates developed using this approach, noting the potential for the development of a
  universal flu vaccine. Pre-clinical studies in influenza and rotavirus are provided below supporting our vaccine candidate programs.
  See&nbsp;&mdash;&nbsp;<I>Our Infectious Disease Vaccine Candidates</I>.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Our Infectious Disease Vaccine Candidates</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Infectious diseases are one of the leading causes
  of death worldwide. Infectious disease is caused by microorganisms or pathogens, including viruses, bacteria, fungi, and parasites that
  infect an individual and cause disease. Diseases often cause high fever, inflammation, or other symptoms. While some diseases can be treated
  with drugs or therapeutics, some infectious agents evolve to become resistant to commonly used drugs, such as antibiotics, and can become
  difficult to control. Infectious diseases can be passed from person to person or transmitted by insects or other animals. In many cases,
  vaccines are used to elicit a protective immune response in the absence of an infection to render an individual immune to a particular
  infectious disease.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101: UNIVERSAL INFLUENZA&nbsp;&amp; BWV-102 H1 INFLUENZA</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The company&rsquo;s lead vaccine programs are
  focused on developing transformational and novel influenza vaccines: BWV-101 for an influenza vaccine to provide protection against H1,
  H3 and Flu B infections; and BWV-102 for a H1 only vaccine. This program is licensed from the University of Oxford in which all relevant
  studies were performed to support our hypothesis. Our goal is to develop a vaccine that protects against all influenza strains that commonly
  infect humans by targeting specific parts of the influenza viruses, which are of limited variability across flu strains and induce a strong
  protective immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1,
  H3 and influenza B.&nbsp;The BWV-101 vaccine candidate may potentially provide a therapeutic benefit that negates the need for annual
  vaccination, vaccine reformulation, and provide long-lasting broad protection against the flu to millions globally (Thompson et al. Nature
  Communications. 2018. 9:385).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Influenza</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Influenza is a viral infection of the respiratory
  system, causing an infected person to suffer from certain symptoms, including fever, muscle aches, runny nose, cough, congestion, headaches,
  and fatigue. The four types of influenza viruses include type A, B, C, and D.&nbsp;The type A and B influenza viruses are referred to
  as human influenza viruses that are primarily responsible for seasonal flu epidemics each year. Type A flu viruses are further divided
  into two subtypes, named based on differences in two viral surface proteins called hemagglutinin (H)&nbsp;and neuraminidase&nbsp;(N).
  Influenza types C and D present a lower priority for vaccination, as Type C viruses cause a mild respiratory illness in humans and has
  not been associated with human epidemics, and Type D viruses primarily affect cattle and are not known to cause illness in humans (<I>https://www.cdc.gov/flu/about/viruses/types.htm</I>).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_005.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 3. </B>This graphic shows influenza
  virus types including the two types of influenza viruses (A,B) that cause most human illness and that are responsible for the flu season
  each year. Influenza A viruses are further classified into subtypes, while influenza B viruses are further classified into two lineages:
  B/Yamagata and B/Victoria.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is a major unmet need for the development
  of a novel universal flu vaccine as a prophylactic therapy. Influenza is a major respiratory pathogen. The WHO estimates there are an
  estimated 1&nbsp;billion cases of influenza infection with&nbsp;3-5&nbsp;million severe cases and 290,000-650,000 related respiratory
  human deaths worldwide every year. The estimate does not take into account deaths from other diseases such as cardiovascular disease,
  which can be influenza related. The next influenza pandemic is believed by many experts to be a potentially devastating global health
  threat. Influenza mortality rates are highest for the very young and elderly.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The global influenza vaccine market was valued
  at $3.96&nbsp;billion in 2018, and is projected to reach $6.20&nbsp;billion by 2026, representing a CAGR of 5.9% from 2019 to 2026. Currently,
  the standard of care and most effective protection against flu is through annual vaccination. The WHO estimates that worldwide, approximately
  $4&nbsp;billion is spent on influenza vaccines annually. However, the flu also a major cause of work absenteeism, leading to an estimated
  annual productivity loss in the U.S.&nbsp;of $87&nbsp;billion. Flu vaccination consists of a yearly injection of attenuated or inactivated
  (dead) influenza viruses to induce humoral immunity in the form of the antibodies against the current circulating or anticipated seasonal
  influenza strains. The induction of antibody-producing B-cells through vaccination allows the immune system to defend the body against
  the influenza virus circulating during the winter&nbsp;months.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">An annual seasonal flu vaccine is the best way
  to help protect against flu. Vaccination has been shown to have many benefits including reducing the risk of flu illnesses, hospitalizations
  and even the risk of flu-related death in children. The CDC recommends use of any licensed, age-appropriate influenza vaccine during the&nbsp;2020-2021
  influenza season, including inactivated influenza vaccine (IIV), recombinant influenza vaccine (RIV), or live attenuated influenza vaccine
  (LAIV). No preference is expressed for any influenza vaccine over another. Both trivalent and quadrivalent influenza vaccines will be
  available. The trivalent vaccines formulation will include A(H1N1) pdm09, A(H3N2) and B/Victoria. The quadrivalent vaccine formulations
  will include A(H1N1) pdm09, A(H3N2) and B/Victoria, plus B/Yamagata (<I>https://www.cdc.gov/flu/about/viruses/types.htm</I>).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The current influenza vaccines induce antibodies
  that target regions of the virus that are highly variable and have serious shortcomings, as they:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(i)</TD><TD STYLE="text-align: justify">must be administered annually,</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(ii)</TD><TD STYLE="text-align: justify">typically provide protection to only 50% of the individuals
  who receive it; and</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(iii)</TD><TD STYLE="text-align: left">need to be updated annually and reformulated 6&nbsp;months
  prior to influenza season, such that strains that are subsequently prevalent during the applicable &ldquo;flu season&rdquo; are not protected
  against by the vaccine.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Proprietary Epitope Discovery</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Using the technology that we have exclusively
  licensed from the University of Oxford, we are developing a universal influenza vaccine. Our exclusive license agreements include patented
  influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered
  by Dr.&nbsp;Sunetra Gupta and her team at the University of Oxford. We have acquired intellectual property for cross-protective epitopes
  to be used for our vaccine candidates that were developed and identified through a unique computational discovery process at Oxford University.
  The data produced through computational analysis at Oxford has shown that antigen evolution in influenza is limited to certain regions
  of the virus that facilitate binding and entry to host cells and these regions of limited antigenic variability are naturally immunogenic
  and therefore may be used to develop universal immunity to influenza viruses. We have identified epitopes of limited variability in H1
  influenza that have circulated throughout history (since 1918) and make ideal vaccine targets and have completed similar analysis of H3
  and Flu B strains for similar epitopes which will be used to produce our lead vaccine candidate BWV-101 as a universal vaccine for influenza
  infection. Due to the cross-reactive nature of the H1 epitopes in pre-pandemic H1 influenza A, we are also pursuing the development of
  a stand-alone H1 vaccine (BWV-102). These epitopes are able to be formulated into a vaccine candidate using our VLP platform technologies
  and may be evaluated using other vaccine technologies through partnerships in order to accelerate development of potential vaccines or
  to explore adjunct therapies (Thompson et al. Nature Communications. 2018. 9:385).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_006.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Figure 4.</B> Current influenza vaccine targets.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Antigenic Drift (Thompson et al. Nature Communications. 2018. 9:385)</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A single conformational epitope is typically 8
  to 15&nbsp;amino acids in length and in an extreme circumstance (where every change creates an escape mutant), a single epitope could
  theoretically vary from 208 to 2015 different ways. Therefore, a highly variable virus like influenza should be able to mutate in countless
  ways during each subsequent season. This would inevitability lead to an explosion of genetic diversity and numerous circulating strains.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
  <!-- Field: Page; Sequence: 25; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">However, it seems that there is a constraint limiting
  how influenza evolves, leading to a single or limited number of strains dominating each season. In 2007, Sunetra Gupta led a group of
  researchers at the University of Oxford who published a proprietary mathematical model proposing that the single strain dominance, typically
  seen worldwide annually, could be explained by hypothesizing that epitopes of &lsquo;limited variability&rsquo; exist (Antigenic Drift
  Hypothesis). The model hypothesizes that while there is a significant amount of mutation of influenza strains, this variability occurs
  in a specific portion of the virus, while certain epitopes are required to remain relatively constant and are more limited in their variability
  in order for the virus to infect individuals, thus clarifying how influenza is not as variable as commonly thought.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Antigenic Drift Hypothesis Illustration</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_007.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><B>Figure 5. </B>Identification of a site of limited
  variability in the head domain of the H1 HA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>b,c</I></TD><TD STYLE="text-align: left">Location of ABS of lowest variability containing position
  147 with position 147 shown in yellow and the rest of the site colored in red.</TD>
  </TR></TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="text-align: left; width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left"><I>d</I></TD><TD STYLE="text-align: left">Phylogenetic trees of pre-pandemic and post-pandemic highlighted
  rectangle H1N1with tips colored according to the conformation of the epitope of limited variability (hereafter called OREO). Please note
  the re-introduction of H1N1influenza in 1977 involved a strain which previously circulated in 1949/50.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">The Antigenic Drift Hypothesis suggests the existence
  of epitopes of limited variability mediate a population&rsquo;s immunity to influenza strains. As a particular influenza strain circulates
  in the population, immunity to a specific pattern of epitopes is induced. This leads the virus to change its antigenic configuration and
  cycle through its limited repertoire of antigenic conformations. However, population immunity also changes due to birth and death within
  the population (i.e. individuals in the population who had experienced and developed immunity to certain conformations die). This allows
  prior epitope conformations to reappear. The loss of herd immunity to these epitope of limited variability causes the emergence of epidemics
  (<I>Thompson et al. Nature Communications. 2018. 9:385</I>).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
  <!-- Field: Page; Sequence: 26; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Oxford scientists have identified the naturally
  antigenic regions that drive immunity to influenza by evaluating serum from these from various age groups of humans using assays and ELISAs
  reveal periodic cross-reactivity to ELV.&nbsp;Pseudotype microneutralisation data reveals a cyclical pattern of epitope recognition. The
  studies of children&rsquo;s sera were used to detect antibodies and demonstrated that young children ages 6 to 12 had immunity to historical
  influenza strains that circulated many&nbsp;years prior to when they were born and they could never have possibly been exposed to, one
  of which that last circulated in 1934. Mutagenesis of the identified regions of limited variability in various historical viruses removed
  the protective immunity. Furthermore, vaccination of mice, as shown below, with these regions of the influenza virus produced an identical
  immune response that was observed in the children. For example, the mice vaccinated with either the region from the influenza virus circulating
  in 2006 or 1977 were protected against infection with an influenza with a virus that last circulated in 1934, replicating the immunity
  seen in children ages 6 to 12. (Thompson et al. Nature Communications. 2018. 9:385)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_008.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <!-- Field: Page; Sequence: 27; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_009.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 6. </B>Sequential vaccination using
  chimeric HA constructs. Five groups of mice were sequentially vaccinated with 2009-like (blue), 2006-like (red),1995-like (orange), 1977-like
  (green) and 1940-like (pink) epitope sequences substituted into H6, H5 and H11 Has. Two further control groups were sequentially vaccinated
  with H6, H5 and H11 constructs without any sequence substituted into the Has (vaccinated controls). Further two groups were mock vaccinated
  (unvaccinated controls). <I><SUP>c,d,f,g</SUP></I>Pseudotype microneutralisation assays using 0.5&mu;l of sera from the bleed at 21&nbsp;weeks.
  Error bars are mean &plusmn; s.e.m.n=6 for experimental groups and control groups. The values provided are an average of two replicates</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This work demonstrated that vaccination with just
  four variants of one region of limited variability in H1 influenza was able to elicit immunity to all historical H1 influenza strains.
  As these regions periodically reappear and disappear over time, vaccination with all of the possible variants would be expected to provide
  protection against future influenza strains as well. The identified epitopes are restricted in their variability due to presence of a
  receptor-binding site and small alpha helix structure between disulphide bonds.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
  <!-- Field: Page; Sequence: 28; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The following research findings form the basis
  for our influenza vaccine candidates:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">1.</TD><TD STYLE="text-align: justify">Epitopes of limited variability which are under strong immune
  selection exist within influenza.</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">2.</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">These epitopes drive the antigenic evolution of influenza.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">3.</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">These epitopes cycle between a limited number of different conformations.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">4.</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">Epitopes of limited variability would make ideal vaccine targets.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-101: Universal Influenza Vaccine</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our approach to developing a novel, universal
  flu vaccine for the prevention and protection against human influenza strains and potential pandemic strains by targeting specific limited
  variability epitopes includes the following steps and processes.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exploring development of an influenza vaccine
  utilizing both the S&nbsp;&amp; P nanoparticles to determine the most effective and efficient presentation of our ELVs and the versatile
  S&amp;P nanoparticle vaccine platform from CHMC with the H1 influenza antigens. Data in preclinical mice (Rotavirus-specific-antibody-free
  BALB/c mice, n=5-7) challenge studies inserted M2e, a spike protein of influenza, into a P-particle loop; showed mice that were vaccinated
  had 100% protection when injected with lethal doses of influenza (Tan et al. JOURNAL OF VIROLOGY, Jan. 2011, p. 753&nbsp;&ndash;&nbsp;764).
  This dual approach will allow us to gain valuable information as we further the development and manufacturing of the BWV-102 program and
  utilize it for the development of BWV-101. We are currently assessing the ELVs to determine the most effective and efficient route of
  antigen presentation. Additionally, we are currently optimizing antigens for H3 and Flu B to be included with the identified H1 antigens
  to finalize our universal influenza vaccine formulation.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are using established manufacturing methods,
  including <I>E.coli</I> fermentation to produce our chimeric proteins, to reduce the cost and increase the efficiency and scalability
  of our manufacturing process for the vaccine. The antigens will be displayed by a proprietary virus-like particle (VLP) that can be produced
  in <I>E.&nbsp;coli</I> (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472). Our research and discovery model uses bioinformatics
  and phylogenetic analysis to identify possible sites of epitopes of limited variability before confirming their existence experimentally.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To date, we have identified naturally immunogenic
  epitopes for H1, H3 and influenza B.&nbsp;Bioinformatics studies and wet lab studies suggest that these epitopes, especially H1N1, and
  the chimeric scaffold configuration of our vaccine induce immunity due to induction of broad cross-reactive antibodies in other strains
  such as H10N3 (bird flu), and pandemic strains including H5NX, H7NX, and H9NX.&nbsp;H9NX (Thompson et al. Nature Communications. 2018.
  9:385). Therefore, we foresee the development of H1N1 vaccine as a priority due to its high cross-reactive priorities.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-102 Stand-Alone H1 Vaccine</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing our H1 stand-alone influenza
  prophylactic product, BWV-102, to address potential pandemic zoonotic H1 strains, specifically the G4 EA H1N1 identified by scientists
  and reported in June&nbsp;2020, as a potential next pandemic strain. BWV-102 is being developed using the H1 ELVs identified by the team
  at the University of Oxford. While the product is designed to protect against infection from any H1 strain, there is potential for cross
  protection from H5 and H10 strain infections as well. Preclinical studies were conducted in Balb C mice (n=6) using a prime-boost-boost
  protocol (Thompson et al. Nature Communications. 2018. 9:385). The proposed Phase&nbsp;I clinical study will employ this prime&nbsp;&mdash;&nbsp;boost
  protocol; however, it is possible that a single dose of the vaccine candidate will confer protection against current and historical H1
  strains with a prime-boost dose or a single dose.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As reported in 2020, the G4 EA H1N1 strain is
  the most prevalent influenza strain circulating among swine populations in China. The strain was first identified in 2016 and has been
  monitored by scientists in China through their swine surveillance program. The strain has genes from a mix of pig, avian and human viruses,
  including genes from the 2009 H1N1 flu pandemic virus. Currently, the G4 EA H1N1 strain is not transmissible human to human, however,
  scientists hypothesize that there is a high likelihood of strain reassortment occurring that could make human to human transmissibility
  possible. The current H1N1 influenza strain circulating may provide some protection against disease induced by G4 EA H1N1 infection.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ability of the BWV-102 ELVs to induce an immune
  response and protection against heterologous challenge with historical strains was assessed in Balb-C mice (n=6) (<I>Thompson et al. Nature
  Communications. 2018. 9:385</I>). We are currently assessing the ELVs in combination with the S<SUB>60</SUB> particle, P<SUB>24</SUB>
  particle and a proprietary VLP, currently in development, to determine the most effective and efficient route of antigen presentation.
  Manufacturing of the product is expected to occur in <I>E. coli (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472)</I>.
  We anticipate results of the VLP presentation assessments in the first half of 2022.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-201 Streptococcus pneumoniae (S. pneumoniae) Vaccine</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our BWV-201 vaccine candidate is a live attenuated
  serotype-independent vaccine, for which early data supports further investigation to pursue a long-term preventive intranasal vaccine
  for <I>S. pneumoniae</I> induced acute otitis media, or AOM.&nbsp;We in-licensed the novel live attenuated <I>S. pneumoniae</I> strain
  from St. Jude Children&rsquo;s Research Hospital, or St. Jude, as a potential serotype independent vaccine.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The potential of this vaccine to provide a long-term,
  leading alternative treatment for AOM and subsequent introduction of a novel preventative standard of care. The development of a novel
  vaccine could eradicate potential short-term pain and/or long-term harmful side effects from contracting the virus. Complications from
  AOM include sensorineural hearing loss, or SNHL, in adults but are more relevant for the endangerment of children.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Researchers from St. Jude developed a strain of
  <I>S. pneumoniae</I> that contains greatly reduced virulence yet can transiently colonize the nasopharyngeal cavity, inducing immune responses
  to significantly decrease the incidence of AOM and sinusitis as demonstrated in animal models. Our vaccine production is a straightforward
  process, utilizing the entire novel attenuated bacterium with purification and concentration steps only in the downstream process, thereby
  reducing the time and cost of production significantly compared to commonly used polysaccharide or conjugate vaccines.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Based on information from the American Academy
  of Pediatrics, over 5&nbsp;million cases of AOM are reported annually in the U.S., resulting in approximately 30&nbsp;million medical
  care visits and over 10&nbsp;million antibiotic prescriptions. AOM is the most common condition treated with antibiotics in the United&nbsp;States
  and increasing antibiotic resistance among the organisms responsible for AOM is of concern to researchers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additional statistics supporting the need for
  a novel preventive vaccine:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">&#9679;</TD><TD STYLE="text-align: left">The global AOM rate is 10.85%, or 709&nbsp;million cases
  per year, with 51% occurring in children under 5&nbsp;years old (Tong et al. BMC Health Serv Res. 2018; 18: 318).</TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">By 3&nbsp;years of age, 80% of children globally are expected to have at least one episode of AOM. (Vergison&nbsp;A, Lancet Infect Dis. 2010 Mar;10(3):195-203. Doi: 10.1016/S1473-3099(10)70012-8. PMID:&nbsp;20185098.).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">Current treatment for AOM is by antibiotic prescription, with more than 80% of all consultations resulting in a prescription. (Haggard, M.&nbsp;Eur J Pediatr 170, 323&nbsp;&ndash;&nbsp;332 (2011). <I>https://doi.org/10.1007/s00431-010-1286-4</I>).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">Even with the introduction of the pneumococcal conjugate vaccine (PCV13) in 2010,&nbsp;26-36% of cases of AOM in U.S.&nbsp;were caused by <I>S. pneumoniae.</I> (Casey JR, Kaur R, Friedel VC, Pichichero ME.&nbsp;Acute otitis media otopathogens during 2008 to 2010 in Rochester, New&nbsp;York. <I>Pediatr Infect Dis J</I>. 2013;32(8):805-809. Doi:10.1097/INF.0b013e31828d9acc).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">Worldwide cases of AOM due to <I>S. pneumoniae </I>is estimated to be&nbsp;30-50%. (Bergenfelz C, Hakansson AP.&nbsp;Curr Otorhinolaryngol Rep. 2017;5(2):115-124. Doi: 10.1007/s40136-017-0152-6. Epub 2017 May&nbsp;20. PMID: 28616365; PMCID:&nbsp;PMC5446555.).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">An estimated $4.3&nbsp;billion USD is spent on AOM treatment each year in the U.S.&nbsp;alone. (Tong S, BMC Health Serv Res. 2018 May&nbsp;2;18(1):318. Doi: 10.1186/s12913-018-3139-1. PMID: 29720156; PMCID:&nbsp;PMC5932897.).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The current standard of care treatment for AOM
  in children is reliant on antibiotics. The resolution rate of AOM in children is 81% without antibiotic treatment vs. 93% with antibiotic
  treatment. Antibiotic treatment of AOM in children has limitations, including recurrence within 30&nbsp;days.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CDC recommends broad pneumococcal vaccines
  for children younger than 2 and for adults over 65&nbsp;years of age (CDC). The CDC also recommends vaccinations for children and adults
  age 2 through 64 either previously unvaccinated or partially vaccinated. Two vaccines are currently approved in the U.S.&nbsp;and other
  countries: Prevnar13 or PCV13 (Pfizer) (ii)&nbsp;Pneumovax or PPSV23 (Merck). An additional vaccine, Synflorix, is for approved use outside
  of the U.S.&nbsp;for the prevention of pneumococcal disease and <I>S. pneumoniae</I> induced AOM for the 10 serotypes included in the
  vaccine.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Therefore, an effective serotype independent <I>S.
  pneumoniae</I> AOM vaccine could significantly impact pediatric healthcare demand. As a preventative treatment, the vaccine&rsquo;s advantages
  include: reduction of near-term pain; reduction of recurrent AOM that may result in the need for tympanostomy tube placement; lessening
  of antibiotic usage, which would decrease the number of antibiotic resistant organisms in the environment; and avoiding potential long-term
  hearing loss.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Previous live, attenuated strains of S. pneumoniae
  were generated by deleting several highly immunogenic virulent genes and therefore may not be optimal vaccine candidates. Some of these
  deletions include antigens that induce antibody responses following pneumococcal carriage and otitis media in young children and therefore
  may not be optimal vaccine candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our technology in-licensed from St. Jude focuses
  on candidate genes essential for microbial adaptation to the host environment while maintaining virulence determinants. The St. Jude researchers
  developed a <I>S. pneumoniae strain</I> with a deletion in <I>ftsY</I>, a central component of the signal recognition pathway (SRP). SRP
  mutants have greatly reduced virulence, although virulence factors are still produced. The <I>S. pneumoniae ftsY</I> deletion strain may
  potentially make an ideal live attenuated vaccine, as it can transiently colonize the nasopharyngeal cavity without inducing immune responses
  to virulence protein antigens but does not cause invasive disease.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our candidate vaccine is a live attenuated serotype-independent
  vaccine, that early data supports further development to pursue a potential long-term preventive intranasal treatment. BWV-201 will likely
  require two doses to provide life-long protection. BWV-201&rsquo;s has the ability to transiently colonize the nasopharyngeal cavity and
  significantly decrease the incidence of AOM and sinusitis in animal models. The vaccine candidate is derived from the noninvasive serotype
  19F strain BHN97, which normally causes sinusitis/purulent rhinitis and AOM.&nbsp;As previously noted, the <I>ftsY</I> gene was deleted
  by St. Jude researchers, and is designated BHN97<FONT STYLE="font-family: Symbol">&otimes;</FONT>ftsY (Rosch, Jason W et al. EMBO molecular
  medicine vol. 6,1 (2014):&nbsp;141-54. Doi:10.1002/emmm.201202150).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our vaccine production is a straightforward approach,
  utilizing the entire bacterium with purification and concentration steps only in the downstream process thereby significantly reducing
  the time and cost of production compared to polysaccharide or conjugate vaccines.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Preclinical data colonization and invasiveness and Otitis Media/Sinusitis
  Efficacy</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our pre-clinical data has shown encouraging results
  from the research and development of BWV-201 as a potential intranasal delivered vaccine candidate. Multiple animal models have demonstrated
  protection from AOM.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To demonstrate vaccine efficacy against AOM and
  sinusitis, mice were immunized (prime and two boosts) with Prevnar 7 (PCV7), Prevnar 13 (PCV13), Pneumovax (PCV23), D39x and BHN197 caxP
  and ftsY deletion mutants. Deletion of ftsY, a central component of the signal recognition particle (SRP) pathway show heightened sensitivity
  to environmental stress and have greatly diminished virulence. Deletion of caxP, a calcium/magnesium transporter, renders host physiological
  conditions in blood and mucosa toxic to the bacterium. BHN97ftsY serotype 19F is also characterized in PCV7, PCV13, and PCV23 (Rosch,
  Jason W et al. EMBO molecular medicine vol. 6,1 (2014):&nbsp;141-54. Doi:10.1002/emmm.201202150).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">This head-to-head preclinical study mice (n=25-31)
  that were either vaccinated by mock or live attenuated with deletions of either type 2 or 19F backgrounds. This was challenged by bioluminescent
  BMH97X twice daily for AOM and sinusitis. Histopathology was also used to analyze the ears of mice. Xenogen imaging PPV23 was used as
  a negative control.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Two&nbsp;weeks following the second boost, the
  bioluminescent strain BNH97x (type 19F), a serotype included in Prevnar 7, Pneumovax and BHN97ftsY (referred to as homologous challenge)
  were introduced to the mice. Only BHN97&#8710;ftsY (BWV-201), and to a lesser extent Prevnar 7, showed significant reduction in AOM and
  only BHN97&#8710;ftsY demonstrated significantly reduced sinusitis compared to mock infected animals. The incidence of AOM was significantly
  (<I>p</I> &lt;0.05 compared to mock) lower in BHN97&#8710;ftsY&nbsp;&mdash;&nbsp;vaccinated mice (Figure&nbsp;A-below). Only BHN97&#8710;ftsY
  vaccine significantly decreased the incidence of sinusitis (<I>p</I> &lt; 0.05). Measurement of luminescence at 24 and 72 h confirmed
  protection engendered by BHN97&#8710;ftsY.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_010.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 7. </B>Vaccine protection against otitis
  media and sinusitis. Mice (n=25&nbsp;&ndash;&nbsp;31 per group, performed at least twice for each group) were mock-vaccinated with PBS
  (Mock) or vaccinated with live attenuated vaccines deleted for caxP or ftsY on either a type2 (D39&#8710;caxP, D39<FONT STYLE="font-family: Symbol">&otimes;</FONT>ftsY)
  or type19F (BNH97&#8710;caxP, BNH97&#8710;ftsY) background. Mice were challenged with a bioluminescent <I>S. pneumoniae</I> strain BNH97X
  (type19F) and imaged twice daily for development of AOM or sinusitis. A.&nbsp;The proportion of mice developing an infection of the ear
  or sinus by Xenogen imaging. * =p&lt;0.05 by Chi-squared test compared to the mock vaccinated group. PPV23 was used as a negative control
  (60% otitis and 80% sinusitis). Errors bars represent standard error of the mean. PCV7 is Prevnar 7, PPV23 is Pneumovax and BHN97&#8710;ftsY
  is BWV-201.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To determine if BHN97&#8710;ftsY, or BWV-201,
  (serotype 19F) can induce heterotypic AOM protection (AOM caused by a <I>S. pneumoniae </I>serotype not contained in the vaccine), mice
  (n=20) were immunized as detailed above and challenged with BHN54 (serotype 7), which causes otitis media in about 50% of challenged animals.
  The control vaccine Prevnar 13 contains serotype 7; therefore, this study compares heterotypic (BHN97&#8710;ftsY) versus homotypic (Prevnar
  13) vaccine protection. BHN97&#8710;ftsY had a 10-fold lower incidence of AOM, (*p &lt; 0.05) when compared to mock immunized animals,
  demonstrating that the attenuated vaccine does induce heterotypic protection. Bioluminescent signaling as well as, reduction in weight
  loss also demonstrated secondary analysis supporting vaccine protection.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">BHN97&#8710;ftsY induced protection from AOM was
  additionally confirmed in a chinchilla (n=20) animal model. The animals were immunized (prime and two boosts) and then challenged with
  BHN97 two&nbsp;weeks after the final boost. Vaccinated animals had a decreased incidence of culture-positive ears and had a significantly
  decreased number of recoverable bacteria from the middle ear (A). Following vaccination, a reduction in the number of culture positive
  ears in vaccinated group compared to the mock animals was observed (B)&nbsp;as well as significant reduction in recoverable CFUs from
  middle ear 7&nbsp;days post challenge (C)&nbsp;* = p &lt; 0.05 by Mann&nbsp;&mdash;&nbsp;Whitney.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_011.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 8. </B>Vaccine protection in a chinchilla
  model of otitis media. The BHN97strain is capable of causing otitis media in chinchillas via intranasal administration as observed by
  recoverable bacterial colony forming units (CFUs) from the middle ear (A)&nbsp;following challenge. B, C Following vaccination with BHN97
  &#8710;ftsY (BWV-201), a reduction in the number of culture positive ears in the vaccinated group compared to the mock animals was observed
  (B)&nbsp;as well as a significant reduction in recoverable CFUs from the middle ear at 7days post challenge (C). *&nbsp;=p&lt;0.05by Mann&nbsp;&mdash;&nbsp;Whitney.
  Vaccine is BHN97 &#8710;ftsY (BWV-201).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A potential advantage of an attenuated <I>S. pneumoniae
  </I>vaccine such as BHN97&#8710;ftsY is that immune responses are directed to bacterial proteins rather than just polysaccharides and
  should not be limited to serotype specific protection. Purified polysaccharide (PPV) vaccines such as Pneumovax (produced by Merck&nbsp;&amp;Co.)
  and pneumococcal conjugate vaccines such as Prevnar 7/13/20 (produced by Wyeth/Pfizer) or Synflorix (produced by GlaxoSmithKline plc)
  are generally considered serotype specific, inducing protection to disease caused only by pneumococcal strains contained in the vaccines.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-301 Norovirus-Rotavirus Vaccine Program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are developing BWV-201 to prevent acute gastroenteritis,
  or AGE, caused by norovirus and rotavirus, utilizing the P<SUB>24</SUB> nanoparticle of our vaccine platform. The vaccine is based on
  one or two doses of the norovirus P<SUB>24</SUB> nanoparticle presenting 24 rotavirus VP8* antigens. Most cases of gastroenteritis are
  caused by viruses. The CDC reports that viral gastroenteritis infections cause 200,000 deaths in children worldwide each year. Common
  symptoms of viral gastroenteritis causes nausea, vomiting, diarrhea, anorexia, weight loss, and dehydration.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Gastroenteritis</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Gastroenteritis, often called stomach flu, is
  inflammation of the gastrointestinal tract&nbsp;&mdash;&nbsp;the stomach and intestine. Symptoms may include diarrhea, vomiting and abdominal
  pain. Fever, lack of energy and dehydration may also occur. While gastroenteritis is usually caused by viruses, bacteria, parasites, and
  fungus can also cause gastroenteritis. Eating improperly prepared food, drinking contaminated water or close contact with a person who
  is infected can spread the disease. Norovirus and rotavirus are two viruses that cause gastroenteritis in adults and children.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In 2015, there were two billion cases of gastroenteritis,
  resulting in 1.3&nbsp;million deaths globally. Children and those in the developing world are affected the most. In 2011, there were about
  1.7&nbsp;billion cases, resulting in about 700,000 deaths of children under the age of five. In the developing world, children less than
  two&nbsp;years of age frequently get six or more infections a year. It is less common in adults, partly due to the development of immunity.
  In adults, norovirus is the most common cause of severe disease. Rotavirus, however, is the common cause of AGE in children.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Norovirus</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Norovirus causes significant debilitating AGE,
  with a reported 700&nbsp;million infections and 20% of all diarrheal cases reported annually worldwide, according to the CDC.&nbsp;About
  200&nbsp;million cases are seen among children under 5&nbsp;years old, leading to an estimated 50,000 child deaths every year. Norovirus
  is the cause of approximately 20% of all AGE cases worldwide each year. It is estimated that 68.9 cases of norovirus infection occur in
  every 1000 people. In North America, norovirus induced AGE tends to be seasonal, occurring in cooler, rainy&nbsp;months and particularly
  impacts groups in close proximity, such as in schools, dormitories, medical facilities, and cruise ships.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Norovirus costs $60.3&nbsp;billion worldwide each
  year (CDC). Globally, norovirus resulted in a total of approximately $4.2&nbsp;billion in direct health system costs and approximately
  $60.3&nbsp;billion in societal costs per year. Disease among children younger than 5&nbsp;years cost society $39.8&nbsp;billion, compared
  to $20.4&nbsp;billion for all other age groups combined. Costs per norovirus illness varied by both region and age and was highest among
  adults ages 55&nbsp;years and older. Productivity losses represented&nbsp;84-99% of total costs varying by region. While low and middle
  income countries and high income countries had similar disease incidence (10,148 vs. 9,935 illness per 100,000 persons), high income countries
  generated 62% of global health system costs (Bartsch et al. PloS One 2016; 11:e0151219).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In North America, the median yearly cost of outbreaks
  was $7.6&nbsp;million in direct medical costs, and $165.3&nbsp;million in productivity losses. An average of approximately 113,000 hospitalizations,
  8.2-122.9&nbsp;million missed school/work&nbsp;days, $0.2-$2.3&nbsp;billion in direct medical costs, and $1.4-$20.7&nbsp;billion in productivity
  losses was due to sporadic illness. The total economic impact of norovirus infection was $10.6&nbsp;billion based on the current incidence
  estimate 68.9 cases per 1000 population, or approximately $0.15&nbsp;million per person infected.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The total economic burden is greatest in young
  children but the highest cost per illness is among older age groups in some regions. These large costs overwhelmingly are from productivity
  losses resulting from acute illness. Low, middle, and high income countries all have a considerable economic burden, suggesting that norovirus
  gastroenteritis is a truly global economic problem.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is not a norovirus vaccine on the market
  presently. There are, however, a number of rotavirus vaccines currently marketed around the world. RotaTeq, owned by Merck, a live, oral
  pentavalent vaccine and Rotarix, owned by GSK, a monovalent, human, live attenuated vaccine are recommended by the World Health Organization
  (WHO) for global use in children and approved for use in the U.S., Canada and Europe. Other monovalent vaccines are available but only
  approved for use in one country, either China, Vietnam or India.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">P<SUB>24</SUB> VLPs produced in <I>E. coli</I>
  and norovirus VP1 VLPs produced in a baculovirus expression system were both demonstrated to elicit innate, humoral and cellular immunity
  in a mouse model, indicating that both constructs have potential as norovirus virus candidates. In addition, when delivered intranasally
  both constructs were able to induce partial cross-variant protection against diarrhea in a gnotobiotic pig model. Ramesh et al. <I>Vaccines</I>
  2019, 7, 777.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Rotavirus</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Rotavirus is the most common cause of diarrheal
  disease among infants and young children, causing an estimated 111&nbsp;million episodes of diarrhea annually, 2&nbsp;million hospitalizations
  and 352,000-592,000 deaths annually, according to the CDC.&nbsp;After the introduction of live attenuated oral vaccines the incidence
  of rotaviral hospitalizations and deaths have significantly declined. However, there is still a need for efficacious, cost-effective rotavirus
  vaccines.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The rotavirus vaccine is recommended by the CDC
  and ACIP as a prevention for children. However, managing the symptoms is the only way to help adults and children infected with either
  of the viruses. Due to the potential of death, most treatments are focused on dehydration prevention and management. Treatment involves
  getting enough fluids. For mild or moderate cases, this can typically be achieved by drinking oral rehydration solution (a combination
  of water, salts and sugar). In those who are breastfed, continued breastfeeding is recommended. For more severe cases, intravenous fluids
  may be needed and care provided in the hospital. Fluids may also be given by a nasogastric tube. Zinc supplementation is recommended in
  children. Antibiotics are generally not needed. However, antibiotics are recommended for young children with a fever and bloody diarrhea.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To determine the potential of the P<SUB>24</SUB>
  VLP to serve as a rotavirus vaccine candidate, the 159&nbsp;amino acid VP8* protein was inserted into a P<SUB>24</SUB> domain surface
  loop. The fusion proteins self-assembled into P<SUB>24</SUB> VLPs, and the 24 rotavirus VP8* antigens were demonstrated by cryo-EM to
  be displayed on the outermost surface of the chimeric P<SUB>24</SUB> VLP.&nbsp;Mice (n-5-7) immunized intranasally with the P<SUB>24</SUB>-VP8*
  or intramuscularly with Freund&rsquo;s adjuvant elicited significantly higher rotavirus neutralizing antibodies than the free VP8* immunized
  under the same conditions (IN or IM). (P &gt;0.05), (Tan et al. J.&nbsp;Virol. 85(2):753-764. 2011.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">P<SUB>24</SUB>-VP8* VLPs were further characterized
  as a potential rotavirus vaccine in mouse and gnotobiotic pig challenge studies. A construct consisting of P<SUB>24</SUB> and the VP8*
  antigen from the murine rotavirus EDIM strain was constructed and tested using a murine rotavirus challenge model. Mice (n=5-7) were immunized
  with P<SUB>24</SUB>-mouseVP8*, mouseVP8* alone or P<SUB>24</SUB>-human VP8* 3 times intranasally without adjuvant. Rotavirus shedding
  was significantly lower in animals immunized with P<SUB>24</SUB>-mouseVP8* than mock vaccinated or animals that received mouseVP8* only
  or P<SUB>24</SUB>-humanVP8* * (P &gt;0.05) (Tan et al. J.&nbsp;Virol. 85(2):753-764. 2011).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, an immunogenicity study was conducted
  in gnotobiotic pigs (n=25). A construct of P<SUB>24</SUB> and the VP8* antigen corresponding to human rotavirus Wa strain was tested in
  a gnotobiotic pig challenge model. Animals were immunized intramuscularly (IM) three times with either P<SUB>24</SUB>-WuVP8* with luminium
  hydroxide adjuvant or luminium hydroxide alone and were challenged with human Wa rotavirus 7&nbsp;days post dose three. Animals immunized
  with P<SUB>24</SUB>-WuVP8* showed a significant reduction in the mean duration of diarrhea, virus shedding and significantly lower fecal
  cumulative consistency scores compared to adjuvant only control group (*, p &lt; 0.05; **, p &lt; 0.01). (Ramesh et al. Vaccines 7: 177
  2019; doi:10.3390/vaccines7040177).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_012.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 9. </B>.P24-VP8* vaccine protected against
  VirHRV diarrhea and reduced overall virus shed among vaccinated pigs. Fecal consistency (A)&nbsp;and virus shedding (B)&nbsp;were monitored
  daily from post challenge&nbsp;day (PCD) 1 to PCD 7 after the challenge with VirHRV.&nbsp;Fecal consistency scores&ge;2 were considered
  to be diarrheic (dashed line indicates the threshold of diarrhea). Statistical significance between vaccinated and control groups, determined
  by multiple t tests, are indicated by asterisks (*,p&lt;0.05; **,p&lt;0.01).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, serum samples were collected from
  the pigs at the times of P<SUB>24</SUB>-VP8* vaccine administration (PID&nbsp;0, PID&nbsp;10, PID21 and PID&nbsp;21) and VirHRV challenge
  (PID&nbsp;27) and upon euthanasia (PCD 7). The P<SUB>24</SUB>-VP8* vaccine was highly immunogenic in Gn pigs. It induced strong VP8*-specific
  serum IgG and Wa-specific virus-neutralizing antibody responses from post-inoculation&nbsp;day 21 to PCD 7. Comparisons between groups
  at the same time points were carried out using Student&rsquo;s t-test and significant differences are identified by *** (n = 10&nbsp;&ndash;&nbsp;15;
  p &lt; 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group, where different capital letters
  (A, B, C,D) indicate a significant difference, p &lt; 0.01, and shared letters indicate no significant difference. These findings support
  further investigation of the noro-rotavirus dual nanoparticle vaccine. (Ramesh et al. Vaccines 7: 177 2019; doi:10.3390/vaccines7040177)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_013.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 10. </B>Geometric mean VP8*-specific
  IgG (A)&nbsp;and IgA (B)&nbsp;and Wa-HRV neutralizing (C)&nbsp;antibody titers in serum collected from Gn pigs at PID&nbsp;0, 10, 21,
  28, and PCD 7. Pigs were vaccinated with P24-VP8* vaccine or Al(OH)3 adjuvant only. Each serum specimen was tested at an initial dilution
  of 1:4. Negative samples were assigned an arbitrary value of 2 for calculation and graphical illustration purposes. Comparisons between
  groups at the same time points were carried out using Student&rsquo;s t-test and significant differences are identified by&nbsp;*** (n
  = 10&nbsp;&ndash;&nbsp;15; p &lt; 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group,
  where different capital letters (A, B, C, D) indicate a significant difference, p &lt; 0.01, and shared letters indicate no significant
  difference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">An effective norovirus culture-based neutralization
  assay is not available, due to the lack of an efficient cell culture system to produce human norovirus. Therefore, a surrogate neutralization
  assay has been developed in the field, measuring the ability of antisera to block norovirus VLP binding to host receptors. In addition
  to generating rotavirus neutralizing antibody, Tan et al (J.&nbsp;Virol. 86:753-764. 2011) demonstrated that anti- P<SUB>24</SUB>-VP8*
  mouse sera blocked norovirus VLP binding, indicating that the insertion of the VP8* fragment did not inhibit induction of norovirus VLP
  binding antibodies and suggesting the P<SUB>24</SUB>-VP8 construct could potentially serve as a single vaccine against both rotavirus
  and norovirus disease (P &gt;0.05).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Vaccine</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We hold the exclusive global license for the novel
  norovirus-rotavirus combination vaccine (except in China and Hong&nbsp;Kong) from Cincinnati Children&rsquo;s Hospital Medical Center,
  or CHMC, CHMC researchers engineered the norovirus major structural protein VP1 such that the N-terminal shell (S)&nbsp;and C-terminal
  protruding (P)&nbsp;domains of VPI could be expressed as separate S<SUB>60</SUB> and P<SUB>24</SUB> virus-like particles (VLPs). Unlike
  norovirus VLPs composed of the intact VP1 protein or the unmodified S<SUB>60</SUB> fragment, our S<SUB>60</SUB> and P<SUB>24</SUB>VLPs
  can be expressed in <I>E. coli</I>. The researchers demonstrated that S<SUB>60</SUB> VLPs could be used to present foreign antigens on
  the surface of the S<SUB>60</SUB> VLP.&nbsp;Further, it has also demonstrated that foreign antigens could also be expressed on the surface
  of the P<SUB>24</SUB> VLP.&nbsp;The proposed norovirus-rotavirus vaccine is based on the P<SUB>24</SUB> VLP technology. Our vaccine production
  is based on an <I>E.coli</I> expression platform.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Following IND submission, if accepted, we intend
  to initiate our Phase&nbsp;I clinical trial in healthy adults ages&nbsp;18&nbsp;to 54. If approved, we believe our vaccine is well positioned
  to receive a recommendation from the CDC, ACIP, and similar international advisory groups for inclusion in vaccine programs.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>BWV-302: Norovirus-malaria vaccine program</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, we are currently investigating a
  malaria vaccine, BWV-302, utilizing our norovirus platform. The vaccine is designed to offer protection from both norovirus and malaria,
  infectious diseases that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of
  the plasmodium parasite being presented on the surface of the norovirus nanoparticle.</P>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Malaria</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Malaria can be a deadly disease caused by protozoan
  parasites from the Plasmodium family, primarily spread by mosquitos (CDC, <I>https://wwwnc.cdc.gov/travel/diseases/malaria)</I>. Malaria
  may also, at times, be transmitted through blood transfusion, organ transplantation and from mother to fetus. (CDC, <I>https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/malaria</I>).
  While transmission through blood transfusion is rare in the U.S., there are no approved blood tests currently available to screen blood
  donation for malaria. There were approximately 219&nbsp;million cases of malaria reported in 2019 globally, resulting in approximately
  409,000 deaths, of which approximately 67% were children. (WHO, <I>https://www.who.int/news-room/fact-sheets/detail/malaria</I>). Symptoms
  of malaria normally manifest themselves within 7 to 10&nbsp;days of exposure, and can at times, be mistaken for other illnesses, including
  influenza. Severe malaria is life-threatening and can cause multi-organ failure in adults and severe anemia, metabolic acidosis and cerebral
  malaria in children. The World Health Organization estimates that almost half of the global population is at risk of contracting malaria.
  Infants, children under 5&nbsp;years of age, pregnant women and immune compromised individuals are highest risk of developing the disease.
  Additionally, non-immune migrants, mobile populations and travelers are at risk of developing severe disease. Neurological issues in children
  may continue to persist after cerebral malaria, including ataxia, palsy, speech impairment, deafness and blindness.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_014.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">More than 100 species of Plasmodium have been
  identified. Four of the species have been recognized as naturally infecting humans, while one that infects macaques and has been identified
  as a cause of zoonotic malaria. In rare cases, additional species may infect humans. The primary four parasites that cause human infection
  are <I>P.&nbsp;falciparum, P. vivax, P. ovale and</I> (<I>https://www.cdc.gov/malaria/about/biology/index.html</I>). <I>P. knowlesi</I>
  is naturally occurring in macaques in Southeast Asia and has recently been reported as the cause zoonotic malaria, especially in Malaysia.
  <I>P. falciparum </I>is found world-wide, can cause severe malaria and is the predominate human malaria causing species around the world.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is currently one vaccine for malaria, RTS,S/AS01
  (MVI-GSK) targeting the falciparum CS protein, which received a positive opinion from the European Medicines Agency (EMA) for use outside
  of the European Union in infants 6&nbsp;weeks of age and older. (<I>https://www.ema.europa.eu/en/news/first-malaria-vaccine-receives-positive-scientific-opinion-ema</I>)
  According to the EMA, the World Health Organization and the relevant regulatory agencies for countries outside of the European Union can
  authorize its use. The vaccine is currently being administered to infants and children in parts of Africa within high transmission regions.
  The vaccine&rsquo;s efficacy appears to wane after five&nbsp;years (Laurens MB.&nbsp;RTS,S/AS01 vaccine (Mosquirix&trade;): an overview.
  <I>Hum Vaccin Immunother.</I> 2020;16(3):480-489. Doi:10.1080/21645515.2019.1669415). The recommended course of action for preventing
  malaria is prevention of mosquito bites, and for those most vulnerable, a preventative treatment with sulfadoxine-pyrimethamine, especially
  in high transmission areas (WHO). In certain regions, the WHO has recommended the addition of amodiaquine to children under 5&nbsp;years
  of age monthly during the high transmission season, along with sulfadoxine-pyrimethamine. Many regions employ mosquito control measures
  to reduce mosquito populations, however, 73 countries have reported mosquito resistance to at least 1 of the 4 most commonly used insecticides,
  while 23 countries have reported mosquito resistance to all of the commonly used insecticides.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once malaria is diagnosed, the two most common
  treatments are Chloroquine phosphate and Artemisinin-based combination (ACT) therapies. Chloroquine is the preferred treatment, however,
  some malaria parasites have become resistant to chloroquine and it may not be an effective treatment. ACT is a combination of two or more
  drugs that work against the malaria parasite in different ways. This is usually the preferred treatment for chloroquine-resistant malaria.
  However, as recently reported in Nature Medicine, there is growing concern about Artemisinin&nbsp;&mdash;&nbsp;derivative resistant P.falciparum
  in the Greater Mekong subregion (Cambodia, Thailand, Vietnam, Myanmar and Laos) (<I>https://www.nature.com/articles/s41591-020-1005-2.pdf</I>).
  Previous occurrences of resistant strains also first appeared in the Greater Mekong subregion and then spread to other parts of the world.
  (<I>https://www.nature.com/articles/s41591-020-1005-2.pdf</I>).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Our Vaccine</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We hold the exclusive global license for the novel
  norovirus-malaria combination vaccine from Cincinnati Children&rsquo;s Hospital Medical Center, or CHMC, CHMC researchers engineered the
  norovirus major structural protein VP1 such that the N-terminal shell (S)&nbsp;and C-terminal protruding (P)&nbsp;domains of VPI could
  be expressed as separate S<SUB>60</SUB> and P<SUB>24</SUB> virus-like particles (VLPs). Unlike norovirus VLPs composed of the intact VP1
  protein or the unmodified S<SUB>60</SUB> fragment, our S<SUB>60</SUB> and P<SUB>24</SUB>VLPs can be expressed in <I>E. coli</I>. The researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., demonstrated that S<SUB>60</SUB> VLPs could be used to present foreign antigens on the surface
  of the S<SUB>60</SUB> VLP.&nbsp;Further, it has also demonstrated that foreign antigens could also be expressed on the surface of the
  P<SUB>24</SUB> VLP. (see <B><I>BWV Norovirus (NoV) S&amp;P Nanoparticle Versatile Vaccine Platform</I></B>). The proposed norovirus-malaria
  vaccine, P-CS)TSR is based on the P<SUB>24</SUB> VLP technology. Our vaccine production is based on an <I>E.coli</I> expression platform.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The circumsporozoite (CS) protein is the major
  surface component of <I>P. falciparum</I> sporozoites and is essential for host cell invasion. Our vaccine, developed by Jiang and Ming
  from CHMC, combines a small domain of the CS protein with the norovirus P<SUB>24</SUB> particle creating a chimeric nanoparticle capable
  of eliciting an immune response. A mouse immunization study was conducted using the P<SUB>24</SUB> particle presenting the small domain
  of the CS protein. Mice (n=16) were immunized three times with the chimeric nanoparticle using aluminum hydroxide as an adjuvant, 3D7-His,
  3D7-GST and PBS.&nbsp;Sera was collected and evaluated.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">High antibody titers, as determined by ELISA,
  were observed after the second immunization and higher titers were observed after the third immunization. The antibodies were also shown
  to recognize the plasmodium falciparum 3D7 strain using immunofluorescence assays. These data demonstrate the potential of our vaccine
  candidate against malaria. We expect to conduct an animal challenge study to further analyze the protective nature of BWV-302 and support
  an IND application.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Table 3. Mouse malaria antibody titer post-immunization</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 50%; border-bottom: black 1.5pt solid; padding-right: 3pt; font-size: 10pt"><B>Antibody titer after 2<SUP>nd</SUP> immunization</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; font-size: 10pt">&nbsp;</TD>
      <TD STYLE="width: 49%; border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center"><B>Antibody titer after 3<SUP>rd</SUP> immunization</B></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_015.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B>Figure 11. IFA of plasmodium sporozoites (3D7)
  stained with anti-P<SUB>24</SUB> particle presenting the small domain of the CS protein mouse sera</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><IMG SRC="image_016.jpg" ALT="">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We anticipate conducting an animal challenge study
  for BWV-302 in the second half of 2023. Upon completion, the technology will be transferred to a partner CDMO for process optimization,
  GMP production and toxicology studies, as well as other studies required by the FDA for IND submission.Following IND submission immediately
  upon completion of the toxicology study, if successful, we intend to initiate our Phase&nbsp;I clinical trial in healthy adults ages 18
  to 54 upon acceptance by the FDA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Government Regulation and Product Approval</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA and other regulatory authorities at federal,
  state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
  manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
  advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those we are developing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Small molecule drugs are subject to regulation
  under the Food, Drug, and Cosmetic Act, or FDCA, and biological products are additionally subject to regulation under the Public Health
  Service Act, or PHSA, and both are subject to additional federal, state, local and foreign statutes and regulations. We, along with third-party
  contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory
  agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>United&nbsp;States</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>U.&nbsp;S. Biopharmaceuticals Regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The process required by the FDA before drug and
  biologic product candidates may be marketed in the United&nbsp;States generally involves the following:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">completion of extensive preclinical laboratory tests and animal studies performed in accordance with applicable regulations, including the FDA&rsquo;s Good Laboratory Practice, or GLP, regulations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">submission to the FDA of an investigational new drug application, IND, which must become effective before clinical trials may begin;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">approval by an independent institutional review board or ethics committee at each clinical site before the trial is commenced;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">performance of adequate and well-controlled human clinical trials in accordance with FDA&rsquo;s Good Clinical Practice, or GCP, regulations to establish the safety and efficacy of a drug candidate and safety, purity and potency of a proposed biologic product candidate for its intended purpose;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">preparation of and submission to the FDA of a new drug application, or NDA, or biologics license application, or BLA, as applicable, after completion of all pivotal clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">satisfactory completion of an FDA Advisory Committee review, if applicable;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">a determination by the FDA within 60&nbsp;days of its receipt of an NDA or BLA to file the application for review;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing Practice requirements, or cGMPs, and of selected clinical investigation sites to assess compliance with GCPs; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">FDA review and approval of an NDA, or licensure of a BLA, to permit commercial marketing of the product for particular indications for use in the United&nbsp;States.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Preclinical and Clinical Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to beginning the first clinical trial with
  a product candidate, we must submit an IND to the FDA.&nbsp;An IND is a request for authorization from the FDA to administer an investigational
  new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol or protocols
  for preclinical studies and clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics,
  pharmacology and harmacodynamics characteristics of the product, chemistry, manufacturing and controls information, and any available
  human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials
  may begin. The IND automatically becomes effective 30&nbsp;days after receipt by the FDA, unless the FDA, within the 30-day period, raises
  safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor
  and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may
  or may not result in FDA authorization to begin a clinical trial.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials involve the administration of
  the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include
  the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials
  are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety
  and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial
  conducted during product development and for any subsequent protocol amendments. Furthermore, an independent institutional review board
  for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent
  form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the institutional
  review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being
  exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight
  by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides
  authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and
  may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration
  of efficacy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For purposes of biopharmaceutical development,
  human clinical trials are typically conducted in three sequential phases that may overlap or be combined;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt"><I>&#9679;</I></TD>
      <TD STYLE="font-size: 10pt"><I>Phase&nbsp;1. </I>The investigational product is initially introduced into patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"><I>&nbsp;</I></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt"><I>&#9679;</I></TD>
      <TD STYLE="font-size: 10pt"><I>Phase&nbsp;2. </I>The investigational product is administered to a limited patient population to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt"><I>Phase&nbsp;3. </I>The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In some cases, the FDA may require, or companies
  may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called
  Phase&nbsp;4 studies may be made a condition to approval of the application. Concurrent with clinical trials, companies may complete additional
  animal studies and develop additional information about the characteristics of the product candidate and must finalize a process for manufacturing
  the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing
  quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and
  purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and
  tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over
  its shelf life.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">During all phases of clinical development, regulatory
  agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. The FDA
  or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that
  the research patients or patients are being exposed to an unacceptable health risk. Similarly, an institutional review board can suspend
  or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the institutional
  review board&rsquo;s requirements or if the biological product candidate has been associated with unexpected serious harm to patients.
  There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
  Sponsors of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information, which
  is publicly available at <I>www.clinicaltrials.gov</I>.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>NDA/BLA Submission and Review</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Assuming successful completion of all required
  testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical
  trials are submitted to the FDA as part of an NDA or BLA, as applicable, requesting approval to market the product for one or more indications.
  The application must include all relevant data available from pertinent preclinical studies and clinical trials, including negative or
  ambiguous results as well as positive findings, together with detailed information relating to the product&rsquo;s chemistry, manufacturing,
  controls, and proposed labeling, among other things. The submission of an application requires payment of a substantial application user
  fee to the FDA, unless a waiver or exemption applies. The FDA has sixty&nbsp;days from the applicant&rsquo;s submission to either issue
  a refusal to file letter or accept the application for filing, indicating that it is sufficiently complete to permit substantive review.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once an NDA or BLA has been accepted for filing,
  the FDA&rsquo;s goal is to review standard applications within 10&nbsp;months after it accepts the application for filing, or, if the
  application qualifies for priority review, six&nbsp;months after the FDA accepts the application for filing. In both standard and priority
  reviews, the review process is often significantly extended by FDA requests for additional information or clarification. The FDA reviews
  an NDA to determine whether a drug is safe and effective for its intended use and a BLA to determine whether a biologic is safe, pure
  and potent. FDA also reviews whether the facility in which the product is manufactured, processed, packed or held meets standards designed
  to assure and preserve the product&rsquo;s identity, safety, strength, quality, potency and purity. The FDA may convene an advisory committee
  to provide clinical insight on application review questions. Before approving an NDA or BLA, the FDA will typically inspect the facility
  or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes
  and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
  Additionally, before approving an application, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs.
  If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the
  deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested
  additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">After the FDA evaluates an application and conducts
  inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may
  issue an approval letter or a Complete Response letter. An approval letter authorizes commercial marketing of the product with specific
  prescribing information for specific indications. A Complete Response letter will describe all of the deficiencies that the FDA has identified
  in the application, except that where the FDA determines that the data supporting the application are inadequate to support approval,
  the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted product lots and/or reviewing
  proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant might take to place the application
  in condition for approval, including requests for additional information or clarification, which may include the potential requirement
  for additional clinical studies. The FDA may delay or refuse approval of an application if applicable regulatory criteria are not satisfied,
  require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If regulatory approval of a product is granted,
  such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be
  marketed. For example, the FDA may approve the application with a risk evaluation and mitigation strategy, or REMS, to ensure the benefits
  of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and
  to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician
  communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization
  tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls
  and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is
  not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase&nbsp;4 post-market
  studies and surveillance to further assess and monitor the product&rsquo;s safety and effectiveness after commercialization, and may limit
  further marketing of the product based on the results of these post-marketing studies.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Expedited Development and Review Programs</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA offers a number of expedited development
  and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing
  new products that meet certain criteria. Specifically, new products are eligible for fast track designation if they are intended to treat
  a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
  Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor
  of a fast track product has opportunities for frequent interactions with the review team during product development and, once an NDA or
  BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where
  the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor
  provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines
  that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A product intended to treat a serious or life-threatening
  disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product can receive
  breakthrough therapy designation if preliminary clinical evidence indicates that the product, alone or in combination with one or more
  other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,
  such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features,
  as well as more intensive FDA interaction and guidance beginning as early as Phase&nbsp;1 and an organizational commitment to expedite
  the development and review of the product, including involvement of senior managers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any marketing application for a drug or biologic
  submitted to the FDA for approval, including a product with a fast track designation and/or breakthrough therapy designation, may be eligible
  for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval.
  A product is eligible for priority review if it has the potential to provide a significant improvement in the treatment, diagnosis or
  prevention of a serious disease or condition. Priority review designation means the FDA&rsquo;s goal is to take action on the marketing
  application within six&nbsp;months of the 60-day filing date.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, products studied for their safety
  and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination
  that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint
  that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible
  morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability
  or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate
  and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality
  or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional
  materials, which could adversely impact the timing of the commercial launch of the product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Fast track designation, breakthrough therapy designation
  and priority review do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies
  for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide
  that the time period for FDA review or approval will not be shortened.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Orphan Drug Designation</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Orphan Drug Act, the FDA may grant orphan
  designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than
  200,000 individuals in the United&nbsp;States, or more than 200,000 individuals in the United&nbsp;States for which there is no reasonable
  expectation that the cost of developing and making available in the United&nbsp;States a drug or biologic for this type of disease or
  condition will be recovered from sales in the United&nbsp;States for that drug or biologic. Orphan drug designation must be requested
  before submitting an NDA or BLA.&nbsp;After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and
  its potential orphan use are disclosed publicly by the FDA.&nbsp;The orphan drug designation does not convey any advantage in, or shorten
  the duration of, the regulatory review or approval process.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If a product that has orphan drug designation
  subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug
  exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full NDA or BLA, to
  market the same drug or biologic for the same indication for seven&nbsp;years, except in limited circumstances, such as a showing of clinical
  superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown
  that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition
  for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the
  same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug
  designation are tax credits for certain research and a waiver of the NDA or BLA application fee.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A designated orphan drug may not receive orphan
  drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition,
  exclusive marketing rights in the United&nbsp;States may be lost if the FDA later determines that the request for designation was materially
  defective.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Post-Approval Requirements</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any products manufactured or distributed by us
  pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating
  to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion
  of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject
  to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee
  for each product identified in an approved NDA or BLA.&nbsp;Biopharmaceutical manufacturers and their subcontractors are required to register
  their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain
  state agencies for compliance with cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
  Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval
  before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting
  requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time,
  money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA may withdraw approval if compliance with
  regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of
  previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
  or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
  of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions
  under a REMS program. Other potential consequences include, among other things:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">fines, warning or untitled letters or holds on post-approval clinical studies;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">product seizure or detention, or refusal of the FDA to permit the import or export of products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">mandated modification of promotional materials and labeling and the issuance of corrective information;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt; text-align: justify">injunctions or the imposition of civil or criminal penalties.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA closely regulates the marketing, labelling,
  advertising and promotion of biopharmaceutical products. A company can make only those claims relating to safety and efficacy, purity
  and potency that are approved by the FDA and in accordance with the provisions of the approved label. However, companies may share truthful
  and not misleading information that is otherwise consistent with a product&rsquo;s FDA approved labelling. The FDA and other agencies
  actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result
  in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians
  may prescribe legally available products for uses that are not described in the product&rsquo;s labelling and that differ from those tested
  by us and approved by the FDA.&nbsp;Such off-label uses are common across medical specialties. Physicians may believe that such off-label
  uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice
  of treatments. The FDA does, however, restrict manufacturer&rsquo;s communications on the subject of off-label use of their products.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>U.S.&nbsp;Market Exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A biological product can obtain pediatric market
  exclusivity in the U.S., which, if granted, adds six&nbsp;months to existing exclusivity periods, including some regulatory exclusivity
  periods tied to patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may
  be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued &ldquo;Written Request&rdquo; for such
  a study.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Biologics Price Competition and Innovation
  Act&nbsp;of&nbsp;2009, or BPCIA, created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable
  with, an FDA-licensed reference biological product. This amendment to the PHSA attempts to minimize duplicative testing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Biosimilarity, which requires that there be no
  clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can
  be shown through analytical studies, animal studies, and a clinical trial or trials. Interchangeability requires that a product is biosimilar
  to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference
  product and, for products administered multiple times, the biologic and the reference biologic may be interchanged after one has been
  previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
  However, complexities associated with the larger, and often more complex, structure of biological products, as well as the process by
  which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA will not accept an application for a biosimilar
  or interchangeable product based on the reference biological product until four&nbsp;years after the date of first licensure of the reference
  product, and the FDA will not approve an application for a biosimilar or interchangeable product based on the reference biological product
  until 12&nbsp;years after the date of first licensure of the reference product. &ldquo;First licensure&rdquo; typically means the initial
  date the particular product at issue was licensed in the U.S.&nbsp;Date of first licensure does not include the date of licensure of (and
  a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product
  or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or
  other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication,
  route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure
  of the biological product that does not result in a change in safety, purity, or potency.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The BPCIA is complex and continues to be interpreted
  and implemented by the FDA.&nbsp;In addition, government proposals have sought to reduce the 12-year reference product exclusivity period.
  Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation.
  As a result, the ultimate implementation and impact of the BPCIA is subject to significant uncertainty.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Pediatric Study Plan and Pediatric Exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Pediatric Research Equity Act, as amended,
  or the PREA, certain NDAs and certain NDA supplements must contain data that can be used to assess the safety and efficacy of the product
  candidate for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric
  subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial
  waivers. The PREA requires that a sponsor who is planning to submit a marketing application for a product candidate that includes a new
  active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study
  Plan, or the PSP, within 60&nbsp;days of an end-of-phase 2 meeting or, if there is no such meeting, as early as practicable before the
  initiation of the phase 3 or phase 2/3 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor
  plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for
  not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement
  to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP.&nbsp;A
  sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on
  data collected from preclinical studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required
  by regulation, the PREA does not apply to a drug for an indication for which orphan designation has been granted, except that the PREA
  will apply to an original NDA for a new active ingredient that is orphan-designated if the drug is a molecularly targeted cancer product
  intended for the treatment of an adult cancer and is directed at a molecular target that the FDA determines to be substantially relevant
  to the growth or progression of a pediatric cancer.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A drug can also obtain pediatric market exclusivity
  in the United&nbsp;States. Pediatric exclusivity, if granted, adds six&nbsp;months to existing exclusivity periods and patent terms. This
  six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion
  of a pediatric study in accordance with an FDA-issued &ldquo;Written Request&rdquo; for such a study.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Patent Term Restoration and Extension</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Depending upon the timing, duration and specifics
  of the FDA approval of our product candidates, some of our U.S.&nbsp;patents may be eligible for limited patent term extension. The provisions
  of the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, permit a patent restoration term
  of up to five&nbsp;years as compensation for patent term lost during product development and the FDA regulatory review process. However,
  patent term restoration cannot extend the remaining term of a patent beyond a total of 14&nbsp;years from the product&rsquo;s approval
  date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of
  a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved
  product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The
  USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future,
  we may apply for restoration of patent term for one of our currently owned or licensed patents to add patent life beyond its current expiration
  date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many other countries also provide for patent term
  extensions or similar extensions of patent protection for biologic products. For example, in Japan, it may be possible to extend the patent
  term for up to five&nbsp;years and in Europe, it may be possible to obtain a supplementary patent certificate that would effectively extend
  patent protection for up to five&nbsp;years.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Federal and State Fraud and Abuse, Data Privacy and Security, and
  Transparency Laws and Regulations</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to FDA restrictions on marketing of
  pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry.
  These laws may impact, among other things, our current and future business operations, including our clinical research activities, and
  proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare
  providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws
  include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including,
  without limitation, those laws described below.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The U.S.&nbsp;federal Anti-Kickback Statute prohibits
  any person or entity from, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce
  or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable
  under Medicare, Medicaid or other federal healthcare programs. The term &ldquo;remuneration&rdquo; has been broadly interpreted to include
  anything of value. The U.S.&nbsp;federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
  on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions and
  regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices
  that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny
  if they do not qualify for an exception or safe harbor. Several courts have interpreted the statute&rsquo;s intent requirement to mean
  that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute
  has been violated.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A person or entity does not need to have actual
  knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert
  that a claim including items or services resulting from a violation of the U.S.&nbsp;federal Anti-Kickback Statute constitutes a false
  or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary penalties laws.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Federal civil and criminal false claims laws and
  civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower
  and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false
  claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material
  to a false or fraudulent claim to the federal government. A claim includes &ldquo;any request or demand&rdquo; for money or property presented
  to the U.S.&nbsp;government. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly
  providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies
  have been prosecuted for causing false claims to be submitted because of the companies&rsquo; marketing of products for unapproved, and
  thus non-reimbursable, uses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The federal Health Insurance Portability and Accountability
  Act&nbsp;of&nbsp;1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully
  executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,
  concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery
  of or payment for healthcare benefits, items or services. Also, many states have similar fraud and abuse statutes or regulations that
  apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we may be subject to data privacy
  and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health
  Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose specified
  requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable
  health information. Among other things, HITECH makes HIPAA&rsquo;s security standards directly applicable to &ldquo;business associates,&rdquo;
  defined as independent contractors or agents of covered entities, which include certain healthcare providers, healthcare clearinghouses
  and health plans, that create, receive, maintain or transmit individually identifiable health information in connection with providing
  a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered
  entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages
  or injunctions in federal courts to enforce HIPAA and seek attorney&rsquo;s fees and costs associated with pursuing federal civil actions.
  In addition, state laws govern the privacy and security of health information in certain circumstances, many of which are not pre-empted
  by HIPAA, differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The federal Physician Payments Sunshine Act requires
  certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the
  Children&rsquo;s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare&nbsp;&amp; Medicaid
  Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable
  manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians
  and their immediate family members.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may also be subject to state laws that require
  pharmaceutical companies to comply with the pharmaceutical industry&rsquo;s voluntary compliance guidelines and the relevant compliance
  guidance promulgated by the federal government, state laws that require drug manufacturers to report information related to payments and
  other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing, and state and local laws
  that require the registration of pharmaceutical sales representatives.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because of the breadth of these laws and the narrowness
  of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to
  challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described
  above or any other governmental regulations that apply to us, we may be subject to significant criminal, civil and administrative penalties
  including damages, fines, imprisonment, disgorgement, additional reporting requirements and oversight if we become subject to a corporate
  integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm,
  diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment
  or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
  To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which
  may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, implementation
  of corporate compliance programs, reporting of payments or transfers of value to healthcare professionals, and additional data privacy
  and security requirements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Healthcare Reform</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Coverage and Reimbursement</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The future commercial success of our product candidates,
  if approved, will depend in part on the extent to which third-party payors, such as governmental payor programs at the federal and state
  levels, including Medicare and Medicaid, private health insurers and other third-party payors, provide coverage of and establish adequate
  reimbursement levels for our product candidates. Third-party payors generally decide which products they will pay for and establish reimbursement
  levels for those products. In particular, in the United&nbsp;States, no uniform policy for coverage and reimbursement exists. Private
  health insurers and other third-party payors often provide coverage and reimbursement for products based on the level at which the government,
  through the Medicare program, provides coverage and reimbursement for such products, but also on their own methods and approval process
  apart from Medicare determinations. Therefore, coverage and reimbursement can differ significantly from payor to payor.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, the European Union,
  or EU, and other potentially significant markets for our product candidates, government authorities and third-party payors are increasingly
  attempting to limit or regulate the price of products, particularly for new and innovative products, which often has resulted in average
  selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United&nbsp;States and
  on country and regional pricing and reimbursement controls in the EU will put additional pressure on product pricing, reimbursement and
  usage. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related
  to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Third-party payors are increasingly imposing additional
  requirements and restrictions on coverage and limiting reimbursement levels for products. For example, federal and state governments reimburse
  products at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of products.
  Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved
  products for a particular indication. Similarly, because certain of our product candidates are physician-administered, separate reimbursement
  for the product itself may or may not be available. Instead, the administering physician may only be reimbursed for providing the treatment
  or procedure in which our product is used. Third-party payors are increasingly challenging the price and examining the medical necessity
  and cost-effectiveness of products, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies
  in order to demonstrate the medical necessity and cost-effectiveness of our product candidates, in addition to the costs required to obtain
  the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor&rsquo;s decision to provide
  coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-party payor reimbursement may
  not be available to enable us to realize an appropriate return on our investment in product development. Legislative proposals to reform
  healthcare or reduce costs under government insurance programs may result in lower reimbursement for our product candidates, if approved,
  or exclusion of our product candidates from coverage and reimbursement. The cost containment measures that third-party payors and providers
  are instituting and any healthcare reform could significantly reduce our revenue from the sale of any approved product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The United&nbsp;States and some foreign jurisdictions
  are considering enacting or have enacted a number of additional legislative and regulatory proposals to change the healthcare system in
  ways that could affect our ability to sell our product candidates profitably, if approved. Among policy makers and payors in the United&nbsp;States
  and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare
  costs, improving quality and expanding access. In the United&nbsp;States, the pharmaceutical industry has been a particular focus of these
  efforts, which include major legislative initiatives to reduce the cost of care through changes in the healthcare system, including limits
  on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded healthcare
  programs, and increased governmental control of drug pricing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There have been several U.S.&nbsp;government initiatives
  over the past few&nbsp;years to fund and incentivize certain comparative effectiveness research, including creation of the Patient-Centered
  Outcomes Research Institute under the ACA.&nbsp;It is also possible that comparative effectiveness research demonstrating benefits in
  a competitor&rsquo;s product could adversely affect the sales of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ACA became law in March&nbsp;2010 and substantially
  changed the way healthcare is financed by third-party payors, and significantly impacts the U.S.&nbsp;pharmaceutical industry. Among other
  measures that may have an impact on our business, the ACA established an annual, nondeductible fee on any entity that manufactures or
  imports specified branded prescription drugs and biologic agents; a new Medicare Part&nbsp;D coverage gap discount program; and a new
  formula that increased the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Additionally, the ACA extended manufacturers&rsquo;
  Medicaid rebate liability, expands eligibility criteria for Medicaid programs, and expanded entities eligible for discounts under the
  Public Health Service Act. At this time, we are unsure of the full impact that the ACA will have on our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Since its enactment, there have been judicial
  and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace
  certain aspects of the ACA, and we expect such challenges and amendments to continue. Since January&nbsp;2017, President Trump has signed
  two Executive Orders and other directives designed to delay the implementation of certain ACA provisions or otherwise circumvent requirements
  for health insurance mandated by the ACA.&nbsp;Concurrently, Congress has considered legislation that would repeal or repeal and replace
  all or part of the ACA.&nbsp;While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of
  certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act&nbsp;of&nbsp;2017, or Tax Act, includes a provision that
  repealed, effective January&nbsp;1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail
  to maintain qualifying health coverage for all or part of a year that is commonly referred to as the &ldquo;individual mandate.&rdquo;
  On January&nbsp;22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation
  of certain ACA-mandated fees, including the so-called &ldquo;Cadillac&rdquo; tax on certain high cost employer-sponsored insurance plans,
  the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on nonexempt medical
  devices. The Bipartisan Budget Act&nbsp;of&nbsp;2018, or the BBA, among other things, amended the ACA, effective January&nbsp;1, 2019,
  to increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part&nbsp;D
  and to close the coverage gap in most Medicare drug plans, commonly referred to as the &ldquo;donut hole.&rdquo; In July&nbsp;2018, CMS
  published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance
  issuers under the ACA adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses
  to determine this risk adjustment. In December&nbsp;2018, a U.S.&nbsp;District Court Judge in the Northern District of Texas, or Texas
  District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was
  repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well. While the Texas District Court Judge, as well
  as the Trump administration and CMS, have stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent
  appeals, and other efforts to repeal and replace the ACA will impact the ACA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, other legislative changes have been
  proposed and adopted since the ACA was enacted. In August&nbsp;2011, the President signed into law the Budget Control Act&nbsp;of&nbsp;2011,
  as amended, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began
  in 2013 and, following passage of subsequent legislation, including the BBA, will continue through 2027 unless additional Congressional
  action is taken. In January&nbsp;2013, the American Taxpayer Relief Act&nbsp;of&nbsp;2012 was enacted which, among other things, reduced
  Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments
  to providers from three to five&nbsp;years.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Further, there has been increasing legislative
  and enforcement interest in the United&nbsp;States with respect to drug pricing practices. Specifically, there have been several recent
  U.S.&nbsp;Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency
  to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement
  methodologies for drugs. At the federal level, the Trump administration&rsquo;s budget proposal for fiscal year 2019 contains further
  drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example,
  measures to permit Medicare Part&nbsp;D plans to negotiate the price of certain drugs under Medicare Part&nbsp;B, to allow some states
  to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Additionally, the Trump
  administration released a &ldquo;Blueprint&rdquo; to lower drug prices and reduce out of pocket costs of drugs that contains additional
  proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers
  to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. The U.S.&nbsp;Department
  of Health and Human Services, or HHS, has already started the process of soliciting feedback on some of these measures and is implementing
  others under its existing authority. For example, in September&nbsp;2018, CMS announced that it will allow Medicare Advantage plans the
  option to use step therapy for Part&nbsp;B drugs beginning January&nbsp;1, 2019. On January&nbsp;31, 2019, the HHS Office of Inspector
  General proposed modifications to U.S.&nbsp;federal Anti-Kickback Statute safe harbors which, among other things, may affect rebates paid
  by manufacturers to Medicare Part&nbsp;D plans, the purpose of which is to further reduce the cost of drug products to consumers. In addition,
  CMS issued a final rule, effective on July&nbsp;9, 2019, that requires direct-to-consumer television advertisements of prescription drugs
  and biological products, for which payment is available through or under Medicare or Medicaid, to include in the advertisement the Wholesale
  Acquisition Cost, or list price, of that drug or biological product if it is equal to or greater than $35 for a monthly supply or usual
  course of treatment. Prescription drugs and biological products that are in violation of these requirements will be included on a public
  list. Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures
  to control drug costs. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control
  pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain
  product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other
  countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures
  to determine which drugs and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by
  third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices. These measures
  could reduce future demand for our products or put pressure on our pricing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, in May&nbsp;2018, the Trickett Wendler,
  Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act&nbsp;of&nbsp;2017, or the Right to Try Act, was signed into law.
  The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that
  have completed a Phase&nbsp;1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible
  patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program.
  There is no obligation for a drug manufacturer to make its drug products available to eligible patients as a result of the Right to Try
  Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Foreign Regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to market any product outside of the
  United&nbsp;States, we would need to comply with numerous and varying regulatory requirements of other countries regarding safety and
  efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product
  candidates. For example, in the EU, we must obtain authorization of a clinical trial application, or CTA, in each member state in which
  we intend to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals
  by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those
  countries. The approval process varies from country to country and can involve additional product testing and additional administrative
  review periods. The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA
  approval. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory
  approval in one country may negatively impact the regulatory process in others.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Further, some countries outside of the United&nbsp;States,
  including the EU member states, Switzerland and the United Kingdom, have also adopted data protection laws and regulations, which impose
  significant compliance obligations. In the EU, the collection and use of personal health data is governed by the provisions of the General
  Data Protection Regulation, or GDPR.&nbsp;The GDPR became effective on May&nbsp;25, 2018, repealing its predecessor directive and increasing
  responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects. The GDPR, together
  with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions
  on the ability to process personal data, including health data from clinical trials and adverse event reporting. In particular, these
  obligations and restrictions concern potentially burdensome documentation requirements, granting certain rights to individuals to control
  how we collect, use, disclose, retain and process information about them, the information provided to the individuals, the transfer of
  personal data out of the EU, security breach notifications, and security and confidentiality of the personal data. The processing of sensitive
  personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest
  among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to &euro;20&nbsp;million
  or 4% of the annual global revenue of the noncompliant company, whichever is greater. Data protection authorities from the different EU
  member states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of
  processing personal data in the EU.&nbsp;Guidance on implementation and compliance practices are often updated or otherwise revised.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>European Union</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>European Union Coverage Reimbursement and Pricing</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the European Union, pricing and reimbursement
  schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
  has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug
  candidate to currently available therapies, or so called health technology assessments, in order to obtain reimbursement or pricing approval.
  For example, the European Union provides options for its member states to restrict the range of drug products for which their national
  health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states
  may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the
  company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>EU Drug regulation</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to market any product outside of the
  United&nbsp;States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
  quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
  of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable
  foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions
  such as in China and Japan. Although many of the issues discussed above with respect to the United&nbsp;States apply similarly in the
  context of the EU, the approval process varies between countries and jurisdictions and can involve additional product testing and additional
  administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer
  than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another,
  but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in
  others. Failure to comply with applicable foreign regulatory requirements, may be subject to, among other things, fines, suspension or
  withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Non-clinical studies and clinical trials</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similarly to the United&nbsp;States, the various
  phases of non-clinical and clinical research in the EU are subject to significant regulatory controls.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Non-clinical studies are performed to demonstrate
  the health or environmental safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with
  the principles of good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC.&nbsp;In particular, non-clinical studies, both
  in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which
  define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These
  GLP standards reflect the Organization for Economic Co-operation and Development requirements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials of medicinal products in the EU
  must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on
  good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the
  Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical
  trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint
  an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU
  member states, the sponsor is liable to provide &lsquo;no fault&rsquo; compensation to any study subject injured in the clinical trial.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Certain countries outside of the United&nbsp;States,
  including the EU, have a similar process that requires the submission of a clinical study application (CTA) much like the IND prior to
  the commencement of human clinical studies. A CTA must be submitted to each country&rsquo;s national health authority and an independent
  ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved by the national health authority and the ethics
  committee has granted a positive opinion in relation to the conduct of the trial in the relevant member state(s), in accordance with a
  country&rsquo;s requirements, clinical study development may proceed.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CTA must include, among other things, a copy
  of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
  medicinal product under investigation. Currently, CTAs must be submitted to the competent authority in each EU member state in which the
  trial will be conducted. Under the new Regulation on Clinical Trials, which is currently expected to become applicable by early 2022,
  there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other
  national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with
  the CTA must be notified to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials
  must be manufactured in accordance with good manufacturing practice (GMP). Other national and EU-wide regulatory requirements also apply.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Marketing Authorizations</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To market a medicinal product in the EU and in
  many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates
  can only be commercialized after obtaining a Marketing Authorization (MA). To obtain regulatory approval of an investigational medicinal
  product under EU regulatory systems, we must submit a marketing authorization application (MAA.) The process for doing this depends, among
  other things, on the nature of the medicinal product. There are two types of Mas:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">the &ldquo;Union MA&rdquo;, which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and which is valid throughout the entire territory of the EU.&nbsp;The Centralized Procedure is mandatory for certain types of products, such as (i)&nbsp;medicinal products derived from biotechnology medicinal products, (ii)&nbsp;designated orphan medicinal products, (iii)&nbsp;advanced therapy products (such as gene therapy, somatic cell therapy or tissue-engineered medicines), and (iv)&nbsp;medicinal products containing a new active substance indicated for the treatment certain diseases, such as HIV/AIDS, cancer, neurodegenerative diseases, diabetes, other auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or that the granting of authorization would be in the interest of public health in the EU; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px; font-size: 10pt">&#9679;</TD>
      <TD STYLE="font-size: 10pt">&ldquo;National Mas&rdquo;, which are issued by the competent authorities of the EU member states and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in an EU member state, this National MA can be recognized in another member state through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the Reference member state.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the above-described procedures, in order
  to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product
  on the basis of scientific criteria concerning its quality, safety and efficacy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Centralized Procedure, the maximum timeframe
  for the evaluation of a MAA by the EMA is 210&nbsp;days. Where there is a major public health interest and an unmet medical need for a
  product, the CHMP may perform an accelerated review of a MA in no more than 150&nbsp;days (not including clock stops). Innovative products
  that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development
  and review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the US PRIME
  is a voluntary scheme aimed at enhancing the EMA&rsquo;s support for the development of medicines that target unmet medical needs. It
  is based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development
  plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from PRIME designation can expect
  to be eligible for accelerated assessment but this is not guaranteed. The benefits of a PRIME designation include the appointment of a
  CHMP rapporteur before submission of a MAA, early dialogue and scientific advice at key development milestones, and the potential to qualify
  products for accelerated review earlier in the application process.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Mas have an initial duration of five&nbsp;years.
  After these five&nbsp;years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit
  balance, unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Data and marketing exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The EU also provides opportunities for market
  exclusivity. Upon receiving MA, new chemical entity, or reference product candidates, generally receive eight&nbsp;years of data exclusivity
  and an additional two&nbsp;years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants
  from relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic
  or biosimilar MA in the EU during a period of eight&nbsp;years from the date on which the reference product was first authorized in the
  EU.&nbsp;The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU
  until 10&nbsp;years have elapsed from the initial authorization of the reference product in the EU.&nbsp;The overall 10-year market exclusivity
  period can be extended to a maximum of eleven&nbsp;years if, during the first eight&nbsp;years of those 10&nbsp;years, the MA holder obtains
  an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are
  held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will
  be considered by the EU&rsquo;s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Pediatric Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the EU, MAAs for new medicinal products candidates
  have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (PIP) agreed
  with the EMA&rsquo;s Pediatric Committee (PDCO). The PIP sets out the timing and measures proposed to generate data to support a pediatric
  indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures
  of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to
  provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely
  to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations,
  or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA
  is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible
  for six&nbsp;months&rsquo; supplementary protection certificate extension (if any is in effect at the time of authorization).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
  
  <!-- Field: Page; Sequence: 55; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Post-Approval Requirements</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similar to the United&nbsp;States, both MA holders
  and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the
  competent regulatory authorities of the member states. The holder of a MA must establish and maintain a pharmacovigilance system and appoint
  an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
  reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">All new MAA must include a risk management plan
  (RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks
  associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA.&nbsp;Such risk-minimization
  measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct
  of additional clinical trials or post-authorization safety studies.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The advertising and promotion of medicinal products
  is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
  and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
  of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
  is also prohibited in the EU.&nbsp;Although general requirements for advertising and promotion of medicinal products are established under
  EU directives, the details are governed by regulations in each member state and can differ from one country to another.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The aforementioned EU rules are generally applicable
  in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For other countries outside of the EU, such as
  countries in Latin America or Asia (e.g. China and Japan), the requirements governing the conduct of clinical studies, product licensing,
  pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP
  and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail
  to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of
  regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Privacy and data protection laws</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are also subject to laws and regulations in
  non-US countries covering data privacy and the protection of health-related and other personal information. For instance, EU member states
  and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. Laws and regulations
  in these jurisdictions apply broadly to the collection, use, storage, disclosure, processing and security of personal information that
  identifies or may be used to identify an individual, such as names, contact information, and sensitive personal data such as health data.
  These laws and regulations are subject to frequent revisions and differing interpretations,</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of May&nbsp;2018, the General Data Protection
  Regulation (GDPR) replaced the Data Protection Directive with respect to the processing of personal data in the European Union. The GDPR
  imposes many requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent
  from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime,
  shortened timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining
  to health data and pseudonymised (i.e., key-coded) data and additional obligations when we contract third-party processors in connection
  with the processing of the personal data. The GDPR allows EU member states to make additional laws and regulations further limiting the
  processing of genetic, biometric or health data. Failure to comply with the requirements of GDPR and the applicable national data protection
  laws of the EU member states may result in fines of up to &euro;20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
  financial year, whichever is higher, and other administrative penalties.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Japan</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Japanese drug regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Non-clinical studies and clinical trials</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Being a member of the International Conference
  on Harmonization (ICH), Japan has pharmaceutical regulations fundamentally similar to those of the United&nbsp;States or EU.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Non-clinical studies are performed to demonstrate
  the health safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with the principles of
  Japanese good laboratory practice (GLP) which reflect the Organization for Economic Co-operation and Development requirements. Currently,
  Japan and EU have a mutual recognition agreement for GLP, and data generated compliant with EU requirements will be accepted by the Japanese
  authorities. There is no similar agreement with the United&nbsp;States.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical trials of medicinal products in Japan
  must be conducted in accordance with Japanese regulations based on ICH guidelines governing good clinical practices (GCP). They focus
  on ethics of the clinical trial and protection of the privacy of the trial subjects. If the sponsor of the clinical trial is not established
  within Japan, it must appoint an entity within the country to act as its caretaker who should be authorized to act on the sponsor&rsquo;s
  behalf. The sponsor must take out a clinical trial insurance policy, and, according to the industry agreement, should put in place a common
  compensation policy for the injuries from the trial.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to the commencement of human clinical studies,
  the sponsor must complete evaluation of the safety of the investigative product, and submit a clinical trial notification and the protocol
  to the authorities in advance, upon agreement of the IRB of the participating institutions. When the authorities do not comment on the
  notification, the sponsor may proceed with the clinical trial.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any substantial changes to the trial protocol
  or other information submitted must be cleared by the IRB and notified to the authorities. Medicines used in clinical trials must be manufactured
  in accordance with good manufacturing practice (GMP).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Product approval</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To market a medicinal product in Japan, we must
  obtain regulatory approval. To obtain regulatory approval of an investigational medicinal product, we must submit a new drug application.
  The process for doing this depends, among other things, on the nature of the medicinal product and there are currently a few different
  pathways for approval. If the product is designed for treating certain &ldquo;difficult diseases&rdquo; or those whose patient size is
  limited, we may be able to obtain designation as an orphan drug product if it demonstrates unique therapeutic value. Approval application
  for such designated orphan products will be processed on an expedited basis and the authorities&rsquo; requirement for clinical data will
  be much limited. Separately, the latest amendment to the law introduced separate pathways for (i)&nbsp;truly innovative products with
  a unique mode of action and (ii)&nbsp;those which will satisfy unmet medical needs. These products will also be processed on an expedited
  basis.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The evaluation of applications will be based on
  an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
  Once the review organization complete its review task, the matter will be considered by the advisory committee of experts, and the government
  will grant approval upon positive recommendation from the committee.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The volume and quality of the clinical data will
  be the key determinant of the approval decision. Clinical trial data generated overseas will be accepted as part of the data package consistent
  with the ICH recommendation. Typically, a limited dose response clinical trial for Japanese subjects is required to ensure that data are
  extrapolatable for the Japanese population. In a more recent development, the authorities encourage manufacturers to organize an international
  joint clinical trial with some Japanese participation under a joint protocol, to expedite the clinical trial process. Regulatory approval
  does not expire.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
  <!-- Field: Page; Sequence: 57; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Licensing requirement</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Separate from the approval requirement, it is
  also mandatory to possess a distribution license of an appropriate class for the manufacturer to commercially distribute the product in
  Japan. Non-Japanese companies who possess only the product approval may designate an appropriate license holder in Japan to commercially
  distribute the product, rather than distributing it on its own. The license is valid for 5&nbsp;years.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Intellectual Property</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Exclusive License Agreement with Children&rsquo;s Hospital Medical
  Center, d/b/a Cincinnati Children&rsquo;s Hospital Medical Center</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On June&nbsp;1, 2021 (the &ldquo;Effective Date&rdquo;),
  the Company entered into a license agreement with Children&rsquo;s Hospital Medical Center, d/b/a Cincinnati Children&rsquo;s Hospital
  Medical Center (&ldquo;CHMC&rdquo;) to develop and commercialize certain CHMC patents and related technology directed at a virus-like
  particle (VLP) vaccine platform that utilizes nanoparticle delivery technology, which may have potential broad application to develop
  vaccines for multiple infectious diseases (&ldquo;the CHMC Agreement&rdquo;). The license is exclusive, worldwide, and is for all uses
  (other than the &ldquo;Excluded Field&rdquo; of immunization against, and prevention, control, or reduction in severity of gastroenteritis
  caused by Rotavirus and Norovirus in China and Hong&nbsp;Kong). The license is sublicensable with prior CHMC written approval consistent
  with the terms of the CHMC Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement includes the below patents,
  which we refer to as the &ldquo;Licensed Patents&rdquo;, and any divisionals, continuations and continuations-in-part thereto (solely
  to the extent that the claims in the continuations-in-part are directed to the subject matter specifically claimed in the Licensed Patents,
  and they have the same priority date as the Licensed Patents, but do not include any different or additional claims), and any patents
  resulting therefrom:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; width: 18%"><B>U.S.&nbsp;Patent<BR>
  Application No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center"><B>U.S.<BR>
  Patent<BR>
   No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 21%; text-align: center"><B>Granted Claim Type</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 10%; text-align: center"><B>U.S.<BR>
  Expiration</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 37%; text-align: center"><B>Foreign Counterparts</B></TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>12/797,396</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">8,486,421</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Compositions of the vaccine/vaccine platform</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">1/13/2031</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>CN107043408B EP2440582B1 JP5894528B2</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>13/924,906</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">9,096,644</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Method of treatment</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">9/20/2030</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>CN107043408B EP2440582B1 JP5894528B2</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>13/803,057</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">9,562,077</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Compositions of the vaccine platform</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">11/8/2033</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>none</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>16/489,095</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">pending</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>pending**</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">[3/15/2038]*</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Pending applications in Canada, China, EU and Japan</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>63/149,742 (filed 2/16/2021)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">pending</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>pending**</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">[February&nbsp;2042]<SUP>#</SUP></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>TBD</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>63/162,369 (filed 3/17/2021)</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">pending</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>pending**</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">[March&nbsp;2042]<SUP>#</SUP></TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>TBD</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">*</TD>
      <TD>Projected expiration if patent issues: 20&nbsp;years from earliest non-provisional application filing date.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">#</TD>
      <TD>Non-provisional application not yet filed. Expiration projected 21&nbsp;years from provisional application filing date. Dependent on timely conversion to non-provisional application and issuance of patent.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">**</TD>
      <TD>This is a pending application. Claim type will be determined after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions of the vaccine and vaccine platform.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 58; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement also grants the Company a non-exclusive
  limited license to use and copy internally any technical information in existence and known before the Effective Date by CHMC solely as
  necessary for the use and practice of the Licensed Patents (the &ldquo;Technology&rdquo;).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The term of the CHMC Agreement begins on the Effective
  Date and extends on a jurisdiction by jurisdiction and product by product basis until the later of: (i)&nbsp;the last to expire Licensed
  Patent; (ii)&nbsp;ten (10)&nbsp;years after the first commercial sale; or, (iii)&nbsp;entrance onto the market of a biosimilar or interchangeable
  product. CHMC has reserved the right to practice, have practiced, and transfer the Licensed Patents and Technology for research and development
  purposes, including education, research, teaching, publication and public service, but not to use or practice the Licensed Patents or
  Technology in Field of Use for any commercial or profit purpose.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Licensed Patents granted to the Company under
  the CHMC Agreement are also subject to any rights of the United&nbsp;States federal, state and/or local Government(s), as well as nonprofit
  entities, if certain patents or technologies were created in the course of Government-funded or non-profit entity-funded research. The
  CHMC Agreement also contains compulsory licensing provisions under which CHMC must notify the Company in writing whenever CHMC may become
  aware of third parties that are interested in obtaining rights to the Licensed Patents or Technology for purposes that are beyond the
  scope of the Company&rsquo;s development and commercialization plan. The Company may elect to pursue the new purposes itself (and negotiate
  commercially reasonable development targets), or enter into sublicense negotiations with the interested third party. However, if the Company
  fails to meet its development targets for the new purposes or fails to enter into a sublicense agreement with the interested third party
  within nine (9)&nbsp;months of the notice from CHMC, then the new purpose will be excluded from the license grant and CHMC will be free
  to pursue licensing of the Licensed Patents or Technology within the Excluded Field to an interested third party.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any patented modification, alteration or improvement
  of any invention claimed in a Licensed Patents or Technology which is conceived or reduced to practice solely by the Company (&ldquo;Company
  Improvement&rdquo;) is owned by the Company; however, for any such Company Improvement, the Company will automatically grant to CHMC a
  worldwide, perpetual, sublicensable, nonexclusive, paid-up, royalty-free license to use any Company Improvements solely for clinical or
  non-clinical, non-commercial research, testing, educational and patient care purposes. The CHMC Agreement also provides the Company with
  an option to license any CHMC or jointly patented modification, alteration or improvement of any invention claimed in a Licensed Patent
  (&ldquo;CHMC Improvement&rdquo; and &ldquo;Joint Improvement, respectively&rdquo;), with option fee for each Improvement that the Company
  elects to include in the license grant of the CHMC Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay CHMC an aggregate
  of up to $59.75&nbsp;million upon the achievement of specified development milestones, of approximately $0.5&nbsp;million, regulatory
  milestones, of approximately $1.25&nbsp;million and commercial milestones, of approximately $58&nbsp;million (excluding any royalty arrangements).
  In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the Company is obligated
  to pay CHMC a percentage of all non-royalty sublicensing revenue. Specifically, the Company must pay twenty-five percent (25%) for revenue
  received from the sublicensee prior to first net sale of a licensed product, fifteen percent (15%) for revenue received after first net
  sale of a licensed product or five percent after the first sale of a second licensed product. No annual maintenance fee is required.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to the CHMC Agreement, the Company paid
  to CHMC a one-time $25,000 initial license fee; thereafter, the Company is required to pay $100,000 deferred license fee upon the earlier
  of the Company&rsquo;s first to occur convertible debt or equity raise after the Effective Date. On the one year anniversary of the Effective
  Date, the Company will be required to pay to CHMC an additional deferred $100,000 license fee.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the CHMC Agreement, the Company is obligated
  to use commercially reasonable efforts to bring licensed products to market through diligent research and development, testing, manufacturing
  and commercialization and to use best efforts to make all necessary regulatory filings and obtain all necessary regulatory approvals,
  and achieve milestones relating to development and sales, and report to CHMC on progress. The Company will also be obligated to pay the
  agreed upon development milestone payments to CHMC.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 59; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Development milestones include: (i)&nbsp;IND filings
  of each Licensed Product; (ii)&nbsp;BLA or equivalent allowed for Licensed Product in U.S.&nbsp;or E.U.; (iii)&nbsp;first commercial sale
  of licensed product in the U.S.; (iv)&nbsp;first commercial sale of licensed product in the E.U.; (v)&nbsp;first commercial sale of licensed
  product in Japan; (vi)&nbsp;first commercial sale in Rest of World (ROW); (vii)&nbsp;conclusion of the first calendar year. Pursuant to
  the terms of the CHMC Agreement, if the Company fails to achieve milestones or make milestone payments on certain milestones, and cannot
  mutually agree with CHMC on an amendment to the milestones, then CHMC will have the option of converting any and all of such exclusive
  licenses to nonexclusive licenses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the fees discussed above, beginning
  on the first Net Sale, the Company will pay CHMC running royalties on a quarterly basis as a percentage of Net Sales (as defined in the
  CHMC Agreement) of the Company, its affiliates and any subsidiaries. Similarly, in the event the Company enters into a sublicense agreement,
  the Company shall pay CHMC a percentage of all non-royalty sublicensing revenues received from the sublicensee. There is a 5% royalty
  rate for products and processes for P-Particle VLP Bivalent vaccine for norovirus and rotavirus; a 4% royalty rate for products and processes
  for Universal Flu Vaccine(s); and a 2% royalty rate for all other products or processes for other indications. To date, no payments have
  been made related to the milestones or royalties. Before any Valid Claims (as defined in the CHMC Agreement) exist, the running royalty
  rates are reduced by fifty percent (50%).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement also contains an anti-stacking
  provision pursuant to which in the event the Company is legally required to pay royalties to one or more third parties whose patent rights
  dominate the Licensed Patents, and would therefore be infringed by exercise of the license rights granted in the CHMC Agreement, the Company
  may reduce running royalty payments by fifty percent (50%). In the event the Company grants sublicenses, the Company is obligated to pay
  CHMC as follows: (i)&nbsp;specified percentage of revenue received prior to first Net Sale of first Licensed Product; (ii)&nbsp;specified
  percentage for revenue received after first Net Sales of first Licensed Product but before first Net Sales of second Licensed Product;
  or (iii)&nbsp;specified percentage for revenues received after first Net Sales of second Licensed Product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC reserved the first and sole right, using
  in-house or outside legal counsel selected by CHMC, to prepare, file, prosecute, maintain and extend patents and patent applications,
  and the Company agreed to reimburse CHMC for its legal and administrative costs incurred in the course of doing such. The Company also
  agreed to reimburse CHMC for incurred legal fees of approximately $177,100 as of the Effective Date. CHMC will provide the Company a reasonable
  opportunity to comment during prosecution and will consider the Company&rsquo;s comments, but CHMC retained control over all final decisions.
  If CHMC elects to not be responsible for the prosecution or maintenance of any such patents, the Company will receive a sixty (60)&nbsp;days&rsquo;
  written notice upon which the Company may elect, at the Company&rsquo;s expense, to assume the responsibilities and obligations to prosecute
  and maintain the patents (among other things); thereafter, the Company will use reasonable efforts to give CHMC an opportunity to comment,
  but the final decision with respect to such matter will remain with the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The CHMC Agreement contains no CHMC representations
  or warranties. The CHMC Agreement also requires the Company to indemnify CHMC and other related parties against all claims, suit, actions,
  demands, judgments, or investigations arising out of any product the Company produces under the CHMC Agreement, as set forth in the CHMC
  Agreement, and requires the Company, beginning with the earlier of the first clinical trial or commercial sale or other commercialization
  to obtain liability insurance.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">CHMC will have the first and sole right but not
  the obligation, at its own expense, to initiate an infringement suit or other appropriate actions against third party infringers and receives
  all therefrom. For joint suits initiated against third party infringers and receives damages or profits recovered therefrom. In the event
  CHMC does not, within six (6)&nbsp;months after becoming aware of infringement, secure cessation of the infringement, the Company will
  have the right to initiate suit at its own expense. Any damages or profits that the Company recovers will be treated as Net Sales subject
  to royalties after the Company has been compensated for its costs in handling such action. In the event of a joint infringement suit,
  the Company and CHMC will agree in writing who will control the action and how cost and recoveries will be shared.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
  <!-- Field: Page; Sequence: 60; Value: 1 -->
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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: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company may terminate the CHMC Agreement for
  convenience, at any time prior to first commercial sale of a product or process by providing one hundred and eighty (180)&nbsp;days&rsquo;
  written notice to CHMC.&nbsp;It may also terminate for a CHMC uncured material breach. CHMC may terminate the CHMC Agreement for an uncured
  Company material breach or insolvency or bankruptcy. In the event the Company&rsquo;s material breach is for failure to meet any of the
  milestone payments, the Company is entitled to a nonexclusive license to continue developing indications that have already entered development
  at any stage or in which the Company has invested in developing. CHMC may also terminate the CHMC Agreement to the fullest extent permitted
  by law in the countries of the worldwide territory, in the event the Company or its affiliates challenge or induce others set up challenges
  to the validity or enforceability of any of the Licensed Patents and the Company will be obligated reimburse CHMC for its costs, including
  reasonable attorneys&rsquo; fees.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Option Agreement between Oxford University Innovation Limited
  and Blue Water Vaccines Inc.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On December&nbsp;18, 2018, the Company entered
  into an option agreement with Oxford University Innovation Limited (&ldquo;OUI&rdquo;), pursuant to which the Company paid an option fee
  of between $25,000, to OUI in exchange for a period of exclusivity, in advance of a fundraising of fifteen million dollars ($15,000,000).
  Under the option agreement, the Company has the right to exercise the option for the grant of the right to the Company to an exclusive,
  worldwide license to PCT Patent Application number PCT/GB/2017/052510, any patents granted in response to that application, any corresponding
  foreign patents and applications deriving priority from that application, and any addition, continuation, continuation-in-part, division,
  reissue, renewal or extension based thereon, and related know-how and confidential information (the &ldquo;Technology&rdquo;).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Exercise of the option by the Company was conditional
  upon the Company submitting a business plan for the subsequent two&nbsp;years, including a development plan for the technology and a financial
  projection, demonstrating the Company&rsquo;s ability to develop the Technology and evidence of the Company&rsquo;s solvency and receipt
  of fifteen million dollars ($15,000,000) in funds for the development of the Technology. The Company has agreed that, as a condition precedent
  to the license becoming effective, it must provide funding for three&nbsp;years of salary for Dr.&nbsp;Craig Thompson in Oxford&rsquo;s
  Department of Zoology of four hundred and twenty thousand pounds (&pound;420,000). No additional funds are required to fulfill the three-year
  salary commitment, at this time, and none are anticipated prior to the completion of the three year term.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>License Agreement between Oxford University Innovation Limited
  and Blue Water Vaccines Inc.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On July&nbsp;16, 2019, the Company entered into
  an exclusive, worldwide agreement (&ldquo;OUI Agreement&rdquo;) with Oxford University Innovation Limited (&ldquo;OUI&rdquo;), pursuant
  to which the Company obtained an exclusive worldwide license for all fields to PCT Patent Application number PCT/GB/2017/052510, entitled
  &ldquo;Immunogenic Composition,&rdquo; any patents granted in response to that application, any corresponding foreign patents and applications
  deriving priority from that application, and any addition, continuation, continuation-in-part, division, reissue, renewal or extension
  based thereon, and a nonexclusive license to related know-how and confidential information, as set forth in the below chart (the &ldquo;Licensed
  Technology&rdquo;):</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt"><B>U.S.&nbsp;Patent<BR>
  Application&nbsp;No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; text-align: center"><B>U.S.&nbsp;Patent No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 20%; border-bottom: black 1.5pt solid; text-align: center"><B>Granted Claim Type</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt; text-align: center"><B>U.S.&nbsp;Expiration</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 31%; border-bottom: black 1.5pt solid; text-align: center"><B>Foreign Counterparts</B></TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>16/326,749</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">11,123,422</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Compositions and method of treatment</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">8/25/2037</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>Pending applications in Australia, Canada, China, EU and Japan</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD>17/458,712</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">pending</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>pending**</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD STYLE="text-align: center">[8/25/2037]*</TD>
      <TD STYLE="white-space: nowrap">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">*</TD>
      <TD>Projected expiration if patent issues: 20&nbsp;years from earliest non-provisional application filing date.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">**</TD>
      <TD>This is a pending application. Claim type will be determined after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions of the compositions and method of treatment.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The OUI Agreement has a term concluding ten&nbsp;years
  following the last to expire of all licensed patents and patent applications as defined under the terms of the OUI Agreement. The license
  was conditional upon the Company entering into a separate agreement with Oxford University to provide funding for three&nbsp;years&rsquo;
  salary for Dr.&nbsp;Craig Thompson in the University&rsquo;s Department of Zoology, which amounted to four hundred and twenty thousand
  pounds (&pound;420,000), which was paid by the Company in January&nbsp;2020. No additional funds are required to fulfill the three-year
  salary commitment, at this time, and none are anticipated prior to the completion of the three year term.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 61; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Improvements to the Licensed Technology as defined
  in the OUI Agreement belong to OUI and are included in the Licensed Technology. All Company Improvements of belong to the Company. The
  Company granted to OUI, and OUI subsequently granted to Oxford University, a non-transferable, irrevocable, perpetual, royalty-free license
  to use and publish the Licensed Technology and the Company&rsquo;s Improvements upon the Licensed Technology for non-commercial use. If
  a Licensed Product is covered by the Medicines Access Policy of Oxford University to promote, the Company shall adhere to the requirements
  of the Medicines Access Policy.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay OUI milestone payments
  of up to an aggregate of $51&nbsp;million upon the achievement of specified development milestones, of approximately $2.25&nbsp;million,
  regulatory milestones, of approximately $9.5&nbsp;million and commercial milestones, of approximately $39.5&nbsp;million (excluding any
  royalty arrangements). An annual maintenance fee, or minimum sum, $10,000 to $20,000 will be required beginning in 2023 through launch,
  increasing to $250,000, which would be the highest &ldquo;minimum sum&rdquo; of royalties in any year prior until expiration or revocation
  of the last valid claim covering a licensed product, in which case the annual maintenance fee will no longer be required and the &ldquo;step
  down&rdquo; royalty rate will apply.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company did not pay a signing fee to OUI and
  is obligated to pay a 6% royalty on all net sales of licensed products, as defined in the OUI Agreement, as well as royalties between
  25% on any sums received by the Company from any sublicensee (including all up-front, milestone and other one-off payments received by
  the Company from any sub-licenses or other contracts granted by the Company with respect to the licensed technology). After the expiration
  or revocation of the last Valid Claim (as defined in the OUI Agreement) covering a Licensed Product, a &ldquo;step down&rdquo; royalty
  rate shall apply to such Licensed Technology and no minimum sum will be payable by the Company. If the Company has to pay royalties to
  a third party to use a proprietary manufacturing process proprietary adjuvants in order to make or have made a Licensed Product, the Company
  will be able to deduct from all royalty payments, up to a maximum amount of twenty-five percent (25%) of the royalties due to OUI.&nbsp;The
  OUI Agreement entitles the Company to supply a commercially reasonable quantity (not exceeding 5% of units sold in any quarter) of licensed
  products for promotional sampling.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the event that royalties paid to OUI do not
  amount to the &ldquo;minimum sum&rdquo;, as discussed above, under the OUI Agreement for a particular year, the Company is obligated to
  make up the difference between the royalties actually paid and such minimum sum. The minimum sums vary over time, and reduces to $0 once
  the &ldquo;step down&rdquo; applies. The minimum sums and milestone fees are indexed to the RPI (Retail Prices index for all items which
  is published in the United Kingdom by the Office for National Statistics, or any replacement of it) and will be increased or decreased
  as appropriate as set forth in the OUI Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is obligated to use its best efforts
  to develop and market Licensed Products in accordance with its development plan report to OUI on progress and achieve the following milestones
  and must pay OUI nonrefundable milestone fees as follows when it achieves them: initiation of first Phase&nbsp;I study; initiation of
  first Phase&nbsp;II study; initiation of first Phase&nbsp;III/pivotal registration studies; first submission of application for regulatory
  approval (BLA/NDA); marketing authorization in the United&nbsp;States; marketing authorization in any EU country; marketing authorization
  in Japan; first marketing authorization in any other country; first commercial sale in Japan; first commercial sale in any ROW country;
  first year that annual sales equal or exceed certain thresholds.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is obligated to pay, and has paid,
  &pound;11,323 to OUI for any past patent expenses that were incurred prior to the execution of the OUI Agreement. Upon consultation with
  the Company and at the Company&rsquo;s expense, OUI shall prosecute, use all reasonable endeavors to maintain and renew the patents throughout
  the duration of the OUI Agreement. The Company and OUI agreed to inform each other in writing of any misappropriation or infringement
  of any rights to the licensed technology; however, the Company has the first right to take legal action at its own cost in relation to
  any such misappropriation or infringement, but must discuss any proposed legal action with OUI and take into account any legitimate interest
  of OUI in the legal action that it takes. If the Company notifies OUI that it does not intend to take legal action in such matters, OUI
  may take any legal action at its own cost. All profits or damages recovered after unrecovered costs and expenses are deducted are treated
  as net sales for which royalties would be due.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">OUI makes no warranties at all with regard to
  the Licensed Technology or whether use of it will infringe third party rights. The Company is required to indemnify OUI and Oxford University
  from all third party claims, damages, and liabilities asserted by third parties arising directly or indirectly from use of the Licensed
  Technology; marketing of Licensed Products; or breach of the OUI Agreement. The OUI Agreement is governed by English law and the parties
  agreed to submit to the exclusive jurisdiction of English Courts for resolution of any disputes arising out of or in connection with the
  OUI Agreement, with the exception of actions relating to intellectual property disputes or confidential information which may be brought
  in any court of competent jurisdiction.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 62; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Either party may terminate the OUI Agreement for
  an uncured material breach. The Company may terminate the OUI Agreement for any reason at any time upon six&nbsp;months&rsquo; written
  notice expiring after the third anniversary of the OUI Agreement. OUI may terminate immediately if the Company has a petition presented
  for its winding-up or passes a resolution for winding up other than for a bona fide amalgamation or reconstruction or compounds with its
  creditors or has a receiver or administrator appointed. OUI may also terminate if the Company opposes or challenges the validity of any
  of the patents or applications in the Licensed Technology; raises the claim that the know-how of the Licensed Technology is not necessary
  to develop and market Licensed Products; or in OUI&rsquo;s reasonable opinion, is taking inadequate or insufficient steps develop or market
  Licensed Products and does not take any further steps that OUI requests by written notice within a reasonable time.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><FONT STYLE="font-family: Times New Roman, Times, Serif; background-color: white">Pursuant
  to the terms of the OUI Agreement, the Company entered into a sponsored research agreement (the &ldquo;OUI SRA&rdquo;), dated December&nbsp;18,
  2019 with Oxford University for research related to the OUI Agreement for a period of&nbsp;three&nbsp;years for a total of &pound;420,000.
  The Company prepaid the full amount to Oxford of $554,802&nbsp;for the services in January&nbsp;2020.</FONT> Pursuant to an amendment
  to the SRA (the &ldquo;OUI SRA Amendment&rdquo;), dated May 16, 2022, the term of the research under the SRA was extended for an additional
  18 months, culminating on June 18, 2024. The OUI SRA Amendment also requires that the Company provide additional funding in connection
  with the research in the amount of &pound;53,500.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Exclusive License Agreement between St. Jude Children&rsquo;s
  Research Hospital, Inc.&nbsp;&amp; Blue Water Vaccines Inc.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On January&nbsp;27, 2020 (the &ldquo;Effective
  Date&rdquo;), the Company entered into an exclusive, worldwide license agreement with St. Jude Children&rsquo;s Research Hospital, Inc.
  (&ldquo;St. Jude&rdquo;), pursuant to which St. Jude granted the Company an exclusive license to develop licensed products and produce
  vaccines for use in humans (&ldquo;St. Jude Agreement&rdquo;) under U.S.&nbsp;Provisional Patent Application No. 61/537,290 (U.S.&nbsp;Patent
  No. 9,265,819 issued on February&nbsp;23, 2016), and U.S.&nbsp;Provisional Patent Application No. 62/817,748 (filed March&nbsp;13, 2019),
  and any issued patents, divisions, continuations, continuations-in-part, to the extent that the claims are directed to subject matter
  described in the above-referenced patent applications and are entitled to the priority date of the existing patent rights, re-examinations,
  substitutions, renewals, restorations, additions, or registrations thereof, as well as non-United&nbsp;States counterparts thereof, and
  extensions and supplementary protection certificates thereon (&ldquo;Patent Rights&rdquo;), all as set forth in the below chart:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-right: 3pt; padding-bottom: 1.5pt"><B>U.S.&nbsp;Patent<BR>
  Application&nbsp;No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; text-align: center"><B>U.S.&nbsp;Patent No.</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 20%; border-bottom: black 1.5pt solid; text-align: center"><B>Granted Claim Type</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 15%; border-bottom: black 1.5pt solid; padding-bottom: 1.5pt; text-align: center"><B>U.S.&nbsp;Expiration</B></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="width: 31%; border-bottom: black 1.5pt solid; text-align: center"><B>Foreign Counterparts</B></TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD STYLE="padding-left: 10pt; text-indent: -10pt">14/345,988</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">9,265,819</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>Compositions and method of treatment</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">9/19/2032</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>none</TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <TD STYLE="padding-left: 10pt; text-indent: -10pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: #CCEEFF">
      <TD STYLE="padding-left: 10pt; text-indent: -10pt">17/602,414<SUP>#</SUP></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">pending</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>pending**</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center">[3/12/2040]*</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD>Pending Applications in: <BR>
  Australia,<BR>
  Brazil, Canada, China, Europe,<BR>
  Hong&nbsp;Kong, Japan and Korea</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">*</TD>
      <TD STYLE="text-align: justify">Projected expiration if patent issues: 20&nbsp;years from earliest non-provisional application filing date.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">#</TD>
      <TD STYLE="text-align: justify">U.S.&nbsp;National stage entry of WO 2020/183420 (PCT/IB2020/052250).</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">**</TD>
      <TD>This is a pending application. Claim type will be determined after U.S.&nbsp;prosecution is complete. The claim type sought includes compositions and method of treatment.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The license is sublicensable consistent with the
  terms and conditions of the St. Jude Agreement, provided that the Company remains responsible for the performance by each of its sublicensees.
  The license is subject to any government rights the United&nbsp;States has reserved, and St. Jude retained the right to make, have made,
  provide and use for St. Jude&rsquo;s non-commercial research and clinical purposes, including the right to distribute St. Jude&rsquo;s
  biological material disclosed and claimed in the Patent Rights for non-profit academic research use to non-commercial entities as is customary
  in the scientific community and to sell the biological materials as research reagents for research use only by the scientific community.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 63; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is required to pay St. Jude milestone
  payments of up to an aggregate of $1.0&nbsp;million upon the achievement of specified development milestones, of approximately $0.2&nbsp;million,
  regulatory milestones, of approximately $0.3&nbsp;million and commercial milestones, of approximately $0.5&nbsp;million (excluding any
  royalty arrangements). In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the
  Company is obligated to pay St. Jude fifteen percent of any sublicense consideration, subject to specified exclusions, but including any
  upfront or milestone fees and including any premium paid by sublicensee over Fair Market Value (as defined in the agreement) for the Company&rsquo;s
  stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In exchange for the licenses, the Company paid
  St. Jude an initial license fee of $15,000 and is required to pay an annual maintenance fee of $10,000 beginning on the first anniversary
  of the Effective Date (which is waived if all of the developmental milestones scheduled for completion before such annual fee is due have
  been achieved), milestone payments, patent reimbursement, and running royalties based on net sales of licensed products under the St.
  Jude Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the St. Jude Agreement, the Company is obligated
  to use commercially reasonable efforts to develop and commercialize the licensed product(s). If the Company fails to achieve the development
  milestones contained in the St. Jude Agreement, and if the Company and St. Jude fail to agree upon a mutually satisfactory revised time
  line, St. Jude will have the right to terminate the St. Jude Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The milestones include the following events: (i)&nbsp;complete
  IND enabling study by 2020; (ii)&nbsp;Initiate animal toxicology study by last half of 2020; (iii)&nbsp;file IND by first half of 2021;
  (iv)&nbsp;complete Phase&nbsp;I Clinical Trial by first half of 2022; (v)&nbsp;commence Phase&nbsp;II Clinical Trial by first half of
  2024; (vi)&nbsp;commence Phase&nbsp;III Clinical Trial by 2026; and, (vii)&nbsp;regulatory approval, U.S.&nbsp;or foreign equivalent by
  2026. Upon achievement of certain development and commercialization milestones, the Company is required to make milestone payments to
  St. Jude between the achievement of certain milestones (commencement of a Phase&nbsp;III clinical trial through first commercial sale).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the Company is obligated to make
  running 4% royalty payments payable, for each licensed product(s)&nbsp;sold by the Company, its affiliates or sublicensees, based on the
  net sales for the duration of the St. Jude Agreement. Furthermore, the Company is obligated to pay a percentage between 15% of other consideration
  received for any sublicenses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On May 11, 2022, the Company and St. Jude entered
  into a first amendment to the St. Jude Agreement (the &ldquo;St. Jude Amendment&rdquo;). The St. Jude Amendment provides for a revised
  development milestone timeline, a one-time license fee of $5,000, and an increase to the royalty rate from 4% to 5%. The St. Jude Amendment
  also provides for an increase to the contingent milestone payments, from $1.0 million to $1.9 million in the aggregate; specifically,
  development milestones of $0.3 million, regulatory milestones of $0.6 million, and commercial milestones of $1.0 million.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company reimbursed St. Jude approximately
  $32,400 for certain patent costs incurred by St. Jude prior to the Effective Date of the St. Jude Agreement, and is obligated to reimburse
  St. Jude for reasonable patent costs incurred by St. Jude subsequent to the Effective Date.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Company is responsible for and shall bear
  all expenses relating to the filing, prosecution, and maintenance of all patent rights licensed under the St. Jude Agreement. The Company
  has the first right to enforce any patent against infringement, and shall keep St. Jude informed of the status of such; however, before
  the Company may commence any action with respect to any such alleged infringement, the Company shall take into consideration the views
  of St. Jude and the potential effect on the public interest.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to initial human testing or first commercial
  sale of a licensed product, and thereafter so long as the licensed products are being sold in any particular country, the Company (and
  its sublicenses) is required to obtain and maintain insurance to cover its indemnity obligations, and to obtain and maintain product liability
  insurance coverage.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 64; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">St. Jude represented and warranted that it has
  good and marketable title to the Patent Rights, but made no other representations and warranties. The term of the agreement commenced
  on the Effective Date, and shall continue, in each country, until the date of expiration of the last to expire valid claim included within
  the Patent Rights in that country. Either party may terminate the St. Jude Agreement in the event the other party (a)&nbsp;files or has
  filed against it a petition under the Bankruptcy Act (among other things) or (b)&nbsp;fails to perform or otherwise breaches its obligations
  under the St. Jude Agreement, and has not cured such failure or breach within sixty (60)&nbsp;days. The Company may terminate for any
  reason on thirty (30)&nbsp;days written notice.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the St. Jude Agreement, the Company
  also entered into a sponsored research agreement (the &ldquo;SRA&rdquo;) dated May&nbsp;3, 2021 with St. Jude for research related to
  the St. Jude Agreement. Pursuant to the SRA, the Company is obligated to pay St. Jude an aggregate amount of $73,073 in two parts, Phase&nbsp;I
  for $57,624 and Phase&nbsp;II for $15,449 and this sponsored research project began during the year ended December&nbsp;31, 2021.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Manufacturing and Supply</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We currently do not own or operate any manufacturing
  facilities, but our strategic partnership with Ology Bioservices, Inc. (which was later acquired by National Resilience, Inc.) (&ldquo;Ology&rdquo;)
  provides us with access to substantial resources to facilitate an independent supply path to the market. Ology is a leading global contract
  manufacturer with deep domain expertise and experience in large and small-scale production of clinical, as well as commercial-stage products.
  We have entered into agreements with Ology to secure capacity, technical expertise and resources to support the production of our products
  and processes that are intended to scale to commercial scale at Ology or other commercial manufacturing sites.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In July&nbsp;2019, we entered into a development
  and manufacturing master services agreement with Ology, which we refer to, as amended, as the Ology Agreement, pursuant to which Ology
  is obligated to perform manufacturing process development and clinical manufacture and supply of components.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Under the Ology Agreement, we will pay Ology agreed
  upon fees for Ology&rsquo;s performance of manufacturing services, and we will reimburse Ology for its out-of-pocket costs associated
  with purchasing raw materials, plus a customary handling fee. The Company entered into an initial Project Addendum on October&nbsp;18,
  2019 and the Company was required to pay Ology an aggregate of approximately $4&nbsp;million. Due to unforeseen delays associated with
  COVID-19, the Company and Resilience entered into a letter agreement dated January&nbsp;9, 2020 to stop work on the project. The Company
  paid Ology $100,000 for services, of which $48,600 remains as prepaid expense as of December&nbsp;31, 2020. The second Project Addendum
  was executed May&nbsp;21, 2021 and the Company is obligated to pay Ology an aggregate amount of approximately $2.8&nbsp;million, plus
  reimbursement for materials and outsourced testing, which will be billed at cost plus 15%. This project began during the year ended December&nbsp;31,
  2021, and the Company has incurred related research and development expenses of approximately $328,000 of which approximately $164,000
  and $115,000 was recorded as accounts payable and accrued expenses, respectively, at December&nbsp;31, 2021. During the three months ended
  March 31, 2022, the Company incurred related research and development expenses of approximately $217,000, and had approximately $332,000
  recorded as related accrued expenses at March 31, 2022.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On April 20, 2022, the Company and Ology entered
  into a first amendment to the second Project Addendum (the &ldquo;Ology Amendment&rdquo;). The Ology Amendment provides for an increase
  to the Company&rsquo;s obligation of $0.3 million, specifically related to regulatory support on the project.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Either party may terminate a Project Addendum
  and/or the Ology Agreement upon the material breach of any provision of this Agreement by the other Party if such breach is not cured
  by the breaching party within thirty&nbsp;(30)&nbsp;calendar&nbsp;days after receipt by the breaching Party of written notice of such
  default. The Company may terminate the Ology Agreement or the associated Project Addendum for any or no reason upon sixty (60)&nbsp;days&rsquo;
  prior written notice to Ology.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Employees</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of May 20, 2022, we had 5 full-time and 7 subcontracted
  employees. None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
  We believe we have good relations with our employees.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Properties and Facilities</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are currently leasing an office located at
  201 E Fifth Street, Suite 1900, Cincinnati, OH&nbsp;45202, which is renewed on a monthly basis. All of our research and development is
  performed on the premises of our third-party providers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Legal Proceedings</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">On April 15, 2022, the Company received a demand
  letter (the &ldquo;Demand Letter&rdquo;) from Boustead. The Demand Letter alleges that the Company breached the Underwriting Agreement
  entered into between Boustead Securities, LLC (&ldquo;Boustead&rdquo;) and the Company, dated February 17, 2022 (the &ldquo;Underwriting
  Agreement&rdquo;) in connection with the Company&rsquo;s initial public offering. The Demand Letter alleges that, by engaging H.C. Wainwright
  &amp; Co., LLC as placement agent in the Company&rsquo;s private placement, consummated in April 2022 (the &ldquo;Private Placement&rdquo;),
  the Company breached the right of first refusal to act as placement agent granted to Boustead under the Underwriting Agreement and, as
  a result of selling securities in the Private Placement, breached the 12-month lock-up obligation following the consummation of the initial
  public offering under the Underwriting Agreement. The Demand Letter requested that the Company rescind the Private Placement. The Company
  has not responded to the Demand Letter and no legal action has been brought by Boustead to date. There can be no assurance as to whether
  any litigation will be commenced against the Company with respect to the demand letter or that, if any such litigation is commenced, the
  Company will not incur material losses due to damages, penalties, costs and/or expenses as a result of such litigation or that any such
  losses will not have a material impact on the Company&rsquo;s financial condition or results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>Summary Risk Factors</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our business is subject to
  a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial
  condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock.
  These risks include, but are not limited to, the following:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We are in the early stages of vaccine development and have a very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We have incurred significant net losses since inception, do not generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. Our stock is a highly speculative investment.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We will require significant additional capital to make the investments we need to execute our longer-term business plan. We estimate that, based on our existing cash as of the date of this registration statement, we have cash on hand sufficient to fund our operations for at least the next 12 months. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations, and we may be unable to continue as a going concern in the long term. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Due to the significant resources required for the development of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates. Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine candidates that may be more profitable or for which there is a greater likelihood of success.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We depend entirely on the success of a limited number of product candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never become profitable.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>The marketing approval process of the U.S.&nbsp;Food and Drug Association, or FDA, is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future product candidates we intend to develop, our business will be substantially harmed.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>The future results of our current or future clinical trials may not support our product candidates&rsquo; claims or may result in the discovery of unexpected adverse side effects.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Even if we obtain regulatory approval of our vaccine candidates, the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in the medical community.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD STYLE="text-align: justify">We may be adversely affected by the ongoing coronavirus pandemic.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We intend to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Our Chief Executive Officer, Chief Financial Officer and other key personnel may allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We may in the future have conflicts with our current or future partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could compete against us more directly, which would harm our business, possibly materially.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD STYLE="text-align: left">We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Some of the intellectual property covered by our licenses concerns patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Healthcare Reform in the United&nbsp;States has been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry. Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Obtaining regulatory approval for clinical trials of our vaccine candidates in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory approval for the pediatric populations are more stringent.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>We are an &ldquo;emerging growth company&rdquo; and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>Our amended and restated certificate of incorporation (&ldquo;Amended and Restated Certificate of Incorporation&rdquo;) and our amended and restated bylaws (&ldquo;Amended and Restated Bylaws&rdquo;), and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>A possible &ldquo;short squeeze&rdquo; due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><U>Other</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: left; text-indent: 0.25in">We were incorporated on October
  22, 2018 under the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati,
  OH 45202, and our telephone number is (513) 620-4101. Our corporate website address is&nbsp;<I>www.bluewatervaccines.com</I>. We make
  available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
  on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of
  the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities
  and Exchange Commission (the &ldquo;SEC&rdquo;). Alternatively, you may also access our reports at the SEC&rsquo;s website at www.sec.gov.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_005"></A>RISK FACTORS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; text-indent: 0.25in">Our business involves a high
  degree of risk and uncertainty, including the following risks and uncertainties:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><I>Investing in our common stock involves a high
  degree of risk. You should carefully consider the following information about these risks before deciding to invest in our common stock.
  The occurrence of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results
  of operations and future growth prospects, as well as our ability to accomplish our strategic objectives. As&nbsp;a result, the trading
  price of our common stock could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently
  known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to our Financial Position and Need for Capital</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are in the early stages of vaccine development and have a
  very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success
  of our business to date and to assess our future viability.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To date, we have devoted substantially all of
  our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support
  of our product development efforts, hiring personnel, licensing and developing our technology and vaccine candidates, organizing and staffing
  our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand
  such activities. As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory
  approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization
  or arrange for a third party to conduct these activities on our behalf. Consequently, any predictions about our future success or viability
  may not be as accurate as they could be if we had a longer operating history.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our current vaccine candidate pipeline includes
  four preclinical programs. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors
  in achieving our business objectives, including with respect to our vaccine candidates. We will need to transition in the future from
  a company with a research and development focus to a company capable of supporting commercial activities and may not be successful in
  such a transition.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have incurred significant net losses since inception, do not
  generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve
  profitability. Our stock is a highly speculative investment.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are a preclinical stage biotechnology vaccine
  company that was incorporated in October 2018. Investment in preclinical stage companies and vaccine development is highly speculative
  because it entails substantial upfront capital expenditures and significant risk that any potential vaccine candidate will not gain regulatory
  approval or become commercially viable. We do not have any products approved for sale and have not generated any revenue from product
  sales. As a result, we are not profitable and have incurred losses in each year since inception. Our net loss was $2.1 million for the
  three months ended March 31, 2022. As of March 31, 2022, we had an accumulated deficit of $8.0 million. We also generated negative operating
  cash flows of $0.9 million for the three months ended March 31, 2022. Our net losses were $3.4 million and $1.6 million for the years
  ended December 31, 2021 and 2020, respectively. As of December 31, 2021, we had an accumulated deficit of $6.0 million.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We expect to continue to spend significant resources
  to fund research and development of, and seek regulatory approvals for, our vaccine candidates. We expect to incur substantial and increasing
  operating losses over the next several&nbsp;years as our research, development, manufacturing, preclinical testing and clinical trial
  activities increase. As a result, our accumulated deficit will also increase significantly. Additionally, there can be no assurance that
  the product candidates currently under development or that may be under development by us in the future will be approved for sale in the
  U.S.&nbsp;or elsewhere. Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized,
  and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability,
  we may be unable to continue our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will require substantial additional funding to finance our
  long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain
  of our development programs or other operations.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of March 31, 2022, we had cash of $18.6 million,
  and as of April 30, 2022, we had cash of $24.2 million. As of December 31, 2021, we had cash of $1.9 million. On April 19, 2022 we closed
  a Private Placement from which we received aggregate gross proceeds of approximately $8.0 million, before deducting placement agent fees
  and other Offering expenses. We estimate that, based on our existing cash as of the date of this registration statement, we have cash
  on hand sufficient to fund our operations for at least the next 12 months. We will need to raise additional capital prior to commencing
  additional pivotal trials for certain of our vaccine candidates. We believe that we will need to raise substantial additional capital
  to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates
  in the long-term. Our business or operating plan may change as a result of many factors currently unknown to us, and we may need to seek
  additional funds sooner than planned. We expect to finance our subsequent cash needs through public or private equity or debt financings,
  third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances
  and licensing arrangements or any combination of these approaches. In addition, we may need to accelerate the growth of our sales capabilities
  and distribution beyond what is currently envisioned, and this would require additional capital.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">However, we may not be able to secure funding
  when we need it or on favorable terms and we may not be able to raise sufficient funds to commercialize our current and future product
  candidates we intend to develop. Our ability to raise additional capital may be adversely impacted by potential worsening global economic
  conditions and the recent disruptions to and volatility in the credit and financial markets in the United&nbsp;States and worldwide, including
  the trading price of common stock, resulting from the ongoing COVID-19 pandemic. Our future capital requirements will depend on many factors,
  including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical development and clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies for our vaccine candidates, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the cost of building a sales force in anticipation of any product commercialization;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for any of our vaccine candidates for which we receive marketing approval;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>any product liability or other lawsuits related to our products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD STYLE="text-align: justify">the expenses needed to attract, hire and retain skilled personnel;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the revenue, if any, received from commercial sales, or sales to foreign governments, of our vaccine candidates for which we may receive marketing approval;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing of any patents or other intellectual property rights;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the expenses needed to attract, hire and retain skilled personnel;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the costs of operating as a public company; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 24px">&nbsp;</TD>
      <TD STYLE="width: 24px">&#9679;</TD>
      <TD>the impact of the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to raise additional funds will depend
  on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available
  on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in
  sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization
  of our vaccine candidates or other research and development initiatives. Our license agreements may also be terminated if we are unable
  to meet the payment obligations or milestones under the agreements. We could be required to seek collaborators for our vaccine candidates
  at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, or relinquish
  or license on unfavorable terms our rights to our vaccine candidates in markets where we otherwise would seek to pursue development or
  commercialization ourselves.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may consider strategic alternatives in order to maximize stockholder
  value, including financings, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business. We may not
  be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may have an adverse impact
  on our vaccine candidates.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may consider all strategic alternatives that
  may be available to us to maximize stockholder value, including financings, strategic alliances, licensing arrangements, acquisitions
  or the possible sale of our business.Our exploration of various strategic alternatives may not result in any specific action or transaction.
  To the extent that this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction.
  There can be no assurance that we will enter into any transaction as a result of the engagement. Furthermore, if we determine to engage
  in a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price.
  We also cannot predict the impact on our stock price if we fail to enter into a transaction.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, we face significant competition in
  seeking appropriate strategic partners, and the negotiation process is time-consuming and complex. Moreover, we may not be successful
  in our efforts to establish a strategic partnership or other alternative arrangements for our vaccine candidates because they may be deemed
  to be at too early of a stage of development for collaborative effort, and third parties may not view our vaccine candidates as having
  the requisite potential to demonstrate safety and efficacy. Any delays in entering into new strategic partnership agreements related to
  our vaccine candidates could delay the development and commercialization of our vaccine candidates in certain geographies for certain
  indications, which would harm our business prospects, financial condition and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we license products or businesses, we may not
  be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company
  culture. We cannot be certain that, following a strategic transaction or license, we will achieve the results, revenue or specific net
  income that justifies such transaction.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Raising additional capital may cause dilution to our existing
  stockholders and investors, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms
  to us.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may seek additional capital through a variety
  of means, including through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing,
  distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt
  securities, or through the issuance of shares under other types of contracts, or upon the exercise or conversion of outstanding options,
  warrants, convertible debt or other similar securities, the ownership interests of our stockholders will be diluted, and the terms of
  such financings may include liquidation or other preferences, anti-dilution&nbsp;rights, conversion and exercise price adjustments and
  other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to
  those of our holders of common stock in terms of the payment of dividends or in the event of a liquidation. In addition, debt financing,
  if available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt,
  making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security interests
  in our assets. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution or licensing arrangements
  with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidates
  or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
  when needed, we may need to curtail or cease our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Due to the significant resources required for the development
  of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates.
  Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine
  candidates that may be more profitable or for which there is a greater likelihood of success.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Due to the significant resources required for
  the development of our vaccine candidates, we must decide which vaccine candidates to pursue and advance and the amount of resources to
  allocate to each. Our decisions concerning the allocation of research, development, management and financial resources toward particular
  vaccine candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.
  Similarly, our potential decisions to delay, terminate, license or collaborate with third parties in respect of certain vaccine candidates
  may subsequently also prove to be less than optimal and could cause us to miss valuable opportunities. If we make incorrect determinations
  regarding the viability or market potential of any of our vaccine candidates or misread trends in the biopharmaceutical industry, in particular
  for vaccines, our business could be seriously harmed. As a result, we may fail to capitalize on viable commercial products or profitable
  market opportunities, be required to forego or delay pursuit of opportunities with other vaccine candidates that may later prove to have
  greater commercial potential than those we choose to pursue or relinquish valuable rights to such vaccine candidates through collaboration,
  licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain
  sole development and commercialization rights.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have identified weaknesses in our internal controls, and we
  cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in
  the future.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a public company, we are subject to the reporting
  requirements of the Exchange Act, and the Sarbanes-Oxley Act. We expect that the requirements of these rules and regulations will continue
  to increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and
  place significant strain on our personnel, systems and resources.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The Sarbanes-Oxley Act requires, among other things,
  that we maintain effective disclosure controls and procedures, and internal control over financial reporting.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not yet have effective disclosure controls
  and procedures, or internal controls over all aspects of our financial reporting. We are continuing to develop and refine our disclosure
  controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we will
  file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our management
  has deemed certain conditions to be material weaknesses in our internal controls. For example, we failed to employ a sufficient number
  of staff to maintain optimal segregation of duties and to provide optimal levels of oversight in order to process financial information
  in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. In addition, we do not
  yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions. Our management
  is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule&nbsp;13a-15(f)&nbsp;under
  the Exchange&nbsp;Act. We will be required to expend time and resources to further improve our internal controls over financial reporting,
  including by expanding our staff to include financial consultants and other qualified resources, which we commenced during the fourth
  quarter of 2021. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify
  or avoid material weaknesses in the future.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our current controls and any new controls that
  we develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international
  expansion. Further, weaknesses in our disclosure controls or our internal control over financial reporting may be discovered in the future.
  Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm
  our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements
  for prior periods. Any failure to implement and maintain effective internal control over financial reporting could also adversely affect
  the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting
  that we will eventually be required to include in our periodic reports that will be filed with the SEC.&nbsp;Ineffective disclosure controls
  and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial
  and other information, which would likely have a negative effect on the market price of our common stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are not currently required to comply with the
  SEC rules that implement Section&nbsp;404 of the Sarbanes-Oxley Act and are therefore not required to make a formal assessment of the
  effectiveness of our internal control over financial reporting for that purpose. We will be required to provide an annual management report
  on the effectiveness of our internal control over financial reporting commencing with our second annual report on Form&nbsp;10-K.&nbsp;Our
  independent registered public accounting firm is not required to audit the effectiveness of our internal control over financial reporting
  until after we are no longer an &ldquo;emerging growth company&rdquo; as defined in the JOBS Act. At such time, our independent registered
  public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control
  over financial reporting is documented, designed or operating.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our ability to use our net operating loss carryforwards and certain
  other tax attributes may be limited, each of which could harm our business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of December&nbsp;31, 2021, we had U.S.&nbsp;federal
  and state net operating loss carryforwards of approximately $4.9&nbsp;million and $5.1&nbsp;million, respectively. Under Sections 382
  and 383 of the Internal Revenue Code, or the Code, if a corporation undergoes an &ldquo;ownership change,&rdquo; the corporation&rsquo;s
  ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research
  tax credits, to offset its post-ownership change income and taxes may be limited. In general, an ownership change will occur when the
  percentage of the Corporation&rsquo;s ownership (by value) of one or more &ldquo;5-percent stockholders&rdquo; (as defined in the Code)
  has increased by more than 50 percent over the lowest percentage owned by such stockholders at any time during the prior three&nbsp;years
  (calculated on a rolling basis). Similar rules may apply under state tax laws. An entity that experiences an ownership change generally
  will be subject to an annual limitation on its pre-ownership change tax loss and credit carryforwards equal to the equity value of the
  corporation immediately before the ownership change, multiplied by the long-term, tax-exempt rate posted monthly by the U.S.&nbsp;Internal
  Revenue Service (subject to certain adjustments). The annual limitation would be increased each year to the extent that there is an unused
  limitation in a prior year. In the event that it is determined that we have in the past experienced an ownership change as a result of
  transactions in our stock, or if we experience one or more ownership changes as a result of future transactions in our stock, then we
  may be limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable
  income that we earn. Any limitations on the ability to use our net operating loss carryforwards and other tax assets could harm our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our insurance coverage may be inadequate or expensive.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are subject to claims in the ordinary course
  of business. These claims may involve substantial amounts of money and involve significant defense costs. It is not possible to prevent
  or detect all activities giving rise to claims and the precautions we take may not be effective in all cases. We maintain voluntary and
  required insurance coverage, including, among others, general liability, property, director and officer, business interruption, cyber
  and data breach. Our insurance coverage is expensive and maintaining or expanding our insurance coverage may have an adverse effect on
  our results of operations and financial condition.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our insurance coverage may be insufficient to
  protect us against all losses and costs stemming from operational and technological failures and we cannot be certain that such insurance
  will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any
  future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence
  of changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance
  requirements, could have an adverse effect on our business, financial condition and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to the Development of our Product Candidates</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We depend entirely on the success of a limited number of product
  candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval
  for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never
  become profitable.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not have any products that have received
  regulatory approval and may never be able to develop marketable product candidates. We expect that a substantial portion of our efforts
  and expenses over the next few&nbsp;years will be devoted to the development of our product candidates; specifically, the commencement
  of Phase&nbsp;I clinical trials for our vaccine candidates. As a result, our business currently depends heavily on the successful development,
  regulatory approval and, if approved, commercialization of these product candidates. We cannot be certain that our product candidates
  will receive regulatory approval or will be successfully commercialized even if they receive regulatory approval. The research, testing,
  manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain,
  subject to comprehensive regulation by the FDA and similar foreign regulatory authorities. Before obtaining regulatory approvals for the
  commercial sale of any product candidate, we must demonstrate through pre-clinical studies and clinical trials that the product candidate
  is safe and effective for use in each target indication. Vaccine development is a long, expensive and uncertain process, and delay or
  failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates in the
  United&nbsp;States will prevent us from commercializing and marketing our product candidates. The success of our product candidates will
  depend on several additional factors, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">completing clinical trials that demonstrate their efficacy and safety;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">receiving marketing approvals from applicable regulatory authorities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">completing any post-marketing studies required by applicable regulatory authorities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">establishing commercial manufacturing capabilities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">launching commercial sales, marketing and distribution operations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the prevalence and severity of adverse events experienced with our product candidates;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">acceptance of our product candidates by patients, the medical community and third-party payors;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">a continued acceptable safety profile following approval;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">obtaining and maintaining healthcare coverage and adequate reimbursement for our product candidates;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>competing effectively with other therapies, including with respect to the sales and marketing of our product candidates, if approved; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of these factors are beyond our control,
  including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual
  property rights and changes in the competitive landscape. It is possible that none of our product candidates will ever obtain regulatory
  approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in
  a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory
  approval or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and results
  of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The marketing approval process of the FDA is lengthy, time consuming
  and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future
  product candidates we intend to develop, our business will be substantially harmed.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are at a very early stage of development for
  all of our product candidates. The product candidates we intend to develop have not gained marketing approval in the U.S., and we cannot
  guarantee that we will ever have marketable products. Our business is substantially dependent on our ability to complete the development
  of, obtain marketing approval for, and successfully commercialize our current and future product candidates in a timely manner. We cannot
  commercialize our product candidates in the United&nbsp;States without first obtaining approval from the FDA to market each product candidate.
  Our product candidates could fail to receive marketing approval for many reasons, including among others:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the FDA may disagree with the design or implementation of our clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>Our clinical trials for our product candidate(s)&nbsp;must be successful if we are to seek and obtain regulatory marketing application through the submission of a new Biological License Application (BLA) and marketing authorization application (MAA) with the U.S.&nbsp;Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. Advanced clinical trials are often not successful even if prior trials were successful, and even if we are able to conduct advanced clinical trials and those trials are successful, we may not obtain necessary regulatory approvals for our product candidate(s)&nbsp;or we may be unable to successfully commercialize our products even if we receive the necessary regulatory approvals</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, the process of seeking regulatory
  approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort and expense
  incurred, approval is never guaranteed. If we are not successful in obtaining timely approval of our product candidates from the FDA,
  we may never be able to generate significant revenue and may be forced to cease operations. The new Biological License Application, or
  BLA, process is costly, lengthy and uncertain. Any BLA application filed by us will have to be supported by extensive data, including,
  but not limited to, technical, pre-clinical, clinical, manufacturing and labelling data, to demonstrate to the FDA&rsquo;s satisfaction
  the safety and efficacy of the product for its intended use.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In order to commence a clinical trial in the United&nbsp;States,
  we will be required to seek FDA acceptance of an IND for each of our product candidates. We cannot be sure any IND we submit to the FDA,
  or any similar clinical trial application we submit in other countries, will be accepted. If we will be required by regulatory authorities
  to conduct additional preclinical testing prior to filing an IND or similar application to clinically evaluate any of our product candidates,
  this may result in delay in our product candidate development. The results of any such preclinical testing may not be positive and may
  not support an application to study any of our product candidates in additional clinical trials.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is possible that the FDA or EMA will not view
  our ongoing or planned trials as providing adequate support for future clinical trials or for an application for marketing approval, for
  any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results. If we
  are unable to confirm or replicate the results of our trials in larger patient group or if negative results are obtained, we would likely
  be further delayed or prevented from advancing further clinical development any of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the FDA or EMA may disagree with
  the sufficiency of our proposed reliance upon the preclinical, manufacturing or clinical data generated by third-party academic-sponsored
  trials, or our interpretation of preclinical, manufacturing or clinical data from our ongoing trials. If so, the FDA or EMA may require
  us to obtain and submit additional preclinical, manufacturing or clinical data.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Obtaining approvals from the FDA and from the
  regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome. The FDA and other agencies
  could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming
  actions, or it could simply deny our applications. In addition, even if we obtain a BLA approval or pre-market approvals in other countries,
  the approval could be revoked or other restrictions imposed if post-market data demonstrate safety issues or lack of effectiveness. We
  cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals, our financial
  condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited. Additionally,
  even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful
  commercialization or profitability.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may encounter substantial delays in completing our clinical
  studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of
  applicable regulatory authorities.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is impossible to predict if or when our current
  or future product candidates, will prove safe or effective in humans or&nbsp;will&nbsp;receive regulatory approval. Before obtaining marketing
  approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate
  the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome.
  We&nbsp;cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A&nbsp;failure of
  one or more clinical studies can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development
  include:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delays in reaching, or failing to reach, a consensus with regulatory agencies on study design;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delays in recruiting a sufficient number of suitable patients to participate in our clinical studies;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">failure by our&nbsp;CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">failure to perform in accordance with the FDA&rsquo;s good clinical practices, or GCPs, or applicable regulatory guidelines in other countries;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delays in having patients complete participation in a study or return for post-treatment follow-up;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">clinical study sites or patients dropping out of a study;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">delay or failure to address any patient safety concerns that arise during the course of a trial;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">unanticipated costs or increases in costs of clinical trials of our product candidates;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">occurrence of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits; or</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We could also encounter delays if a clinical trial
  is suspended or terminated by us, by the Institutional Review Board, or IRB, or the Ethics Commission of the institutions in which such
  trials are being conducted, by an independent Safety Review Board, or SRB, for such trial or by the FDA or other regulatory authorities.
  Such authorities&nbsp;may&nbsp;suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical
  trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site
  by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects,
  failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate
  funding to continue the clinical trial.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any inability to successfully complete pre-clinical
  and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory
  and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes to our product candidates,
  we may need to conduct additional studies to bridge our modified product candidates to earlier versions.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Clinical study delays could also shorten any periods
  during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market
  before we do, which could impair our ability to successfully commercialize our product candidates.&nbsp;In addition, any delays in completing
  our clinical trials will increase our costs, slow down&nbsp;our&nbsp;product candidates&rsquo; development and approval process and jeopardize
  our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business, financial condition
  and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may
  also ultimately lead to the denial of regulatory approval of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The outcome of pre-clinical studies and early
  clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily
  predict final results. Further, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many
  companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless
  failed to obtain marketing approval.&nbsp;If the results of our clinical studies are inconclusive or if there are safety concerns or adverse
  events associated with our product candidates, we may:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">be delayed in obtaining marketing approval for our product candidates, if approved at all;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">obtain approval for indications or patient populations that are not as broad as intended or desired;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">be required to change the way the product is administered;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">be sued; or</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">experience damage to our reputation.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, our product candidates could potentially
  cause other adverse events that have not yet been predicted. The inclusion of ill patients in our clinical studies may result in deaths
  or other adverse medical events due to other therapies or medications that such patients may be using. As described above, any of these
  events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize
  our products.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Obtaining and maintaining regulatory approval of our vaccine
  candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our vaccine candidates in
  other jurisdictions.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Obtaining and maintaining regulatory approval
  of our vaccine candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any
  other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory
  approval process in others. For example, even if the FDA grants marketing approval of a vaccine candidate, comparable regulatory authorities
  in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the vaccine candidate in those countries. Approval
  procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those
  in the United&nbsp;States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction
  may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United&nbsp;States, a vaccine
  candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we
  intend to charge for our products is also subject to approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may also submit marketing applications in other
  countries. Regulatory authorities in jurisdictions outside of the United&nbsp;States have requirements for approval of vaccine candidates
  with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign
  regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction
  of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable
  marketing approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates
  will be harmed.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Modifications to our products may require new BLA approvals.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once a particular product receives FDA approval,
  expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals, including
  additional IND and BLA submissions and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.
  If the FDA requires new approvals for a particular use or indication, we may be required to conduct additional clinical studies, which
  would require additional expenditures and harm our operating results. If the products are already being used for these new indications,
  we may also be subject to significant enforcement actions. Conducting clinical trials and obtaining approvals can be a time-consuming
  process, and delays in obtaining required future approvals could adversely affect our ability to introduce new or enhanced products in
  a timely manner, which in turn would harm our future growth.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Additional delays to the completion of clinical studies may result
  from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences
  in the given trial</I></B><I>.</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Each modification to the protocol during a clinical
  trial has to be submitted to the FDA.&nbsp;This could result in the delay or halt of a clinical trial while the modification is evaluated.
  In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the
  clinical trial are not poolable because the same protocol was not used throughout the trial. This might require the enrollment of additional
  subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product. Any such delay could have
  a material adverse effect on our business and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>There can be no assurance that the data generated from our clinical
  trials using modified protocols will be acceptable to the FDA or other regulatory authorities.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There can be no assurance that the data generated
  using modified protocols will be acceptable to the FDA or other regulatory authorities or that if future modifications during the trial
  are necessary, that any such modifications will be acceptable to the FDA or other regulatory authorities. If the FDA or other regulatory
  authorities believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they
  evaluate additional information regarding the change.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Serious injury or death resulting from a failure
  of our product candidates during current or future clinical trials could also result in the FDA or other regulatory authority delaying
  our clinical trials or denying or delaying approval of a product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even though an adverse event may not be the result
  of the failure of our product candidate, the FDA or other regulatory authority could delay or halt a clinical trial for an indefinite
  period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any delay or termination of our current or future
  clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from the FDA
  or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial,
  and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase
  in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization
  of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will depend on enrollment and retention of patients in our
  clinical trials for our product candidates. If we experience delays or difficulties enrolling or retaining patients in our clinical trials,
  our research and development efforts and business, financial condition, and results of operations could be materially adversely affected.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Successful and timely completion of clinical trials
  will require that we enroll and retain a sufficient number of patient candidates. Any clinical trials we conduct may be subject to delays
  for a variety of reasons, including as a result of patient enrollment taking longer than anticipated, patient withdrawal, or adverse events.
  These types of developments could cause us to delay the trial or halt further development.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our clinical trials will compete with other clinical
  trials that are in the same therapeutic areas as our product candidates, and this competition reduces the number and types of patients
  available to us, as some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by
  one of our competitors. Moreover, enrolling patients in clinical trials for diseases in which there is an approved standard of care is
  challenging, as patients will first receive the applicable standard of care. Many patients who respond positively to the standard of care
  do not enroll in clinical trials. This may limit the number of eligible patients able to enroll in our clinical trials who have the potential
  to benefit from our product candidates and could extend development timelines or increase costs for these programs. Patients who fail
  to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates. However, these
  prior treatment regimens may render our therapies less effective in clinical trials.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because the number of qualified clinical investigators
  and clinical trial sites is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our
  competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Patient enrollment depends on many factors, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the size and nature of the patient population;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the severity of the disease, condition or infection under investigation;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">eligibility criteria for the trial;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the proximity of patients to clinical sites;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the design of the clinical protocol;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the ability to obtain and maintain patient consents;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">perceived risks and benefits of the product candidate under evaluation;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the ability to recruit clinical trial investigators with the appropriate competencies and experience;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the availability of competing clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the availability of such patients during the COVID-19 pandemic;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the availability of new drugs approved for the indication the clinical trial is investigating; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">clinicians&rsquo; and patients&rsquo; perceptions as to the potential advantages of the drug being studied in relation to other available therapies.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These factors may make it difficult for us to
  enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical
  trial of our product candidates will increase our costs, slow down our product candidate development and approval process, and delay or
  potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause, or lead
  to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our
  product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Conducting successful clinical studies may require the enrollment
  of large numbers of patients, and suitable patients may be difficult to identify and recruit.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Patient enrollment in clinical trials and completion
  of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial
  protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability
  of appropriate clinical trial investigators; support staff; and the proximity of patients to clinical sites and ability to comply with
  the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged
  from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up
  to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are
  not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to
  participate in contemporaneous clinical trials of competitive products.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The results of our future clinical trials may not support our
  product candidates&rsquo; claims or may result in the discovery of unexpected adverse side effects.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if our clinical trials are completed as planned,
  we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will agree with
  our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will
  be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical
  trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses. If the FDA concludes
  that the clinical trials for any product for which we might seek approval, has failed to demonstrate safety and effectiveness, we would
  not receive FDA approval to market that product in the United&nbsp;States for the indications sought.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, such an outcome could cause us to
  abandon a product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing
  of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues. It
  is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of our product
  candidates&rsquo; profiles.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Adverse events involving our products may lead the FDA or other
  regulatory authorities to delay or deny approval for our products or result in product recalls that could harm our reputation, business
  and financial results.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, if any of our product candidates
  receives marketing approval, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, and other non-U.S.&nbsp;regulatory
  authorities could impose other specific obligations as a condition of approval to ensure that the benefits outweigh its risks, which may
  include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan
  to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if we or
  others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences
  could result, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">regulatory authorities may suspend or withdraw approvals of such a product candidate;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">regulatory authorities may require additional warnings or limitations of use in product labeling;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>we may be required to change the way a product candidate is distributed, dispensed, or administered or conduct additional clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">we could be sued and held liable for harm caused to patients; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">our reputation may suffer.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any of these events could prevent us from achieving
  or maintaining market acceptance of our product candidates and could significantly harm our business, prospects, financial condition and
  results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Once a product receives FDA approval, the agency
  has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects
  in design or manufacture. The authority to require a recall must be based on an FDA finding that there is a reasonable probability that
  the product would cause serious injury or death. Manufacturers may, under their own initiative, recall a product if any material deficiency
  in a product is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side
  effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues.
  Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and
  results of operations. The FDA requires that certain classifications of recalls be reported to FDA within ten working&nbsp;days after
  the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.&nbsp;We
  may initiate voluntary recalls involving our products in the future. A future recall announcement could harm our reputation with customers
  and negatively affect our sales. In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report
  the recalls when they were conducted.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if we obtain regulatory approval of our vaccine candidates,
  the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in
  the medical community.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if any of our vaccine candidates receive
  marketing approval, they may fail to receive recommendations for use by regulators or advisory boards that recommend vaccines, or gain
  market acceptance by physicians, patients, third-party payors and others in the medical community. If such vaccine candidates do not achieve
  an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance
  of any vaccine candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>receiving CDC and ACIP recommendations for use, as well as recommendations of comparable foreign regulatory and advisory bodies;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">prevalence and severity of the disease targets for which our vaccine candidates are approved;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">physicians, hospitals, third-party payors and patients considering our vaccine candidates as safe and effective;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the potential and perceived advantages of our vaccine candidates over existing vaccines, including with respect to spectrum coverage or immunogenicity;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the prevalence and severity of any side effects;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">product labeling or product insert requirements of the FDA or comparable foreign regulatory and advisory bodies;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>limitations or warnings contained in the labeling approved by the FDA or comparable foreign regulatory and advisory bodies;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the timing of market introduction of our vaccine candidates as well as competitive products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the cost of treatment in relation to alternative treatments;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the availability of coverage and adequate reimbursement and pricing by third-party payors, including government authorities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the willingness of patients to pay&nbsp;out-of-pocket&nbsp;in the absence of coverage and adequate reimbursement by third-party payors, including government authorities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>relative convenience and ease of administration, including as compared to competitive vaccines and alternative treatments; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the effectiveness of our sales and marketing efforts.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, the CDC and ACIP develop
  vaccine recommendations for both children and adults, as do similar agencies around the world. To develop its recommendations, ACIP forms
  working groups that gather, analyze and prepare scientific information. The ACIP also considers many of the factors above, as well as
  myriad additional factors such as the value of vaccination for the target population regarding the outcomes, health economic data and
  implementation issues. ACIP recommendations are also made within categories, such as in an age group or a specified risk group. For example,
  the ACIP may determine that a preferred recommendation in a smaller child population may be more economical than recommending vaccinations
  for a larger adult population, which could adversely impact our market opportunity.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">New pediatric vaccines that receive an ACIP preferred
  recommendation are almost universally adopted, and adult vaccines that receive a preferred recommendations are widely adopted. For example,
  in 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults ages 65&nbsp;years and older against pneumococcal
  disease, which caused Prevnar 13 to become the standard of care along with continued use of Pneumovax 23. ACIP can also modify its preferred
  recommendation. For instance, in June&nbsp;2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend Prevnar
  13 for adults 65 and older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation,
  which means the decision to vaccinate should be made at the individual level between health care providers and their patients. Pfizer
  recently noted that this revised recommendation is expected to have a negative effect on Prevnar 13 revenue for future periods.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our vaccine candidates are approved but fail
  to receive CDC and ACIP recommendations, or recommendations of other comparable foreign regulatory and advisory bodies, or achieve market
  acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able
  to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance
  over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or
  render our products obsolete.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Obtaining regulatory approval for clinical trials of our vaccine
  candidates in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory
  approval for the pediatric populations are more stringent.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pediatric vaccine candidates&rsquo; development
  may require additional studies to determine safe dosing and long-term monitoring. These additional studies may require investment of significant
  additional resources beyond those required for regulatory approval of the vaccines in adults. Approval of our vaccine candidates may be
  delayed due to these additional requirements and this may have an adverse effect on the commercial prospects of our vaccine candidates,
  especially our pediatric vaccine candidate, BWV-201, as well as delay our ability to generate product revenue, possibly materially. In
  addition, as a result of COVID-19 (or other potential pandemics), there may be a smaller pool of children from which we can enroll for
  our clinical trials. We cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric
  populations or the adult population.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if we are able to commercialize our product candidates,
  such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,
  which would harm our business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The regulations that govern marketing approvals,
  pricing, coverage and reimbursement for new drugs vary widely from country to country. In the United&nbsp;States, new and future legislation
  may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.
  Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins
  after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject
  to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for
  a vaccine in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time
  periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations
  may hinder our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing
  approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to commercialize our current and any
  future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products
  and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other
  third-party payors. Third-party payors decide which vaccines they will pay for and establish reimbursement levels. A significant trend
  in the U.S.&nbsp;healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to
  control costs by limiting coverage and the amount of payment for particular vaccines. Increasingly, third-party payors are requiring that
  drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage
  and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement
  may not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate
  for which we obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may
  not be able to successfully commercialize any product candidate for which we obtain marketing approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There may be significant delays in obtaining coverage
  and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved
  by the FDA or similar regulatory authorities outside the United&nbsp;States. Moreover, eligibility for coverage and reimbursement does
  not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,
  sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may
  not be made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under
  which it is used may be based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing
  payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs
  or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold
  at lower prices than in the United&nbsp;States. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations
  in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded
  programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our
  ability to raise capital needed to commercialize our approved products and our overall financial condition.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Any product candidate for which we obtain marketing approval
  could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with
  regulatory requirements or if we experience unanticipated problems with our products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any product candidate for which we obtain marketing
  approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities
  for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements
  include submissions of promotional materials and safety and other post-marketing information and reports, registration and listing requirements,
  current Good Manufacturing Practice (&ldquo;cGMP&rdquo;) requirements for product facilities, quality assurance and corresponding maintenance
  of records and documents and requirements regarding the distribution of samples to physicians and related recordkeeping. Even if marketing
  approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may
  be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the
  safety or efficacy of the medicine. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are
  marketed only for the approved indications and in accordance with the provisions of the approved labeling. However, companies may share
  truthful and not misleading information that is otherwise consistent with the product&rsquo;s FDA approved labeling. The FDA imposes stringent
  restrictions on manufacturers&rsquo; communications regarding off-label use and if we do not comply with these restrictions, we may be
  subject to enforcement actions.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, later discovery of previously unknown
  problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements,
  may result in, among other things:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">restrictions on such products, manufacturers or manufacturing processes or facilities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">restrictions on the labeling, marketing, distribution or use of a product;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">warning or untitled letters;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">withdrawal or recall of the products from the market;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">refusal to approve pending applications or supplements to approved applications that we submit;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">fines, restitution or disgorgement of profits or revenue;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">suspension or withdrawal of marketing approvals;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">refusal to permit the import or export of our products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">product seizure; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">injunctions or the imposition of civil or criminal penalties.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Failure to obtain regulatory approvals in foreign jurisdictions
  will prevent us from marketing our products internationally.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We intend to market future products in international
  markets. In order to market our future products in regions such as the European Economic Area, or EEA, Asia Pacific, or APAC, and many
  other foreign jurisdictions, we must obtain separate regulatory approvals.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">For example, in the EEA, medicinal products can
  only be commercialized after obtaining a Marketing Authorization, or MA.&nbsp;Before granting the MA, the European Medicines Agency or
  the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of
  scientific criteria concerning its quality, safety and efficacy. In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA,
  of the Ministry of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug
  product may be marketed in Japan.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have had limited interactions with foreign
  regulatory authorities. The approval procedures vary among countries and can involve additional clinical testing, and the time required
  to obtain approval may differ from that required to obtain FDA approval. Moreover, clinical studies conducted in one country may not be
  accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other
  countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign
  countries or by the FDA.&nbsp;However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on
  the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.
  We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even
  if we file we may not receive necessary approvals to commercialize our products in any market.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If our products do not receive favorable third-party reimbursement,
  or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not generate significant revenues.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to commercialize our products will
  depend in part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations and products and related
  treatments are obtained by governmental authorities, private health insurers and other organizations, such as Health Maintenance Organizations,
  or HMOs. Reimbursement from third parties depends greatly on our ability to present data which demonstrate positive outcomes and reduced
  utilization of other products or services as well as cost data which show that treatment costs using the new product are equal to or less
  than what is currently covered for other products. If our products do not receive favorable third-party reimbursement and patients are
  unwilling or unable to pay for our products out-of-pocket, it could limit our revenues and harm our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The continuing efforts of government and insurance
  companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect
  our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative
  partners and the availability of capital. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals
  is subject to government control. In the United&nbsp;States, recent federal and state government initiatives have been directed at lowering
  the total cost of health care. In March&nbsp;2010, President Obama signed into law the Patient Protection and Affordable Care Act, a sweeping
  law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud
  and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry
  and impose additional health policy reforms. Federal and state legislatures will likely continue to focus on health care reform, controlling
  the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems. While we cannot predict whether any such
  legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially harm our business,
  financial condition and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to our Business and Industry</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be adversely affected by the ongoing coronavirus pandemic.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The outbreak of the novel coronavirus COVID-19
  (&ldquo;COVID-19&rdquo;) has evolved into a global pandemic. The coronavirus has spread to many regions of the world. The extent to which
  the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be
  accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus
  or treat its impact, among others.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a result of the continuing spread of COVID-19,
  our business operations could be delayed or interrupted. Currently, we operate virtually, i.e., our program activities are and will continue
  to be carried out, on our behalf, by competent contract research organizations (CROs) with expertise in pre-clinical, clinical and/or
  chemistry and manufacturing areas. Due to COVID-19, our planned project timelines may be delayed due to reduced availability of human
  resources or critical supplies needed to carry out such plans. Due to shelter-in-place/stay-at-home&nbsp;orders and other government restrictions,
  our employees conducting research and development or manufacturing activities at external vendor locations across the globe may not be
  able to access their laboratory or manufacturing space which may result in our core activities being significantly limited or curtailed,
  possibly for an extended period of time.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, our clinical trials may be affected
  by the COVID-19 pandemic. Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of
  clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,
  federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the COVID-19
  pandemic. If the coronavirus continues to spread, some participants and clinical investigators may not be able to execute clinical trial
  protocols per the expected timelines. The new mutations of the virus may also make it harder for us to predict the exact impact (if any)
  on the progression of COVID-19 on our development programs. For example, quarantines or other travel limitations (whether voluntary or
  required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable
  to conduct our clinical trials. Further, if the spread of the COVID-19 pandemic continues and our operations are adversely impacted, we
  risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully
  recoverable or adequately covered by insurance.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Infections and deaths related to the pandemic
  may disrupt the United&nbsp;States&rsquo; healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources
  away from, or materially delay FDA review or review by other regulatory agencies and/or approval with respect to, our clinical trials.
  It is unknown how long these disruptions could continue, were they to occur. Any elongation or&nbsp;de-prioritization&nbsp;of our clinical
  trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product
  candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The spread of the coronavirus, which has caused
  a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have
  a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult
  to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which
  may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained
  adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of
  our common stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ultimate impact of the current pandemic, or
  any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts
  on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects
  could have a material impact on our operations, and we will continue to monitor the situation closely.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our reliance on third parties heightens the risks faced by our
  business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We rely on suppliers, vendors and partners for
  certain key aspects of our business, including support for information technology systems and certain human resource functions. We do
  not control these partners, but we depend on them in ways that may be significant to us. If these parties fail to meet our expectations
  or fulfill their obligations to us, we may fail to receive the expected benefits. In addition, if any of these third parties fails to
  comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible
  for such violations as well. This risk is particularly serious in emerging markets, where corruption is often prevalent and where many
  of the third parties on which we rely do not have internal compliance resources comparable to our own. Any such failures by third parties,
  in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We rely on, and intend to continue to rely on third parties to
  conduct our pre-clinical testing, research and clinical trials, and those third parties may not perform satisfactorily, including failing
  to meet deadlines for the completion of such trials, research or testing.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have been relying on third parties for our
  preclinical studies, and we expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical
  data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects
  of our research and pre-clinical testing. These third parties may terminate their engagements with us at any time. If these third parties
  do not successfully carry out their duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements
  or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates
  and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. Furthermore, these third
  parties may also have relationships with other entities, some of which may be our competitors. If we are required to enter into alternative
  arrangements, it could delay our product development activities.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our reliance on third parties for research and
  development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we
  will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan
  and protocols for the trial. Moreover, the FDA and other international regulatory authorities require us to comply with GCP standards
  for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate
  and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical
  trials and post the results of completed clinical trials on a government-sponsored database, available at <I>www.clinicaltrials.gov</I>,
  within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Upon commercialization of our products, we may be dependent on
  third parties to market, distribute and sell our products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our ability to receive revenues may be dependent
  upon the sales and marketing efforts of any future co-marketing partners and third-party distributors. At this time, we have not entered
  into an agreement with any commercialization partner and only plan to do so prior to commercialization. If we fail to reach an agreement
  with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it may
  have a negative impact on our business, financial condition and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We have no experience manufacturing product candidates on a clinical
  or commercial scale and will be dependent on third parties for the manufacture of our product candidates. If we experience problems with
  any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell
  any approved products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not have any manufacturing facilities. We
  expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply
  of any product candidate for which we obtain marketing approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may be unable to establish agreements with
  third-party manufacturers for clinical or commercial supply on terms favorable to us, or at all. Even if we are able to establish agreements
  with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">reliance on the third party for regulatory compliance and quality assurance;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Third-party manufacturers may not be able to comply
  with U.S.&nbsp;cGMPs or similar regulatory requirements outside the United&nbsp;States. Our failure, or the failure of our third-party
  manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates
  or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties,
  delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and
  criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any product that we develop may compete with other
  product candidates and products for access to these manufacturing facilities. There are a limited number of manufacturers that operate
  under cGMPs and that might be capable of manufacturing for us.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any performance failure on the part of our manufacturers,
  including a failure that may not relate specifically to our product candidates or approved products, could delay clinical development
  or marketing approval or adversely impact our ability to generate commercial sales. If our contract manufacturers cannot perform as agreed,
  we may be required to replace that manufacturer.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our anticipated future dependence upon others
  for the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability
  to commercialize any product candidates that receive marketing approval on a timely and competitive basis.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Furthermore, we expect to rely on third parties
  to release, label, store and distribute drug supplies for our clinical trials. Any performance failure on the part of these third parties,
  including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development
  or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, our manufacturers and suppliers may
  experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of
  supply of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Manufacturing&nbsp;risks may adversely affect our ability to
  manufacture our product and could reduce our gross margin and profitability.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our business strategy depends on our ability to
  manufacture our product candidates in sufficient quantities and on a timely basis so as to meet our obligations with respect to our clinical
  trials and upon marketing approval, to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements
  and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>quality or reliability defects in product components that we source from third-party suppliers, including&nbsp;manufacturing&nbsp;compliance with federal and state regulations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">our failure to increase production of products to meet demand;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>our inability to modify production lines to enable us to efficiently produce future products or implement changes in current products in response to regulatory requirements; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">Potential damage to or destruction of our&nbsp;manufacturing&nbsp;equipment or&nbsp;manufacturing&nbsp;facility.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If demand for our product candidates increases
  in the future, we will have to invest additional resources to purchase components, hire and train employees, and enhance our&nbsp;manufacturing&nbsp;processes.
  If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins
  could fluctuate or decline. In addition, although we expect some of our product candidates in development to share product features and
  components,&nbsp;manufacturing&nbsp;of some of our product candidates may require the modification of our production lines, the hiring
  of specialized employees, the identification of new suppliers for specific components, or the development of new&nbsp;manufacturing&nbsp;technologies.
  It may not be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates
  commercially viable. Any of these factors may affect our ability to manufacture our product and could reduce our gross margin and profitability.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We maintain single supply relationships for certain key components,
  and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its&nbsp;manufacturing&nbsp;process
  increases.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are dependent on sole suppliers or a limited
  number of suppliers for certain components that are integral to its finished products. If these or other suppliers encounter financial,
  operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish or qualify replacement
  sources of supply and could face production interruptions, delays and inefficiencies. In addition, technology changes by our vendors could
  disrupt access to required&nbsp;manufacturing&nbsp;capacity or require expensive, time consuming development efforts to adapt and integrate
  new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipment and materials
  in sufficient quantities to support our growth. Any one of these factors could harm our business and growth prospects.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may not be able to manage our&nbsp;manufacturing&nbsp;and
  supply chain effectively, which would harm our results of operations.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We must accurately forecast our clinical trial
  obligations, and, in the future, market demand, for our product candidates in order to have adequate product inventory available to fulfil
  our timeline and customer orders timely. Our forecasts will be based on multiple assumptions that may cause our estimates to be inaccurate,
  and thus affect our ability to ensure adequate manufacturing capability to satisfy product candidate needs or market demand. Any material
  delay in our ability to obtain timely product inventories from our manufacturing facility and our ingredient suppliers could prevent us
  from satisfying increased consumer demand for our products, resulting in material harm to our clinical trials, brand and business. In
  addition, we will need to continuously monitor our inventory and product mix against forecasted demand to avoid having inadequate product
  inventory or having too much product inventory on hand. If we are unable to manage our supply chain effectively, our operating costs may
  increase materially.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may in the future have conflicts with our current or future
  partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may in the future have conflicts with our current
  or future partners or third party providers, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement
  of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual
  property developed during our collaboration. If any conflicts arise with any of our partners, such partner may act in a manner that is
  adverse to our best interests. Any such disagreement could result in one or more of the following, each of which could delay or prevent
  the development or commercialization of our current and future product candidates, and in turn prevent us from generating revenues:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">attempts by either party to terminate the agreement.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our product candidates may face competition sooner than anticipated
  from biosimilar products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Even if we are successful in achieving regulatory
  approval to commercialize a product candidate faster than our competitors, our product candidates may face competition from biosimilar
  products. In the United&nbsp;States, our product candidates are regulated by the FDA as biologic products and we intend to seek approval
  for these product candidates pursuant to the BLA pathway. The Biologics Price Competition and Innovation Act&nbsp;of&nbsp;2009, or BPCIA,
  created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway
  establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar
  as &ldquo;interchangeable&rdquo; based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar
  product cannot be approved by the FDA until 12&nbsp;years after the original branded product was approved under a BLA.&nbsp;The law is
  complex and is still being interpreted and implemented by the FDA.&nbsp;As a result, its ultimate impact, implementation, and meaning
  are subject to uncertainty.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There is a risk that any exclusivity we may be
  afforded if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action,
  the results of recent litigation, or otherwise, or that the FDA will not consider our product candidates to be reference products for
  competing products, potentially creating the opportunity for generic or biosimilar competition sooner than anticipated. Moreover, the
  extent to which a biosimilar product, once approved, will be substituted for any one of our reference products in a way that is similar
  to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory
  factors that are still developing. In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA
  after completing its own preclinical studies and clinical trials. In such cases, any exclusivity to which we may be eligible under the
  BPCIA would not prevent the competitor from marketing its product as soon as it is approved.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, critics of the 12-year exclusivity
  period in the biosimilar pathway law will likely continue to seek to shorten the data exclusivity period and/or to encourage the FDA to
  interpret narrowly the law&rsquo;s provisions regarding which new products receive data exclusivity. In December&nbsp;2019, the US agreed
  to remove from the United&nbsp;States-Mexico-Canada Agreement a requirement for at least 10&nbsp;years of data exclusivity for biologic
  products. Also, the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference
  product&rsquo;s original 12-year exclusivity period (a concept known in the generic drug context as &ldquo;umbrella exclusivity&rdquo;).
  If the FDA were to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the
  exclusivity period, this could expose us to biosimilar competition at an earlier time. There also have been, and may continue to be, legislative
  and regulatory efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization,
  including efforts to lower standards for demonstrating biosimilarity or interchangeability, limit patents that may be litigated and/or
  patent settlements and implement preferential reimbursement policies for biosimilars.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If competitors are able to obtain marketing approval
  for biosimilars referencing our product candidates, if approved, such products may become subject to competition from such biosimilars,
  with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete
  with us in each indication for which our product candidates may have received approval.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our primary competitors have significantly greater resources
  and experience than we do, which may make it difficult for us to successfully develop our vaccine candidates, or may result in others
  discovering, developing or commercializing products before or more successfully than us.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The vaccine market is intensely competitive and
  is dominated by a small number of multinational, globally established pharmaceutical corporations with significant resources; Pfizer,
  Merck, GlaxoSmithKline and Sanofi together control approximately 75% of the global vaccine market. We may also face competition from many
  different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private
  research institutions. For example, Sanofi and SK Chemicals have partnered to develop a PCV, and Affinivax and Astellas have partnered
  to develop an affinity-bound pneumococcal vaccine.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Vaccine candidates that we successfully develop
  and commercialize may compete with existing vaccines and new vaccines that may become available in the future. Many of our competitors
  have substantially greater financial, lobbying, technical, human and other resources than we do and may be better equipped to develop,
  manufacture and market technologically superior vaccines, including the potential that our competitors may develop chemical processes
  or utilize novel technologies for developing vaccines that may be superior to those we employ. In addition, many of these competitors
  have significantly greater experience than we have in undertaking preclinical testing and clinical trials of new products and in obtaining
  regulatory approvals, including for many vaccine franchises. Accordingly, our competitors may succeed in obtaining FDA approval or a preferred
  recommendation for their products. For example, Prevnar 13 obtained FDA approval for the prevention of invasive pneumococcal disease,
  or IPD, in infants based on non-inferior IgG antibody responses relative to Prevnar, using the surrogate immune endpoints established
  by the prior Prevnar field efficacy study. Pfizer is currently implementing a similar approach to development of its 20-valent PCV vaccine
  candidate, and may have a more efficient path to regulatory approval given Pfizer&rsquo;s and the FDA&rsquo;s previous experience with
  Prevnar 13.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of our competitors have established distribution
  channels for the commercialization of their vaccine products, whereas we have no such established channels or capabilities. In addition,
  many competitors have greater name recognition, more extensive collaborative relationships or the ability to leverage a broader vaccine
  portfolio. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize vaccines that are safer,
  more effective, more convenient, less expensive or with a more favorable label than any vaccine candidates that we may develop.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a result of these factors, our competitors
  may obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine
  candidates. Our competitors may also develop vaccines that are safer, more effective, more widely accepted or less expensive than ours,
  and may also be more successful than we are in manufacturing and marketing their products. These advantages could render our vaccine candidates
  obsolete or non-competitive before we can recover the costs of such vaccine candidates&rsquo; development and commercialization.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Mergers and acquisitions in the pharmaceutical
  and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and
  early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established
  companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel,
  establishing clinical trial sites and subject enrollment for clinical trials, as well as in acquiring technologies complementary to, or
  necessary for, our programs.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Product liability lawsuits against us could cause us to incur
  substantial liabilities and to limit commercialization of any products that we may develop.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We face an inherent risk of product liability
  exposure related to the testing of our current product candidates or future product candidates in human clinical trials and will face
  an even greater risk if we commercially sell any products that we may develop. Product liability claims may be brought against us by subjects
  enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product. If we cannot successfully
  defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial liabilities. Regardless
  of merit or eventual outcome, liability claims may result in:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">decreased demand for any product candidates or products that we may develop;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">termination of clinical trial sites or entire clinical trial programs;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">injury to our reputation and significant negative media attention;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">withdrawal of clinical trial participants;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">significant costs to defend the related litigation;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">substantial monetary awards to trial subjects or patients;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">loss of revenue;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">diversion of management and scientific resources from our business operations; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the inability to commercialize any products that we may develop.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Prior to engaging in future clinical trials, we
  intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate
  to provide us with insurance coverage for foreseeable risks; however, we may be unable to obtain such coverage at a reasonable cost, if
  at all. If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable cost or
  in an amount adequate to satisfy any liability that may arise and such insurance may not be adequate to cover all liabilities that we
  may incur. Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain
  regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability
  insurance for any products that receive regulatory approval. Large judgments have been awarded in class&nbsp;action lawsuits based on
  drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly if
  judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may engage in acquisitions that could disrupt our business,
  cause dilution to our stockholders or reduce our financial resources.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the future, we may enter into transactions
  to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions
  on favorable terms, or at all. Any acquisitions we make may fail to strengthen our competitive position and these transactions may be
  viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or
  other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.
  We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
  may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
  into our existing business in an effective, timely and non-disruptive manner. Acquisitions may also divert management attention from&nbsp;day-to-day
  responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing
  or size of future acquisitions or the effect that any such transactions might have on our operating results.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Security threats to our information technology infrastructure
  and/or our physical buildings could expose us to liability and damage our reputation and business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is essential to our business strategy that
  our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners
  to be secure. Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security
  threats. We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products
  and services, misappropriate our or our customers&rsquo; and partners&rsquo; proprietary information, which may include personally identifiable
  information, or cause interruptions of our internal systems and services. Despite security measures, we also cannot guarantee security
  of our physical buildings. Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network
  infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that are affected,
  and expose us to financial liability.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, there are a number of state, federal
  and international laws protecting the privacy and security of health information and personal data. For example, the Health Insurance
  Portability and Accountability Act&nbsp;of&nbsp;1996, or HIPAA, imposes limitations on the use and disclosure of an individual&rsquo;s
  healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities,
  and also grants individuals rights with respect to their health information. HIPAA also imposes compliance obligations and corresponding
  penalties&nbsp;for&nbsp;non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.
  As part of the American Recovery and Reinvestment Act&nbsp;of&nbsp;2009, or ARRA, the privacy and security provisions of HIPAA were amended.
  ARRA also made significant increases in the penalties for improper use or disclosure of an individual&rsquo;s health information under
  HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently by the final omnibus rule adopted
  in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been inappropriately
  accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national
  media. Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance
  with encryption or other standards developed by the U.S.&nbsp;Department of Health and Human Services. Most states have laws requiring
  notification of affected individuals and/or state regulators in the event of a breach of personal information, which is a broader class
  of information than the health information protected by HIPAA.&nbsp;Many state laws impose significant data security requirements, such
  as encryption or mandatory contractual terms, to ensure ongoing protection of personal information. Activities outside of the U.S.&nbsp;implicate
  local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement&nbsp;for&nbsp;non-compliance.&nbsp;We&nbsp;may
  be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws,
  to protect against security breaches and hackers or to alleviate problems caused by such breaches.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We will need to grow the size of our organization in the future,
  and we may experience difficulties in managing this growth.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">As of May 20, 2022, we had 5 full-time and 7 subcontracted
  employees. We will need to grow the size of our organization in order to support our continued development and potential commercialization
  of our product candidates. As our development and commercialization plans and strategies continue to develop, our need for additional
  managerial, operational, manufacturing, sales, marketing, financial and other resources may increase. Our management, personnel and systems
  currently in place may not be adequate to support this future growth. Future growth would impose significant added responsibilities on
  members of management, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">managing our clinical trials effectively;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">identifying, recruiting, maintaining, motivating and integrating additional employees;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>improving our managerial, development, operational, information technology, and finance systems; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">expanding our facilities.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our operations expand, we will also need to
  manage additional relationships with various strategic partners, suppliers and other third parties. Our future financial performance and
  our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future
  growth effectively, as well as our ability to develop a sales and marketing force when appropriate. To that end, we must be able to manage
  our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,
  research and development, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks
  could prevent us from successfully growing our company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our future success depends on our ability to retain our executive
  officers and to attract, retain and motivate qualified personnel.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are highly dependent upon our personnel, including
  Joseph Hernandez, our Chief Executive Officer and members of our board of directors. The loss of Mr.&nbsp;Hernandez&rsquo;s services could
  impede the achievement of our research, development and commercialization objectives. We have not obtained, do not own, nor are we the
  beneficiary of, key-person&nbsp;life insurance. Our future growth and success depend on our ability to recruit, retain, manage and motivate
  our employees. The loss of any member of our senior management team or the inability to hire or retain experienced management personnel
  could compromise our ability to execute our business plan and harm our operating results. Because of the specialized scientific and managerial
  nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.
  The competition for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract
  and retain qualified personnel necessary for the development of our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Chief Executive Officer, Joseph Hernandez, and our Chief
  Financial Officer, Jon Garfield, also hold certain management positions and directorships of other companies and may allocate their time
  to such other businesses, thereby causing conflicts of interest in their determination as to how much time to devote to our affairs. This
  could have a negative impact on our ability to implement our plan of operation.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Chief Executive Officer, Joseph Hernandez
  is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest
  in allocating his time between our operations and his other businesses. Pursuant to Mr.&nbsp;Hernandez&rsquo;s employment agreement, Mr.&nbsp;Hernandez
  shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business activities.
  Subject to our Board&rsquo;s prior approval, Mr.&nbsp;Hernandez may serve as an officer, stakeholder, or member of the board of directors
  or advisory board (or the equivalent in the case of a non-corporate entity) of non-competing for-profit businesses and charitable organizations,
  provided, however, that such activities do not materially interfere, individually or in the aggregate, with the performance of his duties
  and responsibilities to Blue Water Vaccines Inc. Accordingly, although Mr.&nbsp;Hernandez&rsquo;s primary occupation is his service to
  Blue Water Vaccines Inc., he also holds certain management positions and directorships of other companies, and may allocate his time to
  such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, our Chief Financial Officer, Jon
  Garfield, is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict
  of interest in allocating his time between our operations and his other businesses. Pursuant to Mr.&nbsp;Garfield&rsquo;s employment agreement,
  Mr.&nbsp;Garfield shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business
  activities, subject to the restrictions imposed on Mr.&nbsp;Hernandez as described above. Accordingly, Mr.&nbsp;Garfield holds certain
  management positions and directorships of other companies, and may allocate his time to such other businesses, thereby causing conflicts
  of interest in his determination as to how much time to devote to our affairs</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Each of Messrs. Hernandez and Garfield may also
  have competitive fiduciary obligations and pecuniary interests relating to their other business ventures that conflict with our interests.
  Each of Messrs. Hernandez and Garfield&rsquo;s employment agreement contains certain restrictive covenants while they are employed at
  Blue Water Vaccines Inc. These restrictive covenants, generally, restrict Messrs. Hernandez and Garfield from engaging in any other business
  or occupation that (x)&nbsp;conflicts with the interests of the Company, (y)&nbsp;interferes with the proper and efficient performance
  of his duties for the Company, or (z)&nbsp;interferes with his exercise of judgment in the Company&rsquo;s best interests. Messrs. Hernandez
  and Garfield are further subject to general restrictions regarding the solicitation of employees, certain customers, as well as the use
  or disclosure of any confidential information, of the business of Blue Water Vaccines Inc. Notwithstanding the foregoing, to the extent
  that these additional activities may have a conflict between their interests and ours, this could have a negative impact on our ability
  to implement our plan of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Certain significant personnel may allocate their time to other
  businesses, which may cause conflicts of interest in their determination as to how much time to devote to our affairs and potentially
  competitive fiduciary and pecuniary interests that conflict with our interests.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our executive officers are supported by Ronald
  Cobb, Brian Price and Andrew Skibo, who provide valuable technical and strategic capabilities to us. They are not currently required to
  commit their full time to our affairs. As such, they may allocate their time to other businesses. From time to time, those other commitments
  may limit the nature of services that Messrs. Cobb, Price and Skibo provide to our Company, for instance, where such activities may involve
  overlapping industries and products. If these individuals&rsquo; other business affairs require them to devote substantial amounts of
  time to such affairs in excess of their current commitment levels, it could limit their ability to devote time or resources to our affairs,
  which may have a negative impact on our ability to complete our plan of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Members of our management team and board of directors have significant
  experience as founders, board members, officers or executives of other companies. As a result, certain of those persons have been and
  may become involved in proceedings, investigations and litigation relating to the business affairs of the companies with which they were,
  are, or may in the future be, affiliated. This may have an adverse effect on us, could damage our reputation and business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">During the course of their careers, members of
  our management team and board of directors have had significant experience as founders, board members, officers or executives of other
  companies. As a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become,
  involved in litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered
  into by such companies. Any such litigation, investigations or other proceedings may divert our management team&rsquo;s and board&rsquo;s
  attention and resources away from our affairs and may negatively affect our reputation and our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Inadequate funding for the FDA, the SEC and other government
  agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being
  developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which
  the operation of our business may rely, which could negatively impact our business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The ability of the FDA to review and approve new
  products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel
  and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
  in recent&nbsp;years as a result. In addition, government funding of the SEC and other government agencies on which our operations may
  rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and
  unpredictable.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Disruptions at the FDA and other agencies may
  also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect
  our business. For example, over the last several&nbsp;years, including beginning on December&nbsp;22, 2018, the U.S.&nbsp;government has
  shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other
  government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability
  of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further,
  in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary
  capital in order to properly capitalize and continue our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be adversely affected by natural disasters, pandemics
  and other catastrophic events, some possible related to the increasing effects of climate change, and by man-made problems such as terrorism
  and acts of war, that could disrupt our business operations and our business continuity and disaster recovery plans may not adequately
  protect us from a serious disaster.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are vulnerable to the increasing impact of
  climate change and other natural disasters. If a disaster, power outage or other event occurred that prevented us from using all or a
  significant portion of our headquarters, that damaged critical infrastructure, such as enterprise financial systems, manufacturing resource
  planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for
  us to continue our business for a substantial period of time. Our contract manufacturers&rsquo; and suppliers&rsquo; facilities are located
  in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes, fires, explosions or large-scale
  accidents or power outages, and other public health emergencies could severely disrupt our operations and have a material adverse effect
  on our business, financial condition, operating results and prospects. For example, the recent COVID-19 pandemic may cause significant
  disruption to our business operations, the operations of our third-party contractors and suppliers and the operations of our clinical
  trials, including as a result of significant restrictions or bans on travel into and within the geographic areas in which our manufacturers
  product our product candidates or where we conduct our clinical trials. A public health emergency could also affect the operations of
  the FDA and other regulatory or public health authorities, resulting in delays to meetings related to planned or completed clinical trials
  and ultimately of reviews and approvals of our product candidates. Such disruption could impede, delay, limit or prevent our employees
  and third-party contractors from beginning or continuing research and development or clinical trial-related activities, which may impede,
  delay, limit or prevent initiation or completion of our ongoing clinical trials and preclinical research and ultimately lead to the delay
  or denial of regulatory approval of our product candidates, which could seriously harm our operations and financial condition.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our employees, independent contractors, principal investigators,
  consultants, vendors and clinical research organizations, or CROs, may engage in misconduct or other improper activities, including noncompliance
  with regulatory standards and requirements.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exposed to the risk that our employees,
  independent contractors, principal investigators, consultants, vendors and CROs may engage in fraudulent or other illegal activity. Misconduct
  by these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates: laws or regulations,
  including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities;
  manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete
  and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare
  industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may
  restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing
  and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve
  the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result
  in regulatory sanctions or other actions or lawsuits stemming from a failure to comply with such laws or regulations, and serious harm
  to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts
  and require certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted against us, we may
  have to terminate employees or others involved and the impact of such termination can result in our experiencing delays and additional
  costs associated with replacing the services being provided. If we are not successful in defending ourselves or asserting our rights,
  those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,
  damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment,
  contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could
  adversely affect our ability to operate our business and our operating results.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Macroeconomic pressures in the markets in which we operate, including,
  but not limited to, the effect of the COVID-19 pandemic and the current conflict between Ukraine and Russia may alter the ways in which
  we conduct our business operations and manage our financial capacities.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To varying degrees, the ways in which we conduct
  our business operations and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly
  involved in or providing services related to the drug and biological product development. For example, real GDP growth, business and investor
  confidence, the COVID-19 pandemic, the conflict between Ukraine and Russia, inflation, employment levels, oil prices, interest rates,
  tax rates, availability of consumer and business financing, housing market conditions, foreign currency exchange rate fluctuations, costs
  for items such as fuel and food and other macroeconomic trends can adversely affect not only our decisions and ability to engage in research
  and development and clinical trials, but also those of our management, employees, third-party contractors, manufacturers and suppliers,
  competitors, stockholders and regulatory authorities. In addition, geopolitical issues around the world and how our markets are positioned
  can also impact the macroeconomic conditions and could have a material adverse impact on our financial results.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Economic uncertainty may adversely affect our access to capital,
  cost of capital and ability to execute our business plan as scheduled.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Generally, worldwide economic conditions remain
  uncertain. Access to capital markets is critical to our ability to operate. Traditionally, biotechnology companies have funded their research
  and development expenditures through raising capital in the equity markets. Declines and uncertainties in these markets in the past have
  severely restricted raising new capital and have affected companies&rsquo; ability to continue to expand or fund existing research and
  development efforts. We require significant capital for research and development for our vaccine candidates and clinical trials. The general
  economic and capital market conditions, both in the U.S.&nbsp;and worldwide, have been volatile in the past and at times have adversely
  affected our access to capital and increased the cost of capital. There is no certainty that the capital and credit markets will be available
  to raise additional capital on favorable terms. If economic conditions become worse, our future cost of equity or debt capital and access
  to the capital markets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our
  ability to execute our business plan as scheduled would be compromised. Moreover, we rely and intend to rely on third-parties, including
  clinical research organizations, contract manufacturing organizations and other important vendors and consultants. Global economic conditions
  may result in a disruption or delay in the performance of our third-party contractors and suppliers. If such third-parties are unable
  to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.<B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be subject to legal proceedings that may adversely affect
  our Securities.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">On April 15, 2022, the Company received a demand
  letter (the &ldquo;Demand Letter&rdquo;) from Boustead Securities, LLC (&ldquo;Boustead&rdquo;), the Company&rsquo;s underwriter in its
  initial public offering. The Demand Letter alleges that the Company breached the underwriting agreement (the &ldquo;Underwriting Agreement&rdquo;)
  entered into between Boustead and the Company, dated February 17, 2022 in connection with the Company&rsquo;s IPO. The Demand Letter alleges
  that, by engaging Wainwright as placement agent in the Private Placement, the Company breached the right of first refusal to act as placement
  agent granted to Boustead under the Underwriting Agreement and, as a result of selling securities in the Private Placement, breached the
  12-month lock-up obligation following the consummation of the initial public offering under the Underwriting Agreement. The Demand Letter
  requested that the Company rescind the Private Placement. The Company has not responded to the Demand Letter and no legal action has been
  brought by Boustead to date. There can be no assurance as to whether any litigation will be commenced against the Company with respect
  to the demand letter or that, if any such litigation is commenced, the Company will not incur material losses due to damages, penalties,
  costs and/or expenses as a result of such litigation or that any such losses will not have a material impact on the Company&rsquo;s financial
  condition or results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Our Intellectual Property</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>It is difficult and costly to protect our proprietary rights,
  and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could
  compete against us more directly, which would harm our business, possibly materially.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our commercial success will depend in part on
  obtaining and maintaining patent protection and trade secret protection of our current product candidates and future product candidates,
  the processes used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party&nbsp;challenges.
  Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent upon
  the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The patent positions of biotechnology and pharmaceutical
  companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
  No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S.&nbsp;or in foreign
  jurisdictions outside of the U.S.&nbsp;Changes in either the patent laws or interpretations of patent laws in the U.S.&nbsp;and other
  countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be enforced
  in the patents that may be issued from the applications we currently license or may in the future own or license from third parties. Further,
  if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates
  or technology could be adversely affected.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Others may file patent applications covering products
  and technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent
  application owned by a third party will not have priority over patent applications filed or in-licensed&nbsp;by us, or that we or our
  licensors will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings
  before U.S.&nbsp;or non-U.S.&nbsp;patent offices. Such proceedings are also expensive and time consuming.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The degree of future protection for our proprietary
  rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
  or keep our competitive advantage. For example:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>others may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the patents of others may have an adverse effect on our business.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are dependent on licensed intellectual property. If we were
  to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates,
  if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product
  candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license
  rights that are important to our business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We do not currently own any patents, and we are
  heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important to our
  business and we may need or choose to enter into additional license agreements in the future. Our existing license agreements impose,
  and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations,
  payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, or we
  are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products
  covered by the license. Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to
  abide by the terms of the license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable
  to enter into necessary licenses on acceptable terms.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Licensing of intellectual property is of critical
  importance to our business and involves complex legal, business and scientific issues. Disputes may arise between us and our licensors
  regarding intellectual property subject to a license agreement, including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the scope of rights granted under the license agreement and other interpretation-related issues;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">our right to sublicense patent and other rights to third parties;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">our obligation to pursue or license others to pursue development of indications we are not currently pursuing;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">our right to transfer or assign the license; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">the effects of termination.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If disputes over intellectual property that we
  have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully
  develop and commercialize the affected product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have entered into several licenses to support
  our various programs. Termination of any of these license agreements would have a material adverse impact on our ability to develop and
  commercialize derived products under each respective agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may enter into additional licenses to third-party
  intellectual property that are necessary or useful to our business. Our current licenses and any future licenses that we may enter into
  impose various royalty payment, milestone, and other obligations on us. Under some license agreements, we may not control prosecution
  of the licensed intellectual property, or may not have the first right to enforce the intellectual property. In those cases, we may not
  be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance
  fees. If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have
  breached our license agreement, and may accordingly seek to terminate our license. Termination of any of our current or future licenses
  could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to
  develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business
  prospects. Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual
  property and information related to the product candidate being developed under the license, such as regulatory information.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The agreements under which we license intellectual
  property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple
  interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope
  of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations
  under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations
  and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current
  licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product
  candidates</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, if our licensors fail to abide by
  the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are
  found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.
  Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject
  to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor&rsquo;s rights.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Similarly, if we are unable to successfully obtain
  rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have
  to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and
  investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results
  of operations and prospects could suffer.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Some of the intellectual property covered by our licenses concerns
  patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications
  will result in granted patents, nor can we predict how long it will take for such patents to be granted.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of intellectual property covered by our licenses
  concerns certain, specified patent rights (including patent applications, provisional patent applications and PCT patent applications).
  While in some instances, the licensors have agreed to assume responsibility for the preparation, filing, prosecution and maintenance of
  patent applications covered by the licensed patent rights, we cannot be certain as to when or if final patents will be issued for those
  patent applications covered by the licensed patent rights. However, the licensors may not successfully prosecute certain patent applications,
  the prosecution of which they control, under which we are only a licensee and on which our business substantially depends. Even if patents
  issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability
  challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may
  fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, it is possible that the licensed pending
  patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide
  a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.
  Further, it is possible that, for any of the patents that may be granted in the future, others will design around the licensed patent
  rights or identify methods for preventing or treating infectious diseases that do not concern the rights covered by our licenses. Further,
  we cannot assure investors that other parties will not challenge any patents granted to the licensors or that courts or regulatory agencies
  will hold licensor&rsquo;s patents to be valid or enforceable. We cannot guarantee investors that, if required to defend the covered patents,
  we will have the funds to or be successful in defending challenges made against the licensed patents and patent applications. Any successful
  third-party challenge to the licensed patents could result in the unenforceability or invalidity of such patents, or to such patents being
  interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological or competitive
  advantage over our competitors may be diminished because of these uncertainties.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Even if patents are issued based on patent applications to which
  we have been granted a license, because the patent positions of pharmaceutical and biotechnology products are complex and uncertain, we
  cannot predict the scope and extent of patent protection for our product candidates.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any patents that may be issued based on patent
  applications that we have been granted licenses to will not ensure sufficient protection with respect to our activities for a number of
  reasons, including without limitation the following:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>any issued patents may not be broad or strong enough to prevent competition from other vaccine products including identical or similar products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>if patents are not issued or if issued patents expire, there would be no protections against competitors making generic equivalents;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>there may be other patents existing, now or in the future, in the patent landscape for our product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
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    <TR STYLE="vertical-align: top">
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      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>if patents that we have been granted licenses to are challenged, a court could determine that they are not valid or enforceable;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
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      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a court could determine that a competitor&rsquo;s technology or product does not infringe patents that we have been granted licenses to;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
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      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>patents to which we have been granted licenses could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -0.25in">&nbsp;</P>
  
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      <TD>if we encounter delays in our development or clinical trials, the period of time during which we could market our products under patent protection would be reduced.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Obtaining and maintaining patent protection depends on compliance
  with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection
  could be reduced or eliminated for noncompliance with these requirements.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Periodic maintenance fees on any issued patent
  are due to be paid to the United&nbsp;States Patent and Trademark Office (USPTO) and foreign Intellectual Property Offices in several
  stages over the term of the patent. Maintenance fees are also due for pending patent applications in some countries. The USPTO and various
  foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
  during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means
  in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent
  or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that
  could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to office actions
  within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our
  competitors might be able to enter the market, which would have a material adverse effect on our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The life of patent protection is limited, and third parties could
  develop and commercialize products and technologies similar or identical to ours and compete directly with us after the patent licensed
  to us expires, which could materially and adversely affect our ability to commercialize our products and technologies.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The life of a patent and the protection it affords
  is limited. For example, in the United&nbsp;States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
  20&nbsp;years from its earliest U.S.&nbsp;non-provisional filing date. In Europe, the expiration of an invention patent is 20&nbsp;years
  from its filing date. Even if we successfully obtain patent protection for an approved vaccine candidate, it may face competition from
  biosimilar medications. Manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying
  our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual
  property rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materially
  adversely affect any potential sales of that product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Given the amount of time required for the development,
  testing and regulatory review of new vaccine candidates, patents protecting such vaccine candidates might expire before or shortly after
  such vaccine candidates are commercialized. As a result, the patents and patent applications licensed to us may not provide us with sufficient
  rights to exclude others from commercializing products similar or identical to ours. Even if we believe that the patents involved are
  eligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including the
  FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions
  are available, and such authorities may refuse to grant extensions to such patents, or may grant more limited extensions than requested.
  For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop,
  one or more of the U.S.&nbsp;patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition
  and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of
  up to five&nbsp;years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend
  the remaining term of a patent beyond a total of 14&nbsp;years from the date of product approval, only one patent may be extended and
  only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may
  not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process,
  failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy
  applicable requirements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Moreover, the applicable time period or the scope
  of patent protection afforded could be less than requested. If we are unable to obtain patent term extension or term of any such extension
  is less than requested, our competitors may obtain approval of competing products following our patent expiration, and our business could
  be harmed. Changes in either the patent laws or interpretation of the patent laws in the United&nbsp;States and other countries may diminish
  the value of our patents or narrow the scope of our patent protection.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The patents and pending patent applications licensed
  to us for our product candidates are expected to expire on various dates. Upon the expiration, we will not be able to assert such licensed
  patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations
  and prospects.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may need to license intellectual property from third parties,
  and such licenses may not be available or may not be available on commercially reasonable terms or at all.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">There may be intellectual property rights existing
  now, or in the future, relevant to our product candidates that we seek to commercialize or develop, if any, that may affect our ability
  to commercialize such product candidates. Although the Company is not aware of any such intellectual property rights, a third-party may
  hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product
  candidates. Even if all our main product candidates are covered by patents, it may be necessary for us to use the patented or proprietary
  technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these
  third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable
  contractual terms. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates,
  or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical
  or commercial basis. If we are unable to do so, our business could be harmed.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The licensing or acquisition of third-party intellectual
  property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party
  intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage
  over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies
  that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third
  party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable
  to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights
  we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on
  our business, financial condition, results of operations, and prospects.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may infringe the intellectual property rights of others, which
  may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product
  candidates.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our success will depend in part on our ability
  to operate without infringing the proprietary rights of third parties. We are not aware of any third party proprietary rights that our
  planned products will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages
  of development. We thus cannot guarantee that our product candidates, or manufacture or use of our product candidates, will not infringe
  third-party&nbsp;patents. Furthermore, a third party may claim that we are using inventions covered by the third party&rsquo;s patent
  rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.
  These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel.
  Some of these third parties may be better capitalized and have more resources than us. There is a risk that a court would decide that
  we are infringing the third party&rsquo;s patents and would order us to stop the activities covered by the patents. In that event, we
  may not have a viable way around the patent and may need to halt commercialization of our product candidates. In addition, there is a
  risk that a court will order us to pay the other party damages for having violated the other party&rsquo;s patents. In addition, we may
  be obligated to indemnify our licensors and collaborators against certain intellectual property infringement claims brought by third&nbsp;parties,
  which could require us to expend additional resources. The pharmaceutical and biotechnology industries have produced a proliferation of
  patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of
  use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we are sued for patent infringement, we would
  need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the
  patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity
  requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are
  successful in these proceedings, we may incur substantial costs and diversion of management&rsquo;s time and attention in pursuing these
  proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may
  be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court.
  Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.
  In addition, if we do not obtain a license, develop or obtain non-infringing&nbsp;technology, fail to defend an infringement action successfully
  or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product
  candidates to market and be precluded from manufacturing or selling our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of our competitors may be able to sustain
  the costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because
  they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation
  could have a material adverse effect on our ability to raise the funds necessary to continue our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may become involved in lawsuits to protect or enforce our
  intellectual property, which could be expensive, time consuming and unsuccessful.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition to the possibility of litigation relating
  to infringement claims asserted against it, we may become a party to other patent litigation and other proceedings, including <I>inter
  partes</I> review proceedings, post-grant review proceedings, derivation proceedings declared by the USPTO and similar proceedings in
  foreign countries, regarding intellectual property rights with respect to our current or future technologies or product candidates or
  products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our
  competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially
  greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties resulting
  from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Competitors may infringe or otherwise violate
  our intellectual property, including patents that may issue to or be licensed by us. As a result, we may be required to file claims in
  an effort to stop third-party infringement or unauthorized use. Any such claims could provoke these parties to assert counterclaims against
  us, including claims alleging that we infringe their patents or other intellectual property rights, and/or that any of our intellectual
  property, including licensed intellectual property, is invalid and/or unenforceable. This can be prohibitively expensive, particularly
  for a company of our size, and time-consuming, and even if we are successful, any award of monetary damages or other remedy we may receive
  may not be commercially valuable. In addition, in an infringement proceeding, a court may decide that our asserted intellectual property
  is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our intellectual
  property does not cover its technology. An adverse determination in any litigation or defense proceedings could put our intellectual property
  at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If the breadth or strength of our patent or other
  intellectual property rights is compromised or threatened, it could allow third parties to exploit and, in particular, commercialize our
  technology or products or result in our inability to exploit and/or commercialize our technology and products without infringing third-party
  intellectual property rights. Further, third parties may be dissuaded from collaborating with us.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Interference or derivation proceedings brought
  by the USPTO or its foreign counterparts may be necessary to determine the priority of inventions with respect to our patent applications,
  and we may also become involved in other proceedings, such as re-examination proceedings, before the USPTO or its foreign counterparts.
  Due to the substantial competition in the pharmaceutical space, the number of such proceedings may increase. This could delay the prosecution
  of our pending patent applications or impact the validity and enforceability of any future patents that we may obtain. In addition, any
  such litigation, submission or proceeding may be resolved adversely to us and, even if successful, may result in substantial costs and
  distraction to our management.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we are not able to adequately prevent disclosure of trade
  secrets and other proprietary information, the value of our technology and product could be significantly diminished.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We also rely on trade secrets to protect our proprietary
  technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult
  to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored
  researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent
  disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential
  information. In addition, others may independently discover our trade secrets and proprietary information. For example, the FDA, as part
  of its transparency initiative, is currently considering whether to make additional information publicly available on a routine basis,
  including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time
  how the FDA&rsquo;s disclosure policies may change in the future, if at all. Costly and time-consuming&nbsp;litigation could be necessary
  to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely
  affect our competitive business position.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be subject to claims that our employees or consultants
  have wrongfully used or disclosed alleged trade secrets.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As is common in the biotechnology and pharmaceutical
  industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors
  or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how&nbsp;of
  others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used
  or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these
  claims. If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property
  rights or personnel, which could adversely impact our business. Even if we are successful in defending against these claims, litigation
  could result in substantial costs and be a distraction to management.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our intellectual property may not be sufficient to protect our
  product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may be subject to competition despite the existence
  of intellectual property we license or may in the future own. We can give no assurances that our intellectual property claims will be
  sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive products.
  The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and
  financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third
  parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization
  of our product candidates or future product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We may elect to sue a third party, or otherwise
  make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or
  other intellectual property rights that we either own or license from a third party. If we do not prevail in enforcing our intellectual
  property rights in this type of litigation, we may be subject to:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>paying monetary damages related to the legal expenses of the third party;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">A third party may also challenge the validity,
  enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope
  or claims of or invalidate patents that are integral to our product candidates in the future. There can be no assurance that we will be
  able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and
  the high costs associated with intellectual property litigation, amongst other factors.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Intellectual property rights may be less extensive
  and enforcement more difficult in jurisdictions outside of the U.S.&nbsp;Therefore, we may not be able to protect our intellectual property
  and third parties may be able to market competitive products that may use some or all of our intellectual property.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Changes to patent law, including the Leahy-Smith&nbsp;America
  Invests Act&nbsp;of&nbsp;2011 and the Patent Reform Act&nbsp;of&nbsp;2009 and other future article of legislation, may substantially change
  the regulations and procedures surrounding patent applications, issuance of patents and prosecution of patents. We can give no assurances
  that the patents of our licensor can be defended or will protect us against future intellectual property challenges, particularly as they
  pertain to changes in patent law and future patent law interpretations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Healthcare Compliance and Other Regulations</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we fail to comply with healthcare regulations, we could face
  substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be
  adversely affected.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We could be subject to healthcare fraud and abuse
  laws and patient privacy laws of both the federal government and the states in which we conduct our business. The laws include:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
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      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>HIPAA which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products&nbsp;for&nbsp;off-label&nbsp;use&nbsp;and regulates the distribution of drug samples; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
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    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If our operations are found to be in violation
  of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and
  criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment
  or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Although compliance
  programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
  Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal
  expenses and divert management&rsquo;s attention from the operation of our business. Moreover, achieving and sustaining compliance with
  applicable federal and state privacy, security and fraud laws may prove costly.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Healthcare reform in the United&nbsp;States has been implemented
  in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry.
  Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In the United&nbsp;States, there have been, and
  continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future
  results of pharmaceutical manufactures&rsquo; operations. In particular, there have been and continue to be a number of initiatives at
  the federal and state levels that seek to reduce healthcare costs. For example, the Affordable Care Act, or the ACA, which was originally
  enacted in March&nbsp;2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both
  governmental and private insurers. Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry
  are the following:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>implementation of the federal physician payment transparency requirements, sometimes referred to as the &ldquo;Physician Payments Sunshine Act&rdquo;;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a licensure framework for&nbsp;follow-on&nbsp;biologic products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>establishment of a Center for Medicare Innovation at the Centers for Medicare&nbsp;&amp; Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>extension of manufacturers&rsquo; Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers&rsquo; Medicaid rebate liability;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a new Medicare Part&nbsp;D coverage gap discount program, in which manufacturers must agree to offer 50%&nbsp;point-of-sale&nbsp;discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer&rsquo;s outpatient drugs to be covered under Medicare Part&nbsp;D; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>expansion of the entities eligible for discounts under the Public Health program.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Some of the provisions of the ACA have yet to
  be implemented, and there have been legal and political challenges to certain aspects of the ACA.&nbsp;The former Trump administration
  issued certain executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA.&nbsp;Concurrently,
  Congress considered legislation that would repeal or repeal and replace all or part of the ACA.&nbsp;While Congress has not passed repeal
  legislation, the Tax Cuts and Jobs Act&nbsp;of&nbsp;2017 included a provision repealing, effective January&nbsp;1, 2019, the&nbsp;tax-based&nbsp;shared
  responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a
  year that is commonly referred to as the &ldquo;individual mandate.&rdquo; Congress may consider other legislation to repeal or replace
  elements of the ACA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Many of the details regarding the implementation
  of the ACA are yet to be determined, and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains
  unclear. In particular, there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA.&nbsp;This uncertainty
  is heightened by President Biden&rsquo;s January&nbsp;28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act,
  which indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump
  administration.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The FDA has issued several guidance documents,
  but no implementing regulations, on biosimilars. A number of biosimilar applications have been approved over the past few&nbsp;years.
  The regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical
  manufacturers conduct their business and may require changes to current strategies. A biosimilar is a biological product that is highly
  similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically
  meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Individual states have become increasingly aggressive
  in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price
  or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency
  measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by
  third-party payors or other restrictions could harm a pharmaceutical manufacturer&rsquo;s business, results of operations, financial condition
  and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
  what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could
  reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical manufacturer&rsquo;s
  business, results of operations, financial condition and prospects.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">It is also possible that President Biden will
  further reform the ACA and other federal programs in a manner that may impact our operations. For example, the Biden administration has
  indicated that a goal of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible
  and affordable. The potential increase in patients covered by government funded insurance may impact our pricing. Further, it is possible
  that the Biden administration may further increase the scrutiny on drug pricing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, given recent federal and state government
  initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely continue
  to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. For
  example, there have been several recent U.S.&nbsp;congressional inquiries and proposed federal and proposed and enacted state legislation
  designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient
  programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. Further,
  in July&nbsp;2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug
  products including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts
  for plans, pharmacies, and pharmaceutical benefit managers. No assurance can be given whether these orders will remain in effect under
  the&nbsp;Biden&nbsp;administration.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">While no one can predict the full outcome of any
  such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure
  to reduce prescription drug prices. This could harm a pharmaceutical manufacturer&rsquo;s ability to generate revenue. Increases in importation
  or&nbsp;re-importation&nbsp;of pharmaceutical products from foreign countries into the United&nbsp;States could put competitive pressure
  on a pharmaceutical manufacturer&rsquo;s ability to profitably price products, which, in turn, could adversely affect business, results
  of operations, financial condition and prospects. A pharmaceutical manufacturer might elect not to seek approval for or market products
  in foreign jurisdictions in order to minimize the risk of&nbsp;re-importation,&nbsp;which could also reduce the revenue generated from
  product sales. It is also possible that other legislative proposals having similar effects will be adopted.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Furthermore, regulatory authorities&rsquo; assessment
  of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as
  the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership. We cannot
  be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. For example,
  average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding
  levels and statutory, regulatory and policy changes.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our employees may engage in misconduct or other
  improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us
  and harm our reputation.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are exposed to the risk of employee fraud or
  other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory
  authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards
  we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established
  and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities
  to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result
  in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the
  precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in
  protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
  or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,
  those actions could have a significant impact on our business and results of operations, including the imposition of significant civil,
  criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare
  and Medicaid, and integrity oversight and reporting obligations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may rely on government funding and collaboration with government
  entities for our vaccine development, which adds uncertainty to our research and development efforts and may impose requirements that
  increase the costs of development, commercialization and production of any programs developed under those government-funded programs.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Because we anticipate the resources necessary to develop our vaccine
  product candidates will be substantial, we may explore funding and development collaboration opportunities with the U.S.&nbsp;government
  and its agencies. For example, we may apply for certain grant funding from BARDA, the NIH or other government agencies to further the
  research, development, manufacture, testing, and regulatory approval of our vaccine product candidates. We have no control or input over
  whether an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide
  investors with any assurances that we will receive such funding.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Contracts and grants funded by the U.S.&nbsp;government
  and its agencies, contain provisions that reflect the government&rsquo;s substantial rights and remedies, many of which are not typically
  found in commercial contracts, including powers of the government to:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>reduce or modify the government&rsquo;s obligations under such agreements without the consent of the other party;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>claim rights, including Intellectual Property rights, in products and data developed under such agreements;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>audit contract-related costs and fees, including allocated indirect costs;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>impose U.S.&nbsp;manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>suspend or debar the contractor or grantee from doing future business with the government;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>control and potentially prohibit the export of products;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>limit the government&rsquo;s financial liability to amounts appropriated by the U.S.&nbsp;Congress on a fiscal-year basis, thereby leaving some uncertainty about the future availability of funding for a program even after it has been funded for an initial period.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we received such grants or agreements, we may
  not have the right to prohibit the U.S.&nbsp;government from using certain technologies developed by us, and we may not be able to prohibit
  third-parties, including our competitors, from using those technologies in providing products and services to the U.S.&nbsp;government.
  Further, under such agreements we could be subject to obligations to and the rights of the U.S.&nbsp;government set forth in the Bayh-Dole
  Act&nbsp;of&nbsp;1980, meaning the U.S.&nbsp;government may have rights in certain inventions developed under these government-funded
  agreements, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
  In addition, the U.S.&nbsp;government could have the right to require us to grant exclusive, partially exclusive, or nonexclusive licenses
  to any of these inventions to a third party if it determines that: (i)&nbsp;adequate steps have not been taken to commercialize the invention;
  (ii)&nbsp;government action is necessary to meet public health or safety needs; or (iii)&nbsp;government action is necessary to meet requirements
  for public use under federal regulations, also referred to as &ldquo;march-in rights.&rdquo; Although the U.S.&nbsp;government&rsquo;s
  historic restraint with respect to these rights indicates they are unlikely to be used, any exercise of the march-in rights could harm
  our competitive position, business, financial condition, results of operations, and prospects. In the event we would be subject to the
  U.S.&nbsp;government&rsquo;s exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S.&nbsp;government
  in its sole discretion, which may be less than what we might be able to obtain in the open market.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Additionally, the U.S.&nbsp;government requires
  that any products embodying any invention generated through the use of U.S.&nbsp;government funding be manufactured substantially in the
  United&nbsp;States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable
  but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
  substantially in the United&nbsp;States or that under the circumstances domestic manufacture is not commercially feasible. This preference
  for U.S.&nbsp;manufacturers may limit our ability to contract with non-U.S.&nbsp;manufacturers for products covered by such intellectual
  property.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Although we may need to comply with some of these
  obligations, not all of the aforementioned obligations may be applicable to us unless and only to the extent that we receive a government
  grant, contract or other agreement. However, as an organization, we are relatively new to government contracting and new to the regulatory
  compliance obligations that such contracting entails. If we were to fail to maintain compliance with those obligations, we may be subject
  to potential liability and to termination of our contracts, which may have a materially adverse effect on our ability to develop our vaccine
  product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are subject to U.S.&nbsp;and certain foreign export and import
  controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations.&nbsp;Compliance with these legal
  standards could impair our ability to compete in domestic and international markets.&nbsp;We can face criminal liability and other serious
  consequences for violations, which can harm our business.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are subject to export control and import laws
  and regulations, including the U.S.&nbsp;Export Administration Regulations, U.S.&nbsp;Customs regulations, various economic and trade
  sanctions regulations administered by the U.S.&nbsp;Treasury Department&rsquo;s Office of Foreign Assets Controls, the U.S.&nbsp;Foreign
  Corrupt Practices Act&nbsp;of&nbsp;1977, as amended, the U.S.&nbsp;domestic bribery statute contained in 18 U.S.C. &sect; 201, the U.S.&nbsp;Travel
  Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct
  activities.&nbsp;Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other
  collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value
  to recipients in the public or private sector.&nbsp;We may engage third parties for clinical trials outside of the United&nbsp;States,
  to sell our products abroad once we enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations,
  and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated
  hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents,
  contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations
  of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of
  export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Risks Related to Owning our Common Stock</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>The market price of our common stock has been extremely volatile
  and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their
  investment.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The market price of our common stock may be highly
  volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>whether we achieve our anticipated corporate objectives;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>actual or anticipated fluctuations in our financial condition and operating results;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: justify">changes in financial or operational estimates or projections;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>the development status of our product candidates and when our products receive regulatory approval;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>our execution of our sales and marketing, manufacturing and other aspects of our business plan;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>performance of third parties on whom we rely to manufacture our products, product components and product candidates, including their ability to comply with regulatory requirements;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>the results of our clinical studies and clinical trials;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>results of operations that vary from those of our competitors and the expectations of securities analysts and investors;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>our announcement of significant contracts, acquisitions or capital commitments;</TD></TR>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>announcements by our competitors of competing products or other initiatives;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>announcements by third parties of significant claims or proceedings against us;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>regulatory and reimbursement developments in the United&nbsp;States and abroad;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>future sales of our common stock;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>product liability claims;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>healthcare reform measures in the United&nbsp;States;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>additions or departures of key personnel; and</TD></TR>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
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      <TD>general economic or political conditions in the United&nbsp;States or elsewhere.</TD></TR>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">In addition, the stock market in general, and the
  stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often
  been unrelated or disproportionate to the operating performance of the issuer. For example, on March 15, 2022 and April 29, 2022, the
  closing price of our common stock on Nasdaq was $67.90 and $3.59, respectively, and daily trading volume on these days was approximately
  12,500 and 988,500 shares, respectively. Additionally, our intraday trading prices have experienced extreme fluctuation. For example,
  on March 16, 2022, the difference between our high and low trading price was $46.49 and on February 22, 2022, the difference between our
  high and low trading price was $40.80 and from February 18, 2022 (the date our shares were initially listed on Nasdaq) to the date hereof,
  the market price of our common stock has fluctuated from an intra-day low on Nasdaq of $3.26 on May 2, 2022 to an intra-day high of $90.90
  per share on February 22, 2022. By comparison, our initial public offering, which closed on February 23, 2022, was conducted at $9.00
  per share. During this time, we have made one announcement regarding certain research developments for our vaccine candidates. Notwithstanding
  the foregoing, since our initial public offering on February 18, 2022, there were no material recent publicly disclosed changes in the
  financial condition or results of operations of the Company, such as our earnings or revenue, that are consistent with or related to the
  changes in our stock price. These broad market fluctuations may adversely affect the trading price of our common stock. In particular,
  a proportion of our common stock may be traded by short sellers which may put pressure on the supply and demand for our common stock,
  further influencing volatility in its market price. Additionally, these and other external factors have caused and may continue to cause
  the market price and demand for our common stock to fluctuate, which may limit or prevent investors from readily selling their shares
  of common stock and may otherwise negatively affect the liquidity of our common stock. While the market price of our common stock may
  respond to developments regarding operating performance and prospects, expansion plans, developments regarding our participation in direct
  contracting, the impacts of COVID-19, and developments regarding our industry, we believe that the extreme volatility we experienced in
  recent periods reflects market and trading dynamics unrelated to our underlying business, our actual or expected operating performance,
  our financial condition, or macro or industry fundamentals, and we do not know if these dynamics will continue or how long they will last
  .. Under these circumstances, we caution you against investing in our common stock, unless you are prepared to incur the risk of losing
  all or a substantial portion of your investment.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We may be subject to securities litigation, which is expensive
  and could divert our management&rsquo;s attention.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The market price of our securities may be volatile,
  and in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class
  action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
  costs and divert our management&rsquo;s attention from other business concerns, which could seriously harm our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Amended and Restated Certificate of Incorporation requires,
  to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers, other employees
  or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in the State of Delaware
  and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service of process on such
  stockholder&rsquo;s counsel, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
  requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,
  other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in
  the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service
  of process on such stockholder&rsquo;s counsel except any action (A)&nbsp;as to which the Court of Chancery in the State of Delaware determines
  that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent
  to the personal jurisdiction of the Court of Chancery within ten&nbsp;days following such determination), (B)&nbsp;which is vested in
  the exclusive jurisdiction of a court or forum other than the Court of Chancery, (C)&nbsp;for which the Court of Chancery does not have
  subject matter jurisdiction, or (D)&nbsp;any action arising under the Securities Act, as to which the Court of Chancery and the federal
  district court for the District of Delaware shall have concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring
  any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our Amended and
  Restated Certificate of Incorporation. This choice of forum provision may make it more costly for a stockholder to bring a claim, and
  it may also limit a stockholder&rsquo;s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any
  of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders
  cannot waive our compliance with federal securities laws and the rules and regulations thereunder. Alternatively, if a court were to find
  the choice of forum provision contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable in
  an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business,
  operating results and financial condition.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
  provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law. Section&nbsp;27 of the
  Exchange&nbsp;Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange&nbsp;Act
  or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty
  or liability created by the Exchange&nbsp;Act or any other claim for which the federal courts have exclusive jurisdiction. In addition,
  our Amended and Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum,
  the federal district courts of the United&nbsp;States of America shall, to the fullest extent permitted by law, be the exclusive forum
  for the resolution of any complaint asserting a cause of action arising under the Securities Act&nbsp;of&nbsp;1933, as amended, or the
  rules and regulations promulgated thereunder. We note, however, that there is uncertainty as to whether a court would enforce this provision
  and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section&nbsp;22
  of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability
  created by the Securities Act or the rules and regulations thereunder.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our principal stockholders and management own a significant percentage
  of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to stockholders
  for approval.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As of June 6, 2022, our officers and directors,
  together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 9,248,368
  shares of our common stock, which in the aggregate represents approximately 75.6% of the outstanding shares of our common stock. As a
  result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted
  to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate
  of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.
  These actions may be taken even if they are opposed by other stockholders. This concentration of ownership may also have the effect of
  delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could
  prevent our stockholders from receiving a premium for their shares. Some of these persons or entities who make up our principal stockholders
  may have interests different from yours.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>There can be no assurance that we will be able to comply with
  the continued listing standards of Nasdaq.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our continued eligibility for listing on Nasdaq
  depends on our ability to comply with Nasdaq&rsquo;s continued listing requirements. If Nasdaq delists the common stock from trading on
  its exchange for failure to meet the listing standards, we and our stockholders could face significant material adverse consequences including:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a limited availability of market quotations for our securities;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a determination that our common stock is a &ldquo;penny stock,&rdquo; which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a limited amount of analyst coverage; and</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in">&#9679;</TD>
      <TD>a decreased ability to issue additional securities or obtain additional financing in the future.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If our shares become subject to the penny stock rules, it would
  become more difficult to trade our shares.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The SEC has adopted rules that regulate broker-dealer
  practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00,
  other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems,
  provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system.
  If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny
  stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to
  deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before
  effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination
  that the penny stock is a suitable investment for the purchaser and receive (i)&nbsp;the purchaser&rsquo;s written acknowledgment of the
  receipt of a risk disclosure statement; (ii)&nbsp;a written agreement to transactions involving penny stocks; and (iii)&nbsp;a signed
  and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity
  in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Future sales of our shares by existing stockholders could cause
  our stock price to decline.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">If we or our existing stockholders, directors
  and officers sell, or indicate an intent to sell, substantial amounts of our common stock or securities convertible into our common stock
  in the public market after February 17, 2023 in the case of the Company and after August 16, 2022 in the case of directors, officers and
  stockholders, contractual lock-up and other legal restrictions on resale in connection with our initial public offering lapse, the trading
  price of our common stock could decline significantly. Based on 12,229,399 shares of common stock outstanding as of June&nbsp;6, 2022,&nbsp;3,403,034
  shares of common stock are freely tradable, without restriction, in the public market. If our existing stockholders sell substantial amounts
  of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on
  the market price of our common stock, even if there is no relationship between such sales and the performance of our business. We also
  intend to register all shares of common stock that we may issue under our equity compensation plan. Once we register these shares, they
  can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">After the lock-up agreements pertaining to our
  initial public offering expire, an additional 8,826,365 shares will be eligible for sale in the public market. In addition, upon issuance,
  the 1,475,180 shares subject to outstanding options under our stock option plan and the shares reserved for future issuance under our
  stock option plan will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.
  If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales
  could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such
  sales and the performance of our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are an &ldquo;emerging growth company&rdquo; and the reduced
  disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We are an &ldquo;emerging growth company,&rdquo;
  as defined in the JOBS Act. We may remain an &ldquo;emerging growth company&rdquo; until as late as December&nbsp;31, 2027 (the fiscal
  year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an &ldquo;emerging
  growth company&rdquo; earlier under certain circumstances, including (1)&nbsp;if the market value of our common stock that is held by
  nonaffiliates exceeds $700&nbsp;million as of any June&nbsp;30, in which case we would cease to be an &ldquo;emerging growth company&rdquo;
  as of the following December&nbsp;31, or (2)&nbsp;if our gross revenue exceeds $1.07&nbsp;billion in any fiscal year. &ldquo;Emerging
  growth companies&rdquo; may take advantage of certain exemptions from various reporting requirements that are applicable to other public
  companies, including not being required to comply with the auditor attestation requirements of Section&nbsp;404 of the Sarbanes-Oxley
  Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from
  the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments
  not previously approved. Investors could find our common stock less attractive because we may rely on these exemptions. If some investors
  find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price
  may be more volatile.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">In addition, Section&nbsp;102 of the JOBS Act
  also provides that an &ldquo;emerging growth company&rdquo; can take advantage of the extended transition period provided in Section&nbsp;7(a)(2)(B)&nbsp;of
  the Securities Act, for complying with new or revised accounting standards. An &ldquo;emerging growth company&rdquo; can therefore delay
  the adoption of certain accounting standards until those standards would otherwise apply to private companies.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We are subject to increased costs as a result of operating as
  a public company, and our management is required to devote substantial time to new compliance initiatives.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a public company, we incur significant legal,
  accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements.
  The Sarbanes-Oxley Act&nbsp;of&nbsp;2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The
  Nasdaq Capital Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including
  requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.
  Further, in July&nbsp;2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are
  significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional
  rules and regulations in these areas, such as &ldquo;say on pay&rdquo; and proxy access. Emerging growth companies may implement many
  of these requirements over a longer period of up to five&nbsp;years from the pricing of their initial public offering. We intend to take
  advantage of these extended transition periods but cannot guarantee that we will not be required to implement these requirements sooner
  than budgeted or planned and thereby incur unexpected expenses. Stockholder activism, the current political environment and the current
  high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which
  may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.
  Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company
  reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines
  prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote
  additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant
  legal and financial compliance costs and will make some activities more time-consuming and costly.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">To comply with the requirements of being a public
  company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting
  or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control
  over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure
  that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported
  within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Securities
  Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive and financial officers.
  Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial
  reporting may be discovered in the future. Any failure to develop or maintain effective controls when we become subject to this requirement
  could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation
  reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic
  reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results,
  cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that
  we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived
  as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating
  results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may
  not be able to remain listed on Nasdaq.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The rules and regulations applicable to public
  companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
  If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse
  effect on our business, financial condition, and results of operations. The increased costs will decrease our net income and may require
  us to reduce costs in other areas of our business or increase the prices of our products or services. For example, these rules and regulations
  made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial
  costs in the future to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we
  may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain
  qualified persons to serve on our board of directors, our board committees or as executive officers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
  <!-- Field: Page; Sequence: 109; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our management team has limited experience managing a public
  company.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Most members of our management team have limited
  experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws
  pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company
  subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of
  securities analysts and investors. These new obligations and constituents require significant attention from our senior management and
  could divert their attention away from the&nbsp;day-to-day management of our business, which could adversely affect our business, financial
  condition and operating results.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If we fail to maintain an effective system of internal controls,
  we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our
  business and operating results and cause the trading price of our stock to decline.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Effective internal controls required under Section&nbsp;404
  of the Sarbanes-Oxley Act, are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide
  reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed. We have discovered, and may
  in the future discover, areas of our internal controls that need improvement. We cannot be certain that the measures we have taken or
  intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future. Any failure to
  implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,
  harm our business and operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also harm
  our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the
  trading price of our stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>If securities or industry analysts do not publish research, or
  publish inaccurate or unfavorable research, about our business, our stock price and our trading volume could decline.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">The trading market for our common stock depends,
  in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts
  may never publish research on us. If no or few securities or industry analysts commence coverage of us, the price for our common stock
  could be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover
  us downgrade our common stock or publish inaccurate or unfavorable research about our business, our stock price could decline. In addition,
  if our operating results fail to meet the forecast of analysts, our stock price could decline. If one or more of these analysts cease
  coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price
  and trading volume to decline.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>Our Amended and Restated Certificate of Incorporation and our
  Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control,
  which may cause our stock price to decline.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Our Amended and Restated Certificate of Incorporation
  and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing such
  a transaction would be beneficial to our stockholders. Our Amended and Restated Certificate of Incorporation authorizes us to issue up
  to 10,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined
  at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may
  include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion
  and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of
  the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future
  holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve
  control by the present management.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <!-- Field: Page; Sequence: 110; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Provisions of our Amended and Restated Certificate
  of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals
  or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such
  provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Amended
  and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: left">provide the board of directors with the ability to alter the bylaws without stockholder approval;</TD></TR>
    </TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: left">place limitations on the removal of directors;</TD></TR>
    </TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: left">establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and</TD></TR>
    </TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: left; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: left; width: 0.25in">&#9679;</TD>
      <TD STYLE="text-align: left">provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.</TD></TR>
    </TABLE>
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48pt; text-indent: -24pt">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">These provisions, alone or together, could delay
  or prevent hostile takeovers and changes in control or changes in our management.</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">As a Delaware corporation, we are also subject
  to provisions of Delaware law, including Section&nbsp;203 of the Delaware General Corporation law, which prevents certain stockholders
  holding more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of the holders
  of at least two-thirds of our outstanding common stock not held by such stockholder.</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Any provision of our Amended and Restated Certificate
  of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing or deterring a change in control
  could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the
  price that some investors are willing to pay for our common stock.</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><I>We do not anticipate paying any cash dividends on our common
  stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the
  foreseeable future.</I></B></P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">We have never declared or paid cash dividends
  on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend
  to retain all available funds and any future earnings to fund the development and growth of our business. In addition, and any future
  loan arrangements we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our
  common stock. As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of gain
  for the foreseeable future.</P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left; margin: 0pt 0"><B><I>A possible &ldquo;short squeeze&rdquo; due to a sudden increase
  in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.</I></B></P>
  
  <P STYLE="text-align: left; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin: 0pt 0; text-align: left">Investors may purchase our common stock to hedge
  existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may
  involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for
  purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders
  of our common stock. Those repurchases may in turn, dramatically increase the price of our common stock until investors with short exposure
  are able to purchase additional common shares to cover their short position. This is often referred to as a &ldquo;short squeeze.&rdquo;
  A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects
  of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common
  stock may decline.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B></B></P>
  
  <!-- Field: Page; Sequence: 111; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_006"></A>SELLING STOCKHOLDERS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The following table sets
  forth (a) the name and position or positions with the Company of each Selling Stockholder; (b) the aggregate of (i) the number of shares
  of Common Stock held by each Selling Stockholder as of the date of this prospectus and (ii) the number of shares issuable upon exercise
  of options granted to each Selling Stockholder under the 2019 Plan and the 2022 Plan that are being registered pursuant to this Registration
  Statement for resale by each Selling Stockholder as of the date of this prospectus; (c) the number of shares of Common Stock issuable
  upon exercise of options that each Selling Stockholder may offer for sale from time to time pursuant to this prospectus, whether or not
  such Selling Stockholder has a present intention to do so; and (d) the number of shares of Common Stock to be beneficially owned by each
  Selling Stockholder following the sale of all shares that may be so offered pursuant to this prospectus, assuming no other change in ownership
  of Common Stock by such Selling Stockholder after the date of this prospectus. Unless otherwise indicated, beneficial ownership is direct
  and the person indicated has sole voting and investment power.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
  may, from time to time, resell all, a portion or none of the shares of our Common Stock covered by this reoffer prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Inclusion of an individual&rsquo;s
  name in the table below does not constitute an admission that such individual is an &ldquo;affiliate&rdquo; of the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
    <TR STYLE="vertical-align: bottom; background-color: white">
      <TD STYLE="border-bottom: black 1.5pt solid"><FONT STYLE="font-size: 10pt"><B>Selling Stockholder</B></FONT></TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Principal Position with<BR>
  the&nbsp;Company (1)</B></FONT></TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD COLSPAN="5" STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Shares Owned<BR>
  Prior to Resale<BR>
  (2)</B></FONT></TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number of Shares<BR>
  Offered for Resale</B></FONT></TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD COLSPAN="6" STYLE="border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Shares Beneficially Owned<BR>
  After Resale</B></FONT></TD>
      <TD STYLE="padding-bottom: 1.5pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number</B></FONT></TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Percent</B></FONT></TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Number</B></FONT></TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Percent</B></FONT></TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 1.5pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top; width: 23%"><FONT STYLE="font-size: 10pt">Joseph Hernandez</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 17%"><FONT STYLE="font-size: 10pt">Chairman and Chief Executive Officer</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">3,400,000</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">27.35</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">200,000</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">3,200,000</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">25.75</FONT></TD>
      <TD STYLE="vertical-align: bottom; width: 1%"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Erin Henderson </FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Chief Business Officer and Secretary </FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">245,920</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">1.97</FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">245,920</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Jon Garfield</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Chief Financial Officer</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">100,000</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">100,000</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt"></FONT>&mdash;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Kimberly Murphy</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Allan Shaw</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt"></FONT>&mdash;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">James Sapirstein</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">50,575</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Michael Venerable</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">4,655</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Brian Price</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">91,840</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">91,840</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">David Zarley</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">45,920</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">* </FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">45,920</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: white">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">CincyTech Fund IV, LLC</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Consultant</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">851,988</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">6.94</FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">45,920</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">806,068</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">6.57</FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    <TR STYLE="background-color: #CCEEFF">
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Sunetra Gupta</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Advisory Board Member</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">459,200</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">3.62</FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right"><FONT STYLE="font-size: 10pt">459,200</FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: right">&mdash;<FONT STYLE="font-size: 10pt"></FONT></TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">%</FONT></TD></TR>
    </TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in; text-align: left">*</TD><TD STYLE="text-align: justify">Less than 1%.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; text-align: justify">(1)</TD>
      <TD STYLE="text-align: justify">All positions described are with the Company, unless otherwise indicated.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">(2)</TD>
      <TD>The number of shares owned prior to resale by each Selling Stockholder shares of Common Stock owned on or about the date hereof by the Selling Stockholders and shares of common stock that are issued or to be issued, or which may be acquired upon the exercise of stock options issued or to be issued, or vesting of restricted stock awards issued or to be issued, pursuant to the 2019 Plan and the 2022 Plan.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The
  Company may supplement this prospectus from time to time as required by the rules of the Commission to include certain information concerning
  the security ownership of the Selling Stockholders or any new Selling Stockholders, the number of securities offered for resale and the
  position, office or other material relationship which a Selling Stockholder has had within the past three years with the Company or any
  of its predecessors or affiliates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"></P>
  
  <!-- Field: Page; Sequence: 112; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><P STYLE="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->106<!-- Field: /Sequence --></P></DIV>
      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="a_007"></A>USE OF PROCEEDS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">We will not receive any proceeds
  from the resale of our Common Stock by the Selling Stockholders pursuant to this prospectus. However, we will receive the exercise price
  of any Common Stock issued to the Selling Stockholders upon cash exercise by them of their options. We would expect to use these proceeds,
  if any, for general working capital purposes. We have agreed to pay the expenses of registration of these shares.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="a_008"></A>PLAN OF DISTRIBUTION</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: justify">In this section of the prospectus,
  the term &ldquo;Selling Stockholder&rdquo; means and includes:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR>
      <TD STYLE="width: 0.25in; padding-right: 0.65pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; width: 0.25in; padding-right: 0.65pt; text-align: justify">&#9679;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.8pt; text-align: left">the persons identified in the table above as the Selling Stockholders;</TD></TR>
    <TR>
      <TD STYLE="padding-right: 0.65pt; text-align: left">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.65pt; text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left; vertical-align: top">&nbsp;</TD></TR>
    <TR>
      <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&#9679;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.8pt; text-align: left">those persons whose identities are not known as of the date hereof but may in the future be eligible to receive options under the 2019 Plan or the 2022 Plan; and</TD></TR>
    <TR>
      <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left; vertical-align: top; padding-right: 1.05pt">&nbsp;</TD></TR>
    <TR>
      <TD STYLE="padding-right: 0.85pt; text-align: left">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">&#9679;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.85pt; text-align: left">any of the donees, pledgees, distributees, transferees or other successors in interest of those persons referenced above who may: (a) receive any of the shares of our Common Stock offered hereby after the date of this prospectus and (b) offer or sell those shares hereunder.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The shares of our Common
  Stock offered by this prospectus may be sold from time to time directly by the Selling Stockholders. Alternatively, the Selling Stockholders
  may from time to time offer such shares through underwriters, brokers, dealers, agents or other intermediaries. The Selling Stockholders
  as of the date of this prospectus have advised us that there were no underwriting or distribution arrangements entered into with respect
  to the Common Stock offered hereby. The distribution of the Common Stock by the Selling Stockholders may be effected: in one or more transactions
  that may take place on The Nasdaq Capital Market (including one or more block transactions) through customary brokerage channels, either
  through brokers acting as agents for the Selling Stockholders, or through market makers, dealers or underwriters acting as principals
  who may resell these shares on The Nasdaq Capital Market; in privately-negotiated sales; by a combination of such methods; or by other
  means. These transactions may be effected at market prices prevailing at the time of sale, at prices related to such prevailing market
  prices or at other negotiated prices. Usual and customary or specifically negotiated brokerage fees or commissions may be paid by the
  Selling Stockholders in connection with sales of our Common Stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
  may enter into hedging transactions with broker-dealers in connection with distributions of the shares or otherwise. In such transactions,
  broker-dealers may engage in short sales of the shares of our Common Stock in the course of hedging the positions they assume with the
  Selling Stockholders. The Selling Stockholders also may sell shares short and redeliver the shares to close out such short positions.
  The Selling Stockholders may enter into option or other transactions with broker-dealers which require the delivery to the broker-dealer
  of shares of our Common Stock. The broker-dealer may then resell or otherwise transfer such shares of Common Stock pursuant to this prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">At the time a particular
  offering of shares of our Common Stock is made, a prospectus supplement, if required, will be distributed, which will set forth the name
  of the Selling Stockholders, the aggregate amount of shares of our Common Stock being offered and the terms of the offering, including,
  to the extent required, (1) the name or names of any underwriters, broker-dealers or agents, (2) any discounts, commissions and other
  terms constituting compensation from the Selling Stockholders and (3) any discounts, commissions or concessions allowed or reallowed to
  be paid to broker-dealers.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
  also may lend or pledge shares of our Common Stock to a broker-dealer. The broker-dealer may sell the shares of Common Stock so lent,
  or upon a default the broker-dealer may sell the pledged shares of Common Stock pursuant to this prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
  will act independently of us in making decisions with respect to the timing, manner, and size of each resale or other transfer. There
  can be no assurance that the Selling Stockholders will sell any or all of the shares of our Common Stock under this prospectus. Further,
  we cannot assure you that the Selling Stockholders will not transfer, distribute, devise or gift the shares of our Common Stock by other
  means not described in this prospectus. In addition, any Shares covered by this prospectus that qualify for sale under Rule&nbsp;144&nbsp;of
  the&nbsp;Securities Act&nbsp;may be sold under Rule 144 rather than under this prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></P>
  
  <!-- Field: Page; Sequence: 113; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The Selling Stockholders
  have advised us that they have not entered into any agreements, understandings or arrangements with any underwriters or broker-dealers
  regarding the sale of their securities. There is no underwriter or coordinating broker acting in connection with the proposed sale of
  shares of Common Stock the Selling Stockholders.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Although the shares of Common
  Stock covered by this prospectus are not currently being underwritten, the Selling Stockholders or their underwriters, brokers, dealers
  or other agents or other intermediaries, if any, that may participate with the selling security holders in any offering or distribution
  of Common Stock may be deemed &ldquo;underwriters&rdquo; within the meaning of the Securities Act and any profits realized or commissions
  received by them may be deemed underwriting compensation thereunder.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Under applicable rules and
  regulations under the Exchange Act, any person engaged in a distribution of shares of the Common Stock offered hereby may not simultaneously
  engage in market making activities with respect to the Common Stock for a period of up to five days preceding such distribution. The Selling
  Stockholders will be subject to the applicable provisions of the Exchange Act and the rules and regulations promulgated thereunder, including
  without limitation Regulation M, which provisions may limit the timing of purchases and sales by the Selling Stockholders.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">In order to comply with certain
  state securities or blue sky laws and regulations, if applicable, the Common Stock offered hereby will be sold in such jurisdictions only
  through registered or licensed brokers or dealers. In certain states, the Common Stock may not be sold unless they are registered or qualified
  for sale in such state, or unless an exemption from registration or qualification is available and is obtained.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">We will bear all costs, expenses
  and fees in connection with the registration of the Common Stock offered hereby. However, the Selling Stockholders will bear any brokerage
  or underwriting commissions and similar selling expenses, if any, attributable to the sale of the shares of Common Stock offered pursuant
  to this prospectus. We have agreed to indemnify the Selling Stockholders against certain liabilities, including liabilities under the
  Securities Act, or to contribute to payments to which any of those security holders may be required to make in respect thereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_009"></A>LEGAL MATTERS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The validity of the securities
  being offered herein has been passed upon for us by Ellenoff Grossman &amp; Schole LLP, New York, New York.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B><A NAME="a_010"></A>EXPERTS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">The financial statements
  of Blue Water Vaccines Inc. as of and for the&nbsp;years ended December&nbsp;31, 2021 and 2020, incorporated by reference in this registration
  statement, of which this prospectus forms a part, have been audited by Mayer Hoffman McCann P.C., independent registered public accounting
  firm, and are incorporated in reliance upon such report given on the authority of such firm as experts in auditing and accounting in giving
  said report.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>DISCLOSURE OF COMMISSION POSITION ON</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INDEMNIFICATION FOR SECURITIES LAWS VIOLATIONS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Section 145 of the DGCL inter
  alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
  pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
  such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
  as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys&rsquo; fees),
  judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
  if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
  with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
  for such persons against expenses (including attorneys&rsquo; fees) actually and reasonably incurred in connection with the defense or
  settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
  believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
  otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
  in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
  opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 further authorizes
  a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
  or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
  against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
  not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
  directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Section 102(b)(7) of the
  DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
  a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
  provision shall not eliminate or limit the liability of a director (i) for any breach of the director&rsquo;s duty of loyalty to the corporation
  or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
  (iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
  any transaction from which the director derived an improper personal benefit.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in; text-align: left">Article 6 of the bylaws of
  the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
  full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
  DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
  delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
  determined that such director is not entitled to indemnification.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  <!-- Field: Rule-Page --><DIV STYLE="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in"><B>You should rely only on
  the information contained in this document. We have not authorized anyone to provide you with information that is different. This document
  may only be used where it is legal to sell these securities. The information in this document may only be accurate on the date of this
  document.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in"><B>Additional risks and uncertainties
  not presently known or that are currently deemed immaterial may also impair our business operations. The risks and uncertainties described
  in this document and other risks and uncertainties which we may face in the future will have a greater impact on those who purchase our
  common stock. These purchasers will purchase our common stock at the market price or at a privately negotiated price and will run the
  risk of losing their entire investment.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>BLUE WATER VACCINES INC.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>1,600,000 Shares of</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Common Stock</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PROSPECTUS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>June 24, 2022</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"></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>
  
  <!-- Field: Rule-Page --><DIV STYLE="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 1pt solid; border-bottom: Black 2pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->
  
  <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>
  
  <!-- Field: Page; Sequence: 116 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>PART II</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>INFORMATION NOT REQUIRED IN PROSPECTUS</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 3.</B> <B>Incorporation of Documents by Reference</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">We
  are &ldquo;incorporating by reference&rdquo; in this prospectus certain documents we file with the Commission, which means that we can
  disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
  is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
  by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
  in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
  differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
  are incorporated herein by reference as of their respective dates of filing.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white"></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 1.05pt; text-align: left">(i)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Annual Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022016672/f10k2021_bluewater.htm">Form 10-K</A> for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">(ii)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Quarterly Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022026516/f10q0322_bluewatervac.htm">Form 10-Q</A> for the quarter ended March 31, 2022 as filed with the SEC on May 13, 2022;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">(iii)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022010779/ea156505-8ka1_bluewater.htm">Form
      8-K/A</A> dated March 4, 2022, our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022014172/ea157195-8k_bluewater.htm">Form
      8-K</A> dated March 22, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020636/ea158617-8k_bluewater.htm">Form
      8-K</A> dated April 19, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020726/ea158657-8k_bluewater.htm">Form
      8-K</A> dated April 20, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020785/ea158659-8k_bluewater.htm">Form
      8-K</A> dated April 20, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022020876/ea158704-8k_bluewater.htm">Form
      8-K</A> dated April 21, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022029402/ea160571-8k_bluewater.htm">Form
      8-K</A> dated May 25, 2022; our Current Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022030666/ea160890-8k_bluewater.htm">Form
      8-K</A> dated June 1, 2022; and our Current Report on <A HREF="https://www.sec.gov/Archives/edgar/data/1782107/000121390022034900/ea161977-8k_bluewater.htm">Form 8-K</A> dated June 24, 2022.</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="padding-right: 1.05pt; text-align: left">&nbsp;</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">(iv)</TD>
      <TD STYLE="padding-right: 1.05pt; text-align: left">the description of our securities registered under Section 12 of the Exchange Act as filed as&nbsp;<A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022016672/f10k2021ex4-2_bluewater.htm">Exhibit 4.2</A>&nbsp;on Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.45in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">All documents that we file
  with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
  indicate that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold, will
  be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Any statement contained in
  a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
  for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
  also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
  superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
  of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
  furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
  by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
  to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
  incorporated by reference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">You may request, orally or in writing, a copy
  of these documents, which will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated
  by reference), by contacting Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our
  telephone number is (513) 620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However,
  the information on our website is not a part of this prospectus and is not incorporated by reference.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 4.</B> <B>Description of Securities</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">Not applicable.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 5.</B> <B>Interests of Named Experts and Counsel</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">Not applicable.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 6.</B> <B>Indemnification of Officers and Directors</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 of the DGCL inter
  alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
  pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
  such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
  as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys&rsquo; fees),
  judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
  if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
  with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
  for such persons against expenses (including attorneys&rsquo; fees) actually and reasonably incurred in connection with the defense or
  settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
  believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
  otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
  in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
  opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 145 further authorizes
  a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
  or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
  against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
  not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
  directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Section 102(b)(7) of the
  DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
  a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
  provision shall not eliminate or limit the liability of a director (i) for any breach of the director&rsquo;s duty of loyalty to the corporation
  or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
  (iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
  any transaction from which the director derived an improper personal benefit.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Article 6 of the bylaws of
  the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
  full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
  DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
  delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
  determined that such director is not entitled to indemnification.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 7.</B> <B>Exemption from Registration Claimed</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">Not applicable.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 8.</B> <B>Exhibits</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 22.05pt">The following exhibits are
  filed with this Registration Statement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR>
      <TD STYLE="border-bottom: black 1.5pt solid; vertical-align: bottom; width: 10%; text-align: center"><B>Number</B></TD>
      <TD STYLE="vertical-align: top; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: top; border-bottom: black 1.5pt solid; text-align: justify; width: 89%"><B>Description</B></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.1</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390021052037/fs12021ex10-1_bluewater.htm">2019 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.2</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-2_bluewater.htm">2022 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.3</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390021052037/fs12021ex10-3_bluewater.htm">2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (Incorporated by reference to Exhibit 10.3 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.4</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-4_bluewater.htm">2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.5</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-5_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (Incorporated by reference to Exhibit 10.5 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.6</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-6_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (Incorporated by reference to Exhibit 10.6 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">4.7</TD>
      <TD STYLE="text-align: left">&nbsp;</TD>
      <TD STYLE="text-align: left"><A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022000991/fs12022a5ex10-7_bluewater.htm">2022 Equity Incentive Plan Form of Nonstatuory Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.7 to our Registration Statement on Form S-1/A, dated February 8, 2022.)</A> </TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">5.1</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea161764ex5-1_blue.htm">Opinion of Ellenoff Grossman &amp; Schole LLP (Filed herewith)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">23.1</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea161764ex23-1_blue.htm">Consent of Mayer Hoffman McCann P.C. (Filed herewith)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">23.2</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea161764ex5-1_blue.htm">Consent of Ellenoff Grossman &amp; Schole LLP (included in Exhibit 5.1)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">24</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="#c_001">Powers of Attorney (included on signature page)</A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: White">
      <TD STYLE="text-align: center">&nbsp;</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: center">107</TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea161764ex-fee_blue.htm">Filing Fee Table. (Filed herwith)</A></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><B>Item 9.</B> <B>Undertakings.</B></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">The undersigned registrant hereby undertakes:</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">To file, during any period in which offers or sales are being
  made, a post-effective amendment to this registration statement</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; width: 100%"><TR STYLE="vertical-align: top; text-align: justify">
  <TD STYLE="width: 0.5in"></TD><TD STYLE="width: 0.25in; text-align: left">(II)</TD><TD STYLE="text-align: justify">To include any material information with respect to the plan
  of distribution not previously disclosed in the registration statement or any material change to such information in the registration
  statement.</TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(2) That, for the purpose
  of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration
  statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
  bona fide offering thereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(3) To remove from registration
  by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">(4) That prior to any public reoffering of the
  securities registered hereunder through use of a prospectus which is a part of this registration statement, by any person or party who
  is deemed to be an underwriter within the meaning of Rule 145&copy;, such reoffering prospectus will contain the information called for
  by the applicable registration form with respect to reofferings by persons who may be deemed underwriters, in addition to the information
  called for by the other items of the applicable form.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 119; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(5) That every prospectus
  (i) that is filed pursuant to paragraph (4) immediately preceding, or (ii) that purports to meet the requirements of Section 10(a)(3)
  of the Securities Act of 1933 and is used in connection with an offering of securities subject to Rule 415, will be filed as a part of
  an amendment to the registration statement and will not be used until such amendment is effective, and that, for purposes of determining
  any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement
  relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide
  offering thereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(6) That, for purposes of
  determining any liability under the Securities Act of 1933, each filing of the registrant&rsquo;s annual report pursuant to Section 13(a)
  or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan&rsquo;s annual report
  pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall
  be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
  shall be deemed to be the initial bona fide offering thereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(7) To respond to requests
  for information that is incorporated by reference into the joint proxy statement/prospectus pursuant to Item 4, 10(b), 11 or 13 of this
  form, within one business day of receipt of such request, and to send the incorporated documents by first class mail or other equally
  prompt means. This includes information contained in documents filed subsequent to the effective date of the registration statement through
  the date of responding to the request.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">(8) To supply by means of
  a post-effective amendment all information concerning a transaction, and the company being acquired involved therein, that was not the
  subject of and included in the registration statement when it became effective.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">(b) Insofar as indemnification for liabilities
  arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to
  the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
  such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a
  claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
  officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director,
  officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel
  the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
  by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">(c) The undersigned registrant hereby undertakes
  that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant&rsquo;s annual report
  pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
  plan&rsquo;s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the
  registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
  of such securities at that time shall be deemed to be the initial bona fide offering thereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
  
  <!-- Field: Page; Sequence: 120; Value: 1 -->
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      <DIV STYLE="break-before: page; margin-top: 6pt; margin-bottom: 12pt"><P STYLE="margin: 0pt">&nbsp;</P></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.25in">Pursuant to the requirements of the Securities
  Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for
  filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized,
  on June 24, 2022.</P>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: justify"><B>BLUE WATER VACCINES INC.</B></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 60%; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 4%; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 36%; text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">By:</TD>
      <TD STYLE="border-bottom: black 1.5pt solid">/s/ Joseph Hernandez</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">Joseph Hernandez</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">Chief Executive Officer</TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; background-color: white"><B><A NAME="c_001"></A>POWER OF ATTORNEY</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in"><B>KNOW ALL MEN BY THESE PRESENTS</B>, that we,
  the undersigned officers and directors of Blue Water Vaccines, Inc., a Delaware corporation, do hereby constitute and appoint Joseph Hernandez,
  as his or her true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, for him and in his name,
  place, and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and
  other documents in connection therewith) to this Registration Statement and any subsequent registration statement filed by the registrant
  pursuant to Rule&nbsp;462(b) of the Securities Act of 1933, as amended, which relates to this Registration Statement, and to file the
  same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto
  said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be
  done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming
  all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.25in">Pursuant to the requirements of the Securities Act
  of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 24pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="width: 32%; border-bottom: black 1.5pt solid; padding-right: 3pt"><FONT STYLE="font-size: 10pt"><B>Name</B></FONT></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="width: 43%; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Position</B></FONT></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="width: 23%; border-bottom: black 1.5pt solid; text-align: center"><FONT STYLE="font-size: 10pt"><B>Date</B></FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ Joseph Hernandez</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Chairman of the Board and Chief Executive Officer (Principal Executive Officer)</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR>
      <TD STYLE="vertical-align: top"><FONT STYLE="font-size: 10pt">Joseph Hernandez</FONT></TD>
      <TD STYLE="white-space: nowrap; vertical-align: top; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom"><FONT STYLE="font-size: 10pt">Chief Financial Officer (Principal Financial Officer)</FONT></TD>
      <TD STYLE="white-space: nowrap; vertical-align: bottom; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 2.25pt">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ Jon Garfield</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD><FONT STYLE="font-size: 10pt">Jon Garfield</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ Kimberly Murphy</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD><FONT STYLE="font-size: 10pt">Kimberly Murphy</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ James Sapirstein</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD><FONT STYLE="font-size: 10pt">James Sapirstein</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ Allan L. Shaw</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD><FONT STYLE="font-size: 10pt">Allan L. Shaw</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt"><FONT STYLE="font-size: 10pt">/s/ Michael Venerable</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">June 24, 2022</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD><FONT STYLE="font-size: 10pt">Michael Venerable</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt">&nbsp;</TD></TR>
    </TABLE>
  
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metadata_documents: [{"type": "S-8", "sequence": "1", "filename": "ea161764-s8_bluewater.htm", "description": "REGISTRATION STATEMENT", "secsgml_size_bytes": 944284}]
metadata_filer: {"company-data": {"conformed-name": "Blue Water Vaccines Inc.", "cik": "0001782107", "assigned-sic": "2834", "irs-number": "000000000", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "S-8", "act": "33", "file-number": "333-265843", "film-number": "221041427"}, "business-address": {"street1": "2041 COURTLAND AVENUE", "city": "CINCINNATI", "state": "OH", "zip": "45212", "phone": "646-303-0737"}, "mail-address": {"street1": "2041 COURTLAND AVENUE", "city": "CINCINNATI", "state": "OH", "zip": "45212"}}
text: As filed with the Securities and Exchange Commission on June 24,
  2022
  Registration No. 333-______________
  UNITED STATES
  SECURITIES AND
  EXCHANGE COMMISSION
  Washington, D.C. 20549
  FORM S-8
  REGISTRATION STATEMENT UNDER THE SECURITIES
  ACT OF 1933
  Blue Water Vaccines
  Inc.
  (Exact name of registrant as specified in charter)
  Delaware
  81-2262816
  (State or Other Jurisdiction of
  Incorporation or Organization)
  (IRS Employer
  Identification No.)
  201 E. Fifth Street, Suite 1900
  Cincinnati, OH
  45202
  (Address of Principal Executive Offices)
  (Zip Code)
  Blue Water Vaccines Inc. 2019 Equity
      Incentive Plan
  Blue Water Vaccines Inc. 2022 Equity
      Incentive Plan
  (Full Title of the Plan)
  Joseph Hernandez
  Chief Executive Officer
  Blue Water Vaccines Inc.
  201 E. Fifth Street, Suite 1900
  Cincinnati, OH 45202
  (Name and Address of Agent For Service)
  (513) 620-4101
  Telephone Number, Including Area Code of Agent
  For Service.
  Copy to:
  Barry I. Grossman, Esq.
  Jessica Yuan, Esq.
  Ellenoff Grossman & Schole LLP
  1345 Avenue of the Americas, 11th Floor
  New York, New York 10105
  Telephone: (212) 370-1300
  Facsimile: (212) 370-7889
  Indicate by check mark whether the registrant
  is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
  See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company"
  and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):
  Large accelerated filer
  ☐
  Accelerated filer
  ☐
  Non-accelerated filer
  ☒
  Smaller reporting company
  ☒
  Emerging growth company
  ☒
  If an emerging growth company, indicate by check
  mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
  standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
  ☐
  Explanatory Note
  This Registration Statement
  is being filed by the Registrant relating to 780,640 shares of our common stock which may be offered and sold pursuant to our 2019 Equity
  Incentive Plan (the "2019 Plan") and 819,360 shares of our common stock, par value $0.0001 per share (the "Common Stock")
  which may be offered and sold pursuant to our 2022 Equity Incentive Plan (the "2022 Plan").
  This Registration Statement
  includes, pursuant to General Instruction C to Form S-8, a re-offer prospectus in Part I (the "Reoffer Prospectus"). The Reoffer
  Prospectus may be utilized for reofferings and resales by certain employees, executive officers and directors listed in the Reoffer Prospectus
  who may be deemed "affiliates" of the Company on a continuous or a delayed basis in the future of up to 1,600,000 shares of
  Common Stock. These shares constitute "control securities" or "restricted securities" within the meaning of the Securities
  Act of 1933, as amended (the "Securities Act"), and the rules and regulations promulgated thereunder, which have been issued
  prior to or issuable after the filing of this Registration Statement. The Reoffer Prospectus does not contain all of the information included
  in the Registration Statement, certain items of which are contained in schedules and exhibits to the Registration Statement, as permitted
  by the rules and regulations of the SEC. Statements contained in this Reoffer Prospectus as to the contents of any agreement, instrument
  or other document referred to are not necessarily complete. With respect to each such agreement, instrument or other document filed as
  an exhibit to the Registration Statement, we refer you to the exhibit for a more complete description of the matter involved, and each
  such statement shall be deemed qualified in its entirety by this reference.
  As specified in General Instruction
  C of Form S-8, until such time as we meet the registrant requirements for use of Form S-3, the number of shares of Common Stock to be
  offered by means of the Reoffer Prospectus, by each of the selling security holders, and any other person with whom he or she is acting
  in concert for the purpose of selling our shares of Common Stock, may not exceed, during any three month period, the amount specified
  in Rule 144(e) of the Securities Act.
  PART I
  INFORMATION REQUIRED IN THE SECTION 10(a) PROSPECTUS
  Blue Water Vaccines Inc.,
  a Delaware corporation (the "Company", "us", "our" or "we"), has prepared this Registration
  Statement on Form S-8 (the "Registration Statement") in accordance with the requirements of Form S-8 under the Securities
  Act of 1933, as amended (the "Securities Act"), to register 1,600,000 shares of our common stock, par value $0.00001 per share
  (the "Common Stock"), which may be offered and sold pursuant to the 2019 Plan and the 2022 Plan and to file a prospectus,
  prepared in accordance with the requirements of Part I of Form S-3 and, pursuant to General Instruction C of Form S-8, to be used for
  reoffers and resales of Common Stock acquired by persons to be named therein upon the exercise of options and restricted stock awards
  granted under the 2019 Plan and the 2022 Plan.
  Pursuant to the Note to Part
  I on Form S-8, the documents containing the information specified in Part I of this Registration Statement will be sent or given to plan
  participants as specified by Rule 428(b)(1) of the Securities Act. Such documents are not required to be filed, and are not filed, with
  the United States Securities and Exchange Commission either as part of this Registration Statement or as prospectuses or prospectus supplements
  pursuant to Rule 424 of the Securities Act. These documents and the documents incorporated by reference in this Registration Statement
  pursuant to Item 3 of Part II of this Form S-8, taken together, constitute a prospectus that meets the requirements of Section 10(a) of
  the Securities Act.
  REOFFER PROSPECTUS
  Blue Water Vaccines
  Inc.
  Up to 1,600,000 shares
  of Common Stock under the 2019 Equity Incentive Plan and 2022 Equity Incentive Plan
  This
  prospectus relates to the resale of up to 1,600,000 shares (the "Shares") of common stock, par value $0.00001 per share (the
  "Common Stock"), of Blue Water Vaccines Inc., a Delaware corporation (the "Company", "us", "our"
  or "we"), which may be offered and sold from time to time by certain stockholders of the Company (the "Selling Stockholders")
  who have acquired or will acquire such Shares in connection with the exercise of stock options granted, and with stock or other awards
  made, and with the purchase of stock under, the 2019 Plan or the 2022 Plan. The 2019 Plan and the 2022 Plan are intended to provide incentives
  which will attract, retain, and motivate highly competent persons such as officers, employees, directors, and consultants to our Company
  by providing them opportunities to acquire shares of our Common Stock. Additionally, the 2019 Plan and the 2022 Plan are intended to assist
  in further aligning the interests of our officers, employees, directors and consultants to those of the Company's other stockholders.
  The persons who are issued such Shares may include our directors, officers,
  employees and consultants, certain of whom may be considered our "affiliates". Such persons may, but are not required to,
  sell the Shares they acquire pursuant to this prospectus. If any additional awards are issued to or Shares are purchased by affiliates
  under the 2019 Plan or the 2022 Plan, we will file with the Securities and Exchange Commission (the "Commission") an update
  to this prospectus naming such person as a selling shareholder and indicating the number of shares such person is offering pursuant to
  the prospectus. See "Selling Stockholders" on page 106 of this prospectus. Our Common Stock is listed on The Nasdaq Capital
  Market under the symbol "BWV." On June 17, 2022, the closing price of the Common Stock on The Nasdaq Capital Market was $2.50
  per share.
  Our shares of common stock have experienced extreme volatility in market
  prices and trading volume since listing. From February 18, 2022 (the date our shares were initially listed on Nasdaq) to the date hereof,
  the market price of our common stock has fluctuated from an intra-day low on Nasdaq of $2.46 on June 17, 2022 to an intra-day high of
  $90.90 per share on February 22, 2022. By comparison, our initial public offering, which closed on February 23, 2022, was conducted at
  $9.00 per share. During this time, we have made one announcement regarding certain research developments for our vaccine candidates. Notwithstanding
  the foregoing, since our initial public offering on February 18, 2022, there were no material recent publicly disclosed changes in the
  financial condition or results of operations of the Company, such as our earnings or revenue, that are consistent with or related to the
  changes in our stock price. The trading price of our common stock has been, and may continue to be, subject to wide price fluctuations
  in response to various factors, many of which are beyond our control, including those described under the heading "Risk Factors"
  beginning on page 63 of this prospectus.
  We
  will not receive any of the proceeds from sales of the Shares by any of the Selling Stockholders. The Shares may be offered from time
  to time by any or all of the Selling Stockholders through ordinary brokerage transactions, in negotiated transactions or in other transactions,
  at such prices as such Selling Stockholder may determine, which may relate to market prices prevailing at the time of sale or be a negotiated
  price. See "Plan of Distribution." Sales may be made through brokers or to dealers, who are expected to receive customary
  commissions or discounts. We are paying all expenses of registration incurred in connection with this offering but the Selling Stockholders
  will pay all brokerage commissions and other selling expenses.
  The
  Selling Stockholders and participating brokers and dealers may be deemed to be "underwriters" within the meaning of the Securities
  Act, in which event any profit on the sale of shares of those Selling Stockholders and any commissions or discounts received by those
  brokers or dealers may be deemed to be underwriting compensation under the Securities Act.
  SEE
  "RISK FACTORS" BEGINNING ON PAGE 63 OF THIS PROSPECTUS FOR A DISCUSSION OF CERTAIN RISKS AND OTHER FACTORS THAT YOU SHOULD
  CONSIDER BEFORE PURCHASING OUR COMMON STOCK.
  Neither
  the Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is
  truthful or complete. Any representation to the contrary is a criminal offense.
  The date of this prospectus
  is June 24, 2022.
  TABLE OF CONTENTS
  Page No
  Where You Can Find More Information
  ii
  Prospectus Summary
  1
  Incorporation of Certain Documents By Reference
  5
  Note on Forward Looking Statements
  6
  The Company
  8
  Risk Factors
  63
  Selling Stockholders
  106
  Use of Proceeds
  107
  Plan of Distribution
  107
  Legal Matters
  108
  Experts
  108
  You should rely only on the
  information contained in or incorporated by reference into this prospectus or any prospectus supplement. We have not authorized any person
  to give any information or to make any representations other than those contained or incorporated by reference in this prospectus, and,
  if given or made, you must not rely upon such information or representations as having been authorized. This prospectus does not constitute
  an offer to sell or the solicitation of an offer to buy any securities other than our shares of Common Stock described in this prospectus
  or an offer to sell or the solicitation to buy such securities in any circumstances in which such offer or solicitation is unlawful. You
  should not assume that the information we have included in this prospectus is accurate as of any date other than the date of this prospectus
  or that any information we have incorporated by reference is accurate as of any date other than the date of the document incorporated
  by reference regardless of the time of delivery of this prospectus or of any securities registered hereunder.
  i
  WHERE YOU CAN FIND
  MORE INFORMATION
  The
  Company is subject to the information requirements of the Securities Exchange Act of 1934, as amended (the "Exchange Act"),
  and, in accordance therewith, files reports, proxy statements and other information with the Commission. We are required to file electronic
  versions of those materials with the Commission through the Commission's EDGAR system. The Commission maintains an Internet site
  at http://www.sec.gov, which contains reports, proxy and information statements and other information regarding registrants that file
  electronically with the Commission. You can read and copy the reports, proxy statements and other information filed by the Company with
  the Commission at such Internet site.
  This
  prospectus constitutes part of a Registration Statement on Form S-8 filed on the date hereof (herein, together with all amendments and
  exhibits, referred to as the "Registration Statement") by the Company with the Commission under the Securities Act. This prospectus
  does not contain all of the information set forth in the Registration Statement, certain parts of which we have omitted, in accordance
  with the rules and regulations of the Commission. You should refer to the full Registration Statement for further information with respect
  to the Company and our Common Stock.
  Statements
  contained herein concerning the provisions of any contract, agreement or other document are not necessarily complete, and in each instance
  reference is made to the copy of such contract, agreement or other document filed as an exhibit to the Registration Statement or otherwise
  filed with the Commission. Each such statement is qualified in its entirety by such reference. Copies of the Registration Statement together
  with exhibits may be inspected at the offices of the Commission as indicated above without charge and copies thereof may be obtained therefrom
  upon payment of a prescribed fee.
  No
  person is authorized to give any information or to make any representations, other than those contained in this prospectus, in connection
  with the offering described herein, and, if given or made, such information or representations must not be relied upon as having been
  authorized by the Company or any Selling Stockholder. This prospectus does not constitute an offer to sell, or a solicitation of an offer
  to buy, nor shall there be any sale of these securities by any person in any jurisdiction in which it is unlawful for such person to make
  such offer, solicitation or sale. Neither the delivery of this prospectus nor any sale made hereunder shall under any circumstances create
  an implication that the information contained herein is correct as of any time subsequent to the date hereto.
  ii
  PROSPECTUS SUMMARY
  The Commission allows us to ''incorporate
  by reference'' certain information that we file with the Commission, which means that we can disclose important information
  to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus, and
  information that we file later with the Commission will update automatically, supplement and/or supersede the information disclosed in
  this prospectus. Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus shall
  be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus or
  in any other document that also is or is deemed to be incorporated by reference in this prospectus modifies or supersedes such statement.
  Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
  You should read the following summary together with the more detailed information regarding our company, our Common Stock and our financial
  statements and notes to those statements incorporated herein by reference.
  Our Company
  We are a biotechnology company focused on the research
  and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique molecular
  properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines. Our lead influenza
  (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties that enables
  the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and long-term immunity.
  We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines to improve both health
  outcomes and quality of life globally.
  Our pipeline includes novel vaccine candidates exclusively
  licensed from renowned research institutions. We seek to develop vaccines that provide long-lasting immunity to harmful viral and bacterial
  pathogens that cause infections in patient populations with high unmet needs. Our exclusive license agreements include patented influenza
  epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered by
  Dr. Sunetra Gupta and her team at the University of Oxford. Our collaborators are pioneers in vaccine discovery and development.
  We are exploring the development of these influenza ELV's utilizing our Norovirus shell and protrusion (S&P) nanoparticle vaccine
  platform licensed from Cincinnati Children's Hospital Medical Center, or CHMC. We are also utilizing our platform to develop
  a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus. Our exclusively licensed
  S. pneumoniae
  vaccine
  candidate is from St. Jude Children's Research Hospital. The vaccine is designed to prevent harmful middle-ear infections in children
  and is being developed for intranasal delivery, well suited for pediatric patients. We leverage the expertise of our collaborators to
  pursue the discovery and development of vaccines for these diseases, which are high unmet needs globally.
  In addition, we have expertise in identifying business
  development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion and the
  ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There is
  potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.
  Vaccination has been used as an effective method
  of protecting individuals against harmful diseases by utilizing the body's natural defense system to develop resistance or immunity
  to infections (World Health Organization,
  https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19
  ). The body's
  immune system naturally creates antibodies and cell -mediated immunity to defend against foreign pathogens. Vaccines introduce or present
  these foreign pathogens, prompting the body's immune system produce a response protective against the pathogen without exposing
  the body to the relevant lethal or harmful infection (World Health Organization,
  https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19
  ).
  While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to shortcomings
  of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to the current standards
  of care by harnessing durable and long-lived immune response to specific or multiple antigens.
  1
  The global vaccine market has recently experienced
  significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
  by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
  immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.
  As such, market research professionals project the
  global vaccine market size to reach $73.78 billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
  prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.
  This market acceleration has been coupled with various
  strategic transactions in the sector, including consolidations and mergers and acquisitions in recent years. Major market participants
  have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings. For instance,
  in February 2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines across the
  globe. Additionally, in October 2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired PaxVax
  for $270 million, and in July 2017 Sanofi acquired Protein Sciences for $650 million. The appetite of these companies to
  buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
  and worldwide.
  The U.S. Centers for Disease Control, or CDC,
  its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations for
  both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
  vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
  obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
  adoption.
  Pipeline
  Our vaccine candidates are being developed in a
  manner that is scalable, designed to be cost-effective and provide long-term benefit to patients from infectious agents.
  Our Vaccine Platform
  BWV Norovirus (NoV) S&P Nanoparticle Versatile Vaccine Platform
  Our Approach to Stimulating the Immune System for Infectious Disease
  Protection
  Our S&P platform was co-invented by two researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children's Hospital Medical
  Center. The pre-clinical research conducted at CHMC provided encouraging data that we believe supports investigation and development of
  the platform for our vaccine candidates. The S&P platform combines two or more immunogenic components, a norovirus antigen plus at
  least one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity.
  2
  Key Elements of our Platform
  We are leveraging our disruptive norovirus nanoparticle
  platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:
  ●
  Flexible and Scalable discovery platform engine.
  We
  believe we are able to design and create novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform's
  adaptability, we may opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as
  well as therapeutics.
  ●
  Cost-effective and Rapid Production of Novel Vaccines.
  We
  are potentially able to reduce the cost and time to manufacture a vaccine candidate by utilizing an
  E.coli
  expression platform,
  compared to traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells.
  We have bioengineered these nanoparticles to be stable and effective, determined through animal immunogenicity studies, using
  E.coli
  expression, which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system (Pharmaceutics
  2019, 11, 472; doi:10.3390/pharmaceutics11090472).
  ●
  Multi-antigen and Pathogen Capabilities.
  The
  power of our platform is its ability to carry multiple antigens at a time, thereby creating a multi-targeted vaccine. It also provides
  the opportunity to develop vaccines for protection against not only viral pathogens, but also bacterial, parasitic and fungal pathogens.
  ●
  Therapeutic potential.
  We believe
  our platform may offer opportunities to develop non-infectious disease therapeutic products, for example, being used as a carrier or
  vehicle to transport drugs to specific target locations.
  Our Vaccine Candidates
  BWV-101 and BWV-102: Influenza vaccine program
  Our lead vaccine program is focused on developing
  a transformational novel universal influenza vaccine, BWV-101. This program is licensed from the University of Oxford, where all relevant
  studies were performed to support our hypothesis. We are developing a broad-spectrum vaccine using patented epitopes of limited variability,
  or ELV, that provide cross reactive immune response to multiple historical flu strains. Additionally, based upon the successful pre-clinical
  proof-of-concept (POC) of our H1 epitopes, we are developing a stand-alone H1 influenza vaccine, BWV-102, to provide a long-lasting induced
  immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1, H3 and influenza
  B. Data in mice models have demonstrated proof of concept of neutralization against historical and current H1 strains, which includes
  annual and pandemic strains. This would negate annual flu shots, reformulation and potentially provide protection against future influenza
  pandemics. (Thompson et al. Nature Communications. 2018. 9:385).
  BWV-201: Streptococcus pneumoniae (S. pneumoniae) vaccine program
  We are developing BWV-201, licensed from St. Jude
  Children's Research Hospital, to prevent Acute Otitis Media, or AOM, in children and adults, a leading cause of hospital visits,
  prescription antibiotics and potentially permanent hearing loss. AOM due to
  S. pneumoniae
  infections range from 30 to 50% of all
  AOM infections each year (Monsata 2012 2012; 7(4): e36226). BWV-201 is a live attenuated serotype-independent intranasal vaccine candidate
  for
  S. pneumoniae
  induced AOM.
  BWV-301: Norovirus-rotavirus vaccine program
  We are developing a norovirus-rotavirus vaccine,
  BWV-301, to prevent gastroenteritis utilizing our S&P platform. Preclinical data from gnotobiotic pig studies have shown our vaccine
  can prevent severe gastroenteritis and reduces viral shedding. While rotavirus vaccines exist in the market, no norovirus vaccine is available
  to date. Our vaccine would protect people from two of the most globally prevalent viruses causing vomiting and diarrhea.
  3
  BWV-302: Norovirus-malaria vaccine program
  Additionally, we are currently investigating a malaria vaccine, BWV-302,
  utilizing our norovirus S&P platform. The vaccine is designed to offer protection from both norovirus and malaria, infectious diseases
  that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of the plasmodium parasite
  being presented on the surface of the norovirus nanoparticle.
  Corporate Information
  We
  were incorporated in Delaware on October 26, 2018. Our principal executive offices are located at 201 E. Fifth Street,
  Suite 1900, Cincinnati, Ohio 45202, and our telephone number is (513) 620-4101. Our corporate website
  address
  is
  www.bluewatervaccines.com
  . The information contained on or accessible through our website is not a part of this prospectus, and
  the inclusion of our website address in this prospectus is an inactive textual reference only.
  The Offering
  Outstanding Common Stock:
  12,229,399 shares of our Common Stock are outstanding as of June 24,
  2022.
  Common Stock Offered:
  Up to 1,600,000 shares of Common Stock for sale by the Selling Stockholders (which include our employees, consultants, executive officers and directors) for their own account pursuant to the 2019 Plan and the 2022 Plan.
  Selling Stockholders:
  The Selling Stockholders are set forth in the section entitled "Selling Stockholders" of this reoffer prospectus on page 106. The amount of securities to be offered or resold by means of the reoffer prospectus by the designated Selling Stockholders may not exceed, during any three month period, the amount specified in Rule 144(e).
  Use of proceeds:
  We will not receive any proceeds from the sale of our Common Stock by the Selling Stockholders. We would, however, receive proceeds upon the exercise of the stock options by those who receive options under the Plan and exercise such options for cash. Any cash proceeds will be used by us for general corporate purposes.
  Risk Factors:
  The securities offered hereby involve a high degree of risk. See "Risk Factors."
  Nasdaq Capital Market trading symbol:
  BWV
  4
  INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
  We
  are "incorporating by reference" in this prospectus certain documents we file with the Commission, which means that we can
  disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
  is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
  by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
  in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
  differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
  are incorporated herein by reference as of their respective dates of filing.
  (i)
  our Annual Report on
  Form 10-K
  for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;
  (ii)
  our Quarterly Report on
  Form 10-Q
  for the quarter ended March 31, 2022 as filed with the SEC on May 13, 2022;
  (iii)
  our Current Report on
  Form 8-K/A
  dated March 4, 2022, our Current Report on
  Form 8-K
  dated March 22, 2022; our Current Report on
  Form 8-K
  dated April 19, 2022; our Current Report on
  Form 8-K
  dated April 20, 2022; our Current Report on
  Form 8-K
  dated April 20, 2022; our Current Report on
  Form 8-K
  dated April 21, 2022; our Current Report on
  Form 8-K
  dated May 25, 2022;  our Current Report on
  Form 8-K
  dated June 1, 2022; and our Current Report on
  Form 8-K
  dated June 24, 2022.
  (iv)
  the description of our securities registered under Section 12 of the Exchange Act as filed as
  Exhibit 4.2
  on Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.
  All documents that we file
  with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
  indicates that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold,
  will be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.
  Any statement contained in
  a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
  for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
  also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
  superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
  of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
  furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
  by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
  to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
  incorporated by reference.
  You may request, orally or in writing, a copy of these documents, which
  will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated by reference), by contacting
  Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our telephone number is (513)
  620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However, the information on our website
  is not a part of this prospectus and is not incorporated by reference.
  5
  CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
  AND INDUSTRY AND MARKET DATA
  Special Note Regarding Forward-Looking Statements
  This prospectus contains forward-looking statements
  that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections titled "Prospectus
  Summary," "Risk Factors" and "The Company," but are also contained elsewhere in this prospectus. In some
  cases, you can identify forward-looking statements by the words "may," "might," "will," "could,"
  "would," "should," "expect," "intend," "plan," "objective," "anticipate,"
  "believe," "estimate," "predict," "project," "potential," "continue"
  and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future,
  although not all forward-looking statements contain these words. These statements relate to future events or our future financial performance
  or condition and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity,
  performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These forward-looking
  statements include, but are not limited to, statements about:
  ●
  our projected financial position and estimated cash burn
  rate;
  ●
  our estimates regarding expenses, future revenues and capital
  requirements;
  ●
  our ability to continue as a going concern;
  ●
  our need to raise substantial additional capital to fund
  our operation;
  ●
  the success, cost and timing of our clinical trials;
  ●
  our dependence on third parties in the conduct of our clinical
  trials;
  ●
  our ability to obtain the necessary regulatory approvals
  to market and commercialize our product candidates;
  ●
  the ultimate impact of the ongoing COVID-19 pandemic, or
  any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a
  whole;
  ●
  the potential that results of pre-clinical and clinical trials
  indicate our current product candidates or any future product candidates we may seek to develop are unsafe or ineffective;
  ●
  the results of market research conducted by us or others;
  ●
  our ability to obtain and maintain intellectual property
  protection for our current product candidates;
  ●
  our ability to protect our intellectual property rights and
  the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights;
  ●
  the possibility that a third party may claim we or our third-party
  licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial
  costs and be required to devote substantial time defending against claims against us;
  6
  ●
  our reliance on third parties;
  ●
  the success of competing therapies and products that are
  or become available;
  ●
  our ability to expand our organization to accommodate potential
  growth and our ability to retain and attract key personnel;
  ●
  the potential for us to incur substantial costs resulting
  from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization
  of our product candidates;
  ●
  market acceptance of our product candidates, the size and
  growth of the potential markets for our current product candidates and any future product candidates we may seek to develop, and our
  ability to serve those markets; and
  ●
  the successful development of our commercialization capabilities,
  including sales and marketing capabilities.
  These forward-looking statements are subject to
  a number of risks, uncertainties and assumptions, including those described in "Risk Factors." Moreover, we operate in a very
  competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all
  risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause
  actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties
  and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ
  materially and adversely from those anticipated or implied in the forward-looking statements.
  You should not rely upon forward-looking statements
  as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
  we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking
  statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for
  the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements
  for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations.
  You should read this prospectus and the documents
  that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus forms
  a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially
  different from what we expect.
  7
  THE COMPANY
  Overview
  We are a biotechnology company focused on the
  research and development of transformational vaccines to prevent infectious diseases worldwide. Our versatile vaccine platform has unique
  molecular properties that enables delivery of various antigens, which can be utilized to develop singular or multi-targeted vaccines.
  Our lead influenza (flu) vaccine program uses proprietary technology to identify specific epitopes, or proteins, with cross-reactive properties
  that enables the potential development of a universal flu vaccine. We are focused on developing novel vaccines that induce durable and
  long-term immunity. We believe that our pipeline and vaccine platform are synergistic for developing next generation preventive vaccines
  to improve both health outcomes and quality of life globally.
  Our pipeline includes novel vaccine candidates
  exclusively licensed from renowned research institutions. We seek to develop vaccines that provide long-lasting immunity to harmful viral
  and bacterial pathogens that cause infections in patient populations with high unmet needs. Our exclusive license agreements include patented
  influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered
  by Dr. Sunetra Gupta and her team at the University of Oxford. Our collaborators are pioneers in vaccine discovery and development.
  We are exploring the development of these influenza ELV's utilizing our Norovirus shell and protrusion (S&P) nanoparticle vaccine
  platform licensed from Cincinnati Children's Hospital Medical Center, or CHMC. We are also utilizing our platform to develop
  a vaccine for the prevention of gastroenteritis cause by both norovirus and rotavirus. Our exclusively licensed S. pneumoniae vaccine
  candidate is from St. Jude Children's Research Hospital. The vaccine is designed to prevent harmful middle-ear infections in children
  and is being developed for intranasal delivery well suited for pediatric patients. We leverage the expertise of our collaborators to pursue
  the discovery and development of vaccines for these diseases, which are high unmet needs globally.
  In addition, we have expertise in identifying
  business development opportunities for our platform vaccines technologies and portfolio. This allows for both internal pipeline expansion
  and the ability to generate non-dilutive revenue from potential licensing partners to utilize our discovery engine vaccine platform. There
  is potential for adjunctive or next generation therapeutic exploration to enhance current standard of care options.
  Vaccination has been used as an effective method
  of protecting individuals against harmful diseases by utilizing the body's natural defense system to develop resistance or immunity
  to infections (World Health Organization,
  https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19
  ). The body's
  immune system naturally creates antibodies and cell mediated immunity to defend against foreign pathogens. Vaccines
  introduce or present these foreign pathogens, prompting the body's immune system produce a response protective against the pathogen
  without exposing the body to the relevant lethal or harmful infection (World Health Organization,
  https://www.who.int/news-room/q-a-detail/herd-immunity-lockdowns-and-covid-19
  ).
  While vaccines are generally able to provide resistance against disease, many infectious diseases can evolve or mutate leading to shortcomings
  of traditional vaccines, such as yearly reformulations. We believe our vaccine candidates can provide an alternative to the current standards
  of care by harnessing durable and long-lived immune response to specific or multiple antigens.
  The global vaccine market has recently experienced
  significant growth caused by rising awareness of the importance of immunization and vaccination benefits in emerging markets as well as
  by projects to fuel further global market expansion. For instance, The World Health Organization (WHO) has undertaken initiatives to increase
  immunization awareness through its Global Vaccine Action Plan and Global Immunization Vision and Strategy.
  As such, market research professionals project
  the global vaccine market size to reach $73.78 billion by 2028, representing a CAGR of 7.3% over the forecast period, driven by rising
  prevalence of infectious diseases, increasing government funding for vaccine production and growing emphasis on becoming immunized.
  This market acceleration has been coupled with
  various strategic transactions in the sector, including consolidations and mergers and acquisitions in recent years. Major market
  participants have strategically acquired start-ups and mid-sized companies to broaden their products portfolios and service offerings.
  For instance, in February 2019, Bharat Biotech acquired Chiron Behring Vaccines, one of the leading manufacturers of rabies vaccines
  across the globe. Additionally, in October 2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired
  PaxVax for $270 million, and in July 2017 Sanofi acquired Protein Sciences for $650 million. The appetite of these companies
  to buttress their vaccine programs and pipelines reflects the increasing importance of vaccines in the healthcare sector, both nationally
  and worldwide.
  8
  The U.S. Centers for Disease Control, or
  CDC, its Advisory Committee on Immunization Practices, or ACIP, and similar international advisory bodies develop vaccine recommendations
  for both children and adults. New pediatric vaccines that receive ACIP preferred recommendations are almost universally adopted, and adult
  vaccines that receive a preferred recommendation are widely adopted. We believe that our vaccine candidates will be well-positioned to
  obtain these preferred recommendations, by virtue of their longer and more durable immunity, which could drive rapid and significant market
  adoption.
  PIPELINE
  Our vaccine candidates are being developed in
  a manner that is scalable, designed to be cost-effective and provide long term benefit to patients from infectious agents.
  Strategy
  We aim to identify, discover and develop novel
  preventive vaccines for infectious diseases. Key elements of our strategy include:
  ●
  Investment in advancing the development of our novel vaccine
  pipeline programs through IND-enabling activities and Phase I clinical studies.
  ●
  We plan to advance our main vaccine programs: influenza,
  S.
  pneumoniae
  induced AOM norovirus-rotavirus, and norovirus-malaria.
  ●
  Our in-licensed vaccine candidates are carefully selected
  based on the following criteria: area of significant unmet medical need for preventive long-term vaccine; strong scientific rationale
  and established clinical and regulatory pathways; defined competitive landscape and potential future commercial opportunity; and license
  exclusivity.
  ●
  Prioritizing the research and development for our lead
  influenza vaccine candidates, BWV-101 and BWV-102 through Phase I.
  ●
  Our goal is to develop a universal influenza vaccine that
  protects against all strains of influenza, including pandemic strains. In collaboration with The University of Oxford and CHMC, we are
  evaluating vaccine candidates to pursue the best development path forward to stimulate durable and broad-spectrum immunogenicity.
  ●
  We will leverage the pre-clinical and clinical experience
  we gain from the development of BWV-102 to accelerate the development of the BWV-101 program. We expect that the manufacturing and clinical
  data collected will provide invaluable insight for development of the universal vaccine candidate.
  ●
  Maximize and utilize the value of our collaborators and
  third-party vendors.
  ●
  We will combine disciplined business strategies to further
  expand the potential synergies with current collaborators.
  ●
  Deploy and expand our proprietary norovirus S&P nanoparticle
  platform.
  ●
  Our immunogenic multi-purpose vaccine platform technologies
  can be utilized with an array of infectious disease agents to access multiple development pathways and allow for potential next-generation
  life cycle management to expand our pipeline and pursue business development opportunities. There is potential for the platform to pursue
  adjunctive therapies to currently available drugs, and for current therapies to be re-optimized and formulated to protect against multiple
  antigens.
  9
  Management and History
  Blue Water Vaccines Inc. was founded in October 2018
  by our Chief Executive Officer, or CEO, Joseph Hernandez, with the initial goal of developing a transformational universal flu vaccine
  to treat and prevent infections in patients globally. Our initial technology, licensed from the University of Oxford, provides a novel
  approach to developing a universal influenza vaccine. Subsequently, our team has identified other program candidates and technologies
  to broaden and diversify our vaccine pipeline.
  Mr. Hernandez, our Chairman and CEO, is a
  veteran entrepreneur, philanthropist, and operator with a broad skillset of founding, building, and selling companies, as well as executing
  business development transactions and securing private and public capital, including Digene, Noachis Terra and Blue Water Acquisition
  Corp. Mr. Hernandez was responsible for our initial $7 million seed funding round from investors including CincyTech. In addition
  to his position as our Chairman and CEO, Mr. Hernandez also serves on the board of directors for Clarus Therapeutics, Inc. (Nasdaq:
  CRXT) in addition to certain other private companies. Subsequently, a team of veteran industry executives and advisors were assembled,
  bringing valuable expertise to our growing infectious disease company.
  Jon Garfield, our Chief Financial Officer, has
  over 20 years of financial leadership experience, including with healthcare companies. Mr. Garfield regularly provides consulting
  services to private equity funds and privately held companies and has served as the CEO of Unity MSK since February 2021, and served
  as interim Chief Financial Officer of Blue Water Vaccines Inc. from September 2021 until the consummation of our initial public offering
  in February 2022, upon which he became our full-time Chief Financial Officer. Erin Henderson, who serves as our Chief Business Officer
  and Corporate Secretary, has over 20 years of leading strategic transactions, governmental and stakeholder relations and corporate
  expansion. Previously, since 2010, she was the Managing Principal at The Aetos Group, a management consulting firm serving both the public
  and private sectors. Andrew Skibo is our Head of Biologic Operations and was recently Head of Global Biologics Operations at MedImmune/AstraZeneca
  and previously worked for Amgen and Genentech (now Roche), where he was responsible for operations, engineering, construction, and validation
  for large-scale capital projects related to bio-pharmaceutical manufacturing. Ronald Cobb, Ph.D., our Head of Science and Discovery, was
  recently Chief Scientific Officer at Ology Bioservices (formerly Nanotherapeutics) and previously worked for RTI Biologics and Berlex
  Biosciences. Brian Price, Ph.D., our Head of Technology Strategy, brings over 20 years of successful product development experience
  and business development growth based on programs in toxicology, analytics, and therapeutic and vaccine development.
  Additionally, members of our Board of Directors
  have extensive expertise in the fields of life sciences, business, and finance. In addition to Mr. Hernandez, our directors include
  Michael Venerable, CEO of CincyTech, Kimberly Murphy, former VP, Commercialization Leader, influenza at GlaxoSmithKlein, President, CEO
  and Director of Oragenics, Inc. (Nasdaq: OGEN) and Chair of Clarus Therapeutics (Nasdaq: CRXT), Allan Shaw, an experienced biotechnology
  CFO, and James Sapirstein, R.Ph., M.B.A, President, CEO and Chairman of First Wave BioPharma, Inc. (Nasdaq:FWBI). Our Scientific Advisory
  Board includes Sunetra Gupta, Ph.D. Professor of Theoretical Epidemiology at The University of Oxford, a leading voice in infectious
  disease globally; David Zarley, Ph.D., with more than 30 years of experience in vaccine research and development, including former
  leadership roles at Pfizer and Wyeth; and John Rice, Ph.D., Managing Director at CincyTech, with more than 30 years of biotechnology
  advising experience.
  Subject to certain non-compete restrictions, our
  chief executive officer, Joseph Hernandez, and other key personnel may pursue other business or investment ventures while employed with
  us. Accordingly, they may have conflicts of interest in allocating time among various business activities and potentially competitive
  fiduciary and pecuniary interests that conflict with our interests. See "Risk Factors — Our Chief Executive Officer,
  Joseph Hernandez and our Chief Financial Officer, Jon Garfield, hold certain management positions and directorships of other companies
  and may allocate their time to such other businesses, which may cause conflicts of interest in their determination as to how much time
  to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests." Any such
  additional business activities or ventures may present conflicts to our interests. We do not believe that any such potential conflicts
  would materially affect our ability to conduct our operations.
  10
  Our Vaccine Platform
  BWV Norovirus (NoV) S&P Nanoparticle Versatile Vaccine Platform
  Bioengineering the shell (S) and protruding
  (P) domains of the norovirus capsid protein, polyvalent nanoparticles and polymers/oligomers provide a versatile vaccine platform
  with wide applications
  Our Approach to Stimulating the Immune System
  for Infectious Disease Protection
  Our S&P platform was co-invented by two researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., of the Division of Infectious Disease at the Cincinnati Children's Hospital Medical
  Center. The pre-clinical research conducted at CHMC provided encouraging data that supports further investigation and development of the
  platform for our vaccine candidates. The S&P platform combines two or more immunogenic components, a norovirus antigen plus at least
  one additional antigen, together creating novel constructs. The norovirus nanoparticle enhances immunogenicity of the inserted antigen.
  The S & P particles themselves also act as antigens, and are large enough to trigger an immune response to a foreign substance.
  By combining the norovirus nanoparticle with one or more antigens from other infectious disease(s), the immune system is stimulated to
  create antibodies to both the norovirus and the additional antigen(s).
  Key Elements of our Platform
  We are leveraging our disruptive norovirus nanoparticle
  platform to develop novel, broad-spectrum vaccines for adult and child infectious disease prevention by taking advantage of:
  ●
  Flexible and Scalable discovery platform engine.
  We
  believe we are able to design and create novel vaccines that are stable and scalable for broad spectrum prophylactics. Through this platform's
  adaptability, we may opportunistically expand our pipeline and potentially collaborate with third parties for additional vaccines, as
  well as therapeutics.
  ●
  Cost-effective and Rapid Production of Novel Vaccines.
  We are potentially able to reduce the cost and time to manufacture a vaccine candidate by utilizing an E.coli expression platform,
  compared to traditional vaccine production which uses other, longer production-time platforms, such as Chinese Hamster Ovary (CHO) cells.
  We have bioengineered these nanoparticles to be stable and effective, as determined through animal immunogenicity studies, using
  E.coli
  expression which may provide cost savings and efficiency compared to other VLPs needing a eukaryotic expression system. (Pharmaceutics
  2019, 11, 472; doi:10.3390/pharmaceutics11090472).
  ●
  Multi-antigen and Pathogen Capabilities.
  One of the
  key features of our platform is its ability to carry multiple antigens at a time, thereby creating a multi-targeted vaccine. It also
  provides the opportunity to develop vaccines for protection against not only viral pathogens, but also bacterial and potentially parasitic
  and fungal pathogens.
  ●
  Therapeutic potential.
  We believe our platform may
  offer opportunities to develop non-infectious disease therapeutic products, for example being used as a carrier or vehicle to transport
  drugs to specific target locations.
  Viral capsid proteins are responsible for many
  basic functions necessary for viral life cycles, such as viral attachment and entry, and thus can elicit neutralizing antibodies against
  viral infection after immunization to humans and animals. Consequently, viral capsid proteins are promising vaccine targets against viral
  infection. Indeed, various capsid protein nanoparticles and complexes have been developed and used as nonreplicating subunit vaccines
  to combat various infectious diseases.
  11
  Unlike traditional live-attenuated and inactivated
  virus vaccines that need cultivation of infectious virions and are associated with certain safety concerns, the nonreplicating VLP vaccines
  derived from bioengineered viral capsid proteins do not involve an infectious agent and, therefore, may be safer and have lower manufacturing
  costs than traditional vaccines. Thus, VLP vaccines represent a next generation of innovative vaccine strategy.
  Structure
  ●
  The NoV (VP1) capsid structure consists of two major domains:
  (i) a N-terminal shell (S) domain and (ii) a C-terminal protruding (P) domain. The S domain builds the interior shell of the
  capsid and the P domain forms the dimeric protrusions of the capsid.
  ●
  The protrusions (P) of norovirus capsid interact with
  viral glycan receptors for attachment to host cells to initiate an infection.
  ●
  The S domain interacts homotypically and drives self-formation
  of an approximately 60 nm VLP.
  ●
  The P domain exhibits homotypic interactions, forming a 24
  nm VLP with dimeric protrusions for stabilization of the viral capsid. Additionally, it can also form oligomers or polymers.
  Figure 1.
  Lineage structures of norovirus
  capsid protein or viral protein 1 (VP1) and various nanoparticles derived from full-length or truncated VP1. The N-terminal shell (S) (green)
  and the C-terminal protruding (P) (dark blue) domains with a short flexible hinge (light blue) in between (with amino acid numbers
  based on GI.1 Norwalk virus VP1) are shown. (A) Production of full-length norovirus VP1s via a eukaryotic expression system self-assembles
  into virus-like particles (VLPs). (B) Production of the S or P domain via the
  Escherichia coli
  expression system self-assembles
  into S or P nanoparticles.
  12
  Due to the homotypic interaction attributed to
  the norovirus capsid domains, researchers at CHMC, through bioengineering, designed and generated two subviral nanoparticles, the 24-valent
  P
  24
  and the 60-valent S
  60
  nanoparticles, and P-derived polymers to serve as a multifunctional vaccine platform against
  different pathogens and illnesses.
  ●
  These nanoparticles and polymers are easily produced, highly
  stable, and extremely immunogenic which we believe makes them compelling platforms to serve to display foreign antigens, self-assembling
  into chimeric nanoparticles or polymers as vaccine candidates.
  ●
  There are several preclinical studies that showed P
  24
  /S
  60
  chimeric vaccine candidates that can display different foreign antigens and epitopes, as set forth below in Tables 1 and 2. Therefore,
  there may be additional candidates to further explore as human vaccines.
  (Xia et al. ACS Nano 2018, 12, 10665−10682)
  .
  ●
  Such VLPs and capsid-like nanoparticles may be excellent
  vaccine candidates against corresponding viral pathogens because they can retain arrays of antigenic epitopes that faithfully mimic those
  of the native virions, and these repeated viral antigens and epitopes stimulate strong immune responses in their animal and human hosts.
  In addition, such highly immunogenic subviral nanoparticles may also serve as versatile platforms that are able to display foreign antigens
  for improved immune responses to facilitate development of novel vaccines against various pathogens and diseases.
  ●
  The fact that the P
  24
  VLP nanoparticles and polymers
  are composed of authentic norovirus antigens and retain norovirus-specific molecular patterns make it an excellent vaccine candidate
  against the norovirus.
  ●
  In addition, the natures of self-formation, high stability,
  polyvalence, and high immunogenicity, as evidenced by animal studies conducted in gnotobiotic pig models and mouse models, results included
  herein, of the nanoparticles and polymers make them strong vaccine candidate platforms to display foreign antigens, resulting in chimeric
  nanoparticles as vaccine candidates against further pathogens and diseases.
  Our multifunctional vaccine platform is a robust
  discovery engine and has broad application using both S
  60
  and P
  24
  nanoparticles to target multiple pathogens and
  illnesses.
  The P
  24
  nanoparticle has also been
  used to display multiple viral epitopes for enhanced immunogenicity for novel subunit vaccine development, see Table 1 below. These include
  the M2e epitope of the matrix 2 (M2) protein and the HA2 protein B cell epitope of influenza viruses, the B cell epitope of VP3 of enterovirus
  71 (EV71), the 4E10 and 10E8 epitopes of human immunodeficiency virus type 1 (HIV-1), among others.
  Table 1. Summary of norovirus nanoparticles and polymers as vaccine
  candidates and platforms to display foreign antigens and epitopes.
  Nanoparticle/ Polymer
  Antigen/Epitope to be Displayed (Pathogen)
  Chimeric Products as
  Vaccine Candidate
  Immunity against
  Pathogens or Diseases
  S
  60
  VP8* (rotavirus)
  S
  60
  – VP8*
  Rotavirus
  P
  24
  P domain (norovirus)
  P
  24
  Norovirus
  P
  24
  VP8* (rotavirus)
  P
  24
  – VP8*
  Rotavirus and norovirus
  P
  24
  M2e (influenza virus)
  P
  24
  – M2e
  Influenza virus
  P
  24
  HA2 B cell epitope
  (influenza virus)
  Trivalent HA2-PP (P
  24
  -HA2:90-105)
  Influenza A virus and influenza B virus
  P
  24
  VP3 B cell epitope (EV71)
  PP-71-6 (P
  24
  -71-6)
  EV71
  P
  24
  4E10/10E8 epitopes (HIV-1)
  4E10-PP/10E8-PP
  HIV-1
  P
  24
  Amyloid-beta, Aβ
  PP-3copy-Aβ1-6
  Alzheimer's disease
  P polymer
  P domains (noroviruses)
  NoV P
  GI
  -NoV P
  GII
  GST NoV P
  +
  Different noroviruses
  P polymer
  P domain (HEV)
  NoV P-HEV P
  Norovirus and HEV
  P polymer
  P domain (astrovirus) P domain (HEV)
  Ast P-HEV P-NoV P
  Norovirus, astrovirus,
  and HEV
  P polymer
  P domain (astrovirus) P domain (HEV)
  VP8* (rotavirus)
  Ast P-HEV P-VP8*
  Rotavirus, astrovirus,
  and HEV
  Note: EV71, enterovirus 71; HIV-1, human immunodeficiency virus type
  1; HEV, hepatitis E virus; Ast, astrovirus, NoV, norovirus, P, protruding domain; P+, the P domain with an end-linked cysteine-containing
  peptide that can self-assemble into oligomers; PP, P particle; GI, norovirus genogroup I; GII, norovirus genogroup II. Please
  see the main text for details.
  13
  The S
  60
  Nanoparticle as a Multifunctional vaccine platform
  Recent technology has generated S nanoparticles
  using an
  E. coli
  system with stabilized expression and self-assembly. The S nanoparticles feature exposed C-terminal flexible hinge
  sites that offer ideal fusion sites for displaying foreign antigens.
  Researchers at CHMC have developed a technology
  to produce uniform 60-valent NoV S
  60
  nanoparticles with high efficiency using a simple bacterial expression system. This was
  achieved by taking advantage of the homotypic interactions of the NoVVP1 S domain that naturally builds the interior shells of NoV capsids,
  as well as several modifications to stabilize the S domain proteins and enhance the inter-S domain interactions, respectively. Specifically,
  we introduced an R69A mutation to destruct the exposed protease cleavage sites on the surface of the native shell that otherwise leads
  to easy degradation of the S proteins. In addition, we introduced triple (V57C/Q58C/S136'C) cysteine mutations to establish inter-S
  domain disulfide bonds between two pairs of sterically close residues that belong to two neighboring S domains. This led to significantly
  enhanced stability and yields of the self-assembled S
  60
  nanoparticles produced by the simple
  E. coli
  system. The below
  bullets are supported by published data by Ming Tan, the co-inventor of the S&P platform, and his research team at CHMC.
  ●
  An important feature of our technology was to rationally
  introduce intermolecular disulfide bonds to stabilize the S
  60
  nanoparticles. This approach could also be used to stabilize
  other viral protein particles or complexes.
  ●
  The 60 freely exposed C-termini are a key feature facilitating
  the S
  60
  nanoparticle to be a useful vaccine platform. Foreign antigens or epitopes can simply be fused to the end of the S
  domain via flexible linker through recombinant DNA technology.
  ●
  Uniform 60-valent NoV VLPs or S particles produced in a bacterial
  expression system have not been produced before.
  ●
  Importantly, our S
  60
  nanoparticles maintained
  the native conformation with authentic antigenicity; thus, our NoV S
  60
  nanoparticle technology represents a significant bioengineering
  advancement as uniform 60-valent NoV VLP or S particle
  via
  an expression system have never been produced before (Xia et al. ACS
  Nano 2018, 12, 10665−10682).
  ●
  Uniform complexity and size of vaccine particles are important
  factors in quality control of vaccine products, as variations in complexity and size will result in variations in immunization outcomes
  of the vaccines.
  Broad application to fuse several antigens to the S
  60
  nanoparticle based on multiple studies shown below conducted by CHMC (Xia et al. ACS Nano 2018, 12, 10665−10682)
  CHMC has been able to fuse several antigens to
  the S
  60
  nanoparticle to the same exposed S domain C-terminus via the same linker. These included (1) the rotavirus (RV)
  surface spike protein VP8*; (2) the HA1 antigen or receptor-binding domain (RBD) (223 amino acids) of the hemagglutinin (HA)
  of anH7N9 influenza A virus; (2) the TSR antigen (67 amino acids) of the circumsporozoite surface protein (CSP) of the malaria
  parasite Plasmodium falciparum; (3) the protruding domain antigen (187 amino acids) of a hepatitis E virus; (4) a longer
  version of the RV VP8*antigen (231 amino acids); and (5) the VP8*antigen (159 amino acids) of the murine RV (mRV) EDIM
  strain (Table 1). Particle formations of these fusion proteins have been shown by gel-filtration and/or EM (Table1). In addition, they
  have shown that the S
  60
  nanoparticle-displayed HA1 and mRV VP8*antigens elicited significantly higher HA1- and mRV VP8*-specific
  antibody titers, respectively, than those elicited by the free HA1 or mRV VP8*antigens (Table 2).
  14
  Table 2. List of Antigens That Have Been Displayed by the S
  60
  Nanoparticles
  epitope/antigen
  size
  (residue)
  yield (mg/L
  bacteria culture)
  S
  60
  – antigen
  particle
  formation
  significant
  immune
  enhancement
  in mice
  f
  RV VP8* antigen
  159
  ~40
  yes
  yes
  HA1 antigen
  a
  223
  ~10
  yes
  yes
  TSR/CSP antigen
  b
  67
  ~10
  yes
  ND
  full RV VP8* antigen
  c
  231
  ~20
  yes
  ND
  murine RV VP8* antigen
  d
  159
  ~5
  yes
  yes
  HEV protruding domain antigen
  e
  187
  ~10
  yes
  ND
  a
  HA1 antigen containing the receptor binding site is the head portion of the hemagglutinin (HA) of H7N9 influenza A virus.
  b
  TSR/CSP antigen is the C-terminal portion of the major surface protein of acircumsporozoite (CSP) that plays a key role in host cell invasion of the malaria parasite Plasmodium falciparum.
  c
  Full RV VP8*antigen is the full-length VP8*domain of the spike protein of a human P[8] rotavirus.
  d
  Murine RV VP8*antigen is the core portion of the VP8*protein constituting the head of the spike protein of a murine rotavirus EDIM strain.
  e
  HEV protruding domain antigen is part of the protruding domain of a hepatitis E virus capsid.
  f
  Immune enhancements of the S
  60
  nanoparticle-displayed antigens were measured in mice using free monomeric antigens as control for comparisons. "ND" = not determined.
  S
  60
  nanoparticles may serve as a polyvalent vaccine platform
  (Xia et al. ACS Nano 2018, 12, 10665−10682)
  ●
  We believe the self-assembled, polyvalent S
  60
  nanoparticle with 60 flexibly exposed S domain C-termini is an ideal vaccine platform for antigen presentation and immunogenicity enhancement.
  ●
  This has been supported by studies showing that when Hisx6
  tag was fused to the hinge of the S domain via a linker, fusion proteins self-formed into the S
  60
  nanoparticles.
  ●
  This has also been demonstrated by constructing a chimeric,
  and reconfirmed by cyroEM density map, S
  60
  nanoparticle displaying 60 RV (rotavirus) VP8* proteins, the major rotavirus neutralizing
  antigen. The S
  60
  -VP8*particles can be easily produced with high stability. The chimeric nanoparticle induced higher
  immunoglobulin, or IgG, response in mice (n=6) toward the displayed VP8*antigen than soluble VP8* antigen. Mouse sera experiments were
  completed analyzing vaccinated versus the control group to show neutralizing activity against RV infection. The statistical differences
  between the groups are (*P < 0.05, **P < 0.01, ***P < 0.001) as shown below (Figure 2) (Xia et al. ACS Nano 2018, 12, 10665−10682).
  ●
  The RV surface spike protein, VP8* was tested for feasibility
  of the S
  60
  nanoparticle by the analysis using EM micrograph examination and ESI-MS analysis. S
  60
  -VP8*particles
  exhibited stronger blockade in mice (n=6) sera after vaccination (P=0.0003) (Xia et al. ACS Nano 2018, 12, 10665−10682).
  ●
  The polyvalent B- and T-cell epitopes of the antigens on
  the polyvalent VLP platform led to induction of stronger humoral and cellular immune responses, respectively, in animals and humans compared
  with those elicited by the monovalent epitopes of the free antigen. Thus, the polyvalent VLP platform is likely to increase the immunogenicity
  of the displayed antigens. Mouse sera experiments were completed analyzing vaccinated versus the control group to show neutralizing activity
  against RV infection. The statistical differences between the groups are (*P < 0.05, **P < 0.01, ***P < 0.001) as shown below.
  (Xia et al. ACS Nano 2018, 12, 10665−10682).
  15
  Figure 2.
  S
  60
  -VP8*particles
  enhanced immunogenicity toward the displayed RV VP8*antigens. The same dose/dosage of the S
  60
  -VP8*particles, free VP8*antigens,
  and S
  60
  nanoparticles without VP8*was given to mice (N=6), respectively, followed by measurements of theVP8*-specific IgG responses
  (A), 50% blocking titers (BT50) against RV VP8*-glycan ligand interaction (B), and neutralization activity against RV infection/replication
  in culture cells (C) of the resulting mouse antisera. (A) VP8*-specific IgG responses/titers elicited by theS60-VP8*particles,
  free VP8*antigens, and the S60nanoparticles, respectively. (B) BT50against RV VP8*−ligand interactions by the mouse sera after
  vaccination with the same three immunogens, respectively. (C) Neutralizing activity against RV infection/replication in culture cells
  by mouse sera after immunization with the same three immunogens, respectively. In all these experiments mouse sera after immunization
  with diluent (PBS) are used as negative controls.
  16
  The P
  24
  Nanoparticle as a versatile platform (Tan et
  al. Nanomedicine, 2012. 7.6,1-9)
  The crystal structure of norovirus VLPs indicates
  that P domain is involved in strong dimeric interactions forming dimeric protrusions on the viral surface. The oligomeric interactions
  of the P domains are also observed at the five-fold axes to further stabilize the capsid structure. When the P domain protein was expressed
  using the
  E. coli
  system, it self-assembled into P dimers, as well as 24 valent P nanoparticles, P
  24
  . P dimers
  and P
  24
  nanoparticles can exchange dynamically, depending on concentration of the P domain protein, indication that the assembled
  P
  24
  particles at this stage were unstable and easy to disassemble back into P dimers. To facilitate P
  24
  nanoparticle
  formation, inter-P domain disulfide bonds were introduced through fusion of a cysteine-containing peptide to the end of the P domain.
  During the P
  24
  nanoparticle assembly, the cysteine patches were brought to the center of the P
  24
  nanoparticles,
  resulting in sterically close contact and thus forming inter-P domain disulfide bonds that significantly stabilized the P
  24
  nanoparticles, which could no longer disassemble back into the P dimers.
  ●
  P
  24
  nanoparticles can be produced using an
  E.
  coli
  expression system faster and a lower cost than VLPs.
  ●
  Both VLP and P
  24
  nanoparticles without adjuvant
  produce innate, humoral, and cellular immunity.
  ●
  The platform can be used to display foreign antigens, epitopes
  and viral pathogens and non-infectious disease.
  ●
  Studies have demonstrated immune response against flu, rotavirus,
  and norovirus using bi- or trivalent vaccine candidates developed using this approach, noting the potential for the development of a
  universal flu vaccine. Pre-clinical studies in influenza and rotavirus are provided below supporting our vaccine candidate programs.
  See —
  Our Infectious Disease Vaccine Candidates
  .
  Our Infectious Disease Vaccine Candidates
  Infectious diseases are one of the leading causes
  of death worldwide. Infectious disease is caused by microorganisms or pathogens, including viruses, bacteria, fungi, and parasites that
  infect an individual and cause disease. Diseases often cause high fever, inflammation, or other symptoms. While some diseases can be treated
  with drugs or therapeutics, some infectious agents evolve to become resistant to commonly used drugs, such as antibiotics, and can become
  difficult to control. Infectious diseases can be passed from person to person or transmitted by insects or other animals. In many cases,
  vaccines are used to elicit a protective immune response in the absence of an infection to render an individual immune to a particular
  infectious disease.
  BWV-101: UNIVERSAL INFLUENZA & BWV-102 H1 INFLUENZA
  The company's lead vaccine programs are
  focused on developing transformational and novel influenza vaccines: BWV-101 for an influenza vaccine to provide protection against H1,
  H3 and Flu B infections; and BWV-102 for a H1 only vaccine. This program is licensed from the University of Oxford in which all relevant
  studies were performed to support our hypothesis. Our goal is to develop a vaccine that protects against all influenza strains that commonly
  infect humans by targeting specific parts of the influenza viruses, which are of limited variability across flu strains and induce a strong
  protective immune response. This POC will be leveraged to develop BWV-101 by studying the cross-reactivity of different flu strains, H1,
  H3 and influenza B. The BWV-101 vaccine candidate may potentially provide a therapeutic benefit that negates the need for annual
  vaccination, vaccine reformulation, and provide long-lasting broad protection against the flu to millions globally (Thompson et al. Nature
  Communications. 2018. 9:385).
  17
  Influenza
  Influenza is a viral infection of the respiratory
  system, causing an infected person to suffer from certain symptoms, including fever, muscle aches, runny nose, cough, congestion, headaches,
  and fatigue. The four types of influenza viruses include type A, B, C, and D. The type A and B influenza viruses are referred to
  as human influenza viruses that are primarily responsible for seasonal flu epidemics each year. Type A flu viruses are further divided
  into two subtypes, named based on differences in two viral surface proteins called hemagglutinin (H) and neuraminidase (N).
  Influenza types C and D present a lower priority for vaccination, as Type C viruses cause a mild respiratory illness in humans and has
  not been associated with human epidemics, and Type D viruses primarily affect cattle and are not known to cause illness in humans (
  https://www.cdc.gov/flu/about/viruses/types.htm
  ).
  Figure 3.
  This graphic shows influenza
  virus types including the two types of influenza viruses (A,B) that cause most human illness and that are responsible for the flu season
  each year. Influenza A viruses are further classified into subtypes, while influenza B viruses are further classified into two lineages:
  B/Yamagata and B/Victoria.
  There is a major unmet need for the development
  of a novel universal flu vaccine as a prophylactic therapy. Influenza is a major respiratory pathogen. The WHO estimates there are an
  estimated 1 billion cases of influenza infection with 3-5 million severe cases and 290,000-650,000 related respiratory
  human deaths worldwide every year. The estimate does not take into account deaths from other diseases such as cardiovascular disease,
  which can be influenza related. The next influenza pandemic is believed by many experts to be a potentially devastating global health
  threat. Influenza mortality rates are highest for the very young and elderly.
  The global influenza vaccine market was valued
  at $3.96 billion in 2018, and is projected to reach $6.20 billion by 2026, representing a CAGR of 5.9% from 2019 to 2026. Currently,
  the standard of care and most effective protection against flu is through annual vaccination. The WHO estimates that worldwide, approximately
  $4 billion is spent on influenza vaccines annually. However, the flu also a major cause of work absenteeism, leading to an estimated
  annual productivity loss in the U.S. of $87 billion. Flu vaccination consists of a yearly injection of attenuated or inactivated
  (dead) influenza viruses to induce humoral immunity in the form of the antibodies against the current circulating or anticipated seasonal
  influenza strains. The induction of antibody-producing B-cells through vaccination allows the immune system to defend the body against
  the influenza virus circulating during the winter months.
  An annual seasonal flu vaccine is the best way
  to help protect against flu. Vaccination has been shown to have many benefits including reducing the risk of flu illnesses, hospitalizations
  and even the risk of flu-related death in children. The CDC recommends use of any licensed, age-appropriate influenza vaccine during the 2020-2021
  influenza season, including inactivated influenza vaccine (IIV), recombinant influenza vaccine (RIV), or live attenuated influenza vaccine
  (LAIV). No preference is expressed for any influenza vaccine over another. Both trivalent and quadrivalent influenza vaccines will be
  available. The trivalent vaccines formulation will include A(H1N1) pdm09, A(H3N2) and B/Victoria. The quadrivalent vaccine formulations
  will include A(H1N1) pdm09, A(H3N2) and B/Victoria, plus B/Yamagata (
  https://www.cdc.gov/flu/about/viruses/types.htm
  ).
  18
  The current influenza vaccines induce antibodies
  that target regions of the virus that are highly variable and have serious shortcomings, as they:
  (i)
  must be administered annually,
  (ii)
  typically provide protection to only 50% of the individuals
  who receive it; and
  (iii)
  need to be updated annually and reformulated 6 months
  prior to influenza season, such that strains that are subsequently prevalent during the applicable "flu season" are not protected
  against by the vaccine.
  Our Proprietary Epitope Discovery
  Using the technology that we have exclusively
  licensed from the University of Oxford, we are developing a universal influenza vaccine. Our exclusive license agreements include patented
  influenza epitopes of limited variability, or ELV, identified through a proprietary computational research and discovery process, discovered
  by Dr. Sunetra Gupta and her team at the University of Oxford. We have acquired intellectual property for cross-protective epitopes
  to be used for our vaccine candidates that were developed and identified through a unique computational discovery process at Oxford University.
  The data produced through computational analysis at Oxford has shown that antigen evolution in influenza is limited to certain regions
  of the virus that facilitate binding and entry to host cells and these regions of limited antigenic variability are naturally immunogenic
  and therefore may be used to develop universal immunity to influenza viruses. We have identified epitopes of limited variability in H1
  influenza that have circulated throughout history (since 1918) and make ideal vaccine targets and have completed similar analysis of H3
  and Flu B strains for similar epitopes which will be used to produce our lead vaccine candidate BWV-101 as a universal vaccine for influenza
  infection. Due to the cross-reactive nature of the H1 epitopes in pre-pandemic H1 influenza A, we are also pursuing the development of
  a stand-alone H1 vaccine (BWV-102). These epitopes are able to be formulated into a vaccine candidate using our VLP platform technologies
  and may be evaluated using other vaccine technologies through partnerships in order to accelerate development of potential vaccines or
  to explore adjunct therapies (Thompson et al. Nature Communications. 2018. 9:385).
  Figure 4.
  Current influenza vaccine targets.
  Antigenic Drift (Thompson et al. Nature Communications. 2018. 9:385)
  A single conformational epitope is typically 8
  to 15 amino acids in length and in an extreme circumstance (where every change creates an escape mutant), a single epitope could
  theoretically vary from 208 to 2015 different ways. Therefore, a highly variable virus like influenza should be able to mutate in countless
  ways during each subsequent season. This would inevitability lead to an explosion of genetic diversity and numerous circulating strains.
  19
  However, it seems that there is a constraint limiting
  how influenza evolves, leading to a single or limited number of strains dominating each season. In 2007, Sunetra Gupta led a group of
  researchers at the University of Oxford who published a proprietary mathematical model proposing that the single strain dominance, typically
  seen worldwide annually, could be explained by hypothesizing that epitopes of 'limited variability' exist (Antigenic Drift
  Hypothesis). The model hypothesizes that while there is a significant amount of mutation of influenza strains, this variability occurs
  in a specific portion of the virus, while certain epitopes are required to remain relatively constant and are more limited in their variability
  in order for the virus to infect individuals, thus clarifying how influenza is not as variable as commonly thought.
  Antigenic Drift Hypothesis Illustration
  Figure 5.
  Identification of a site of limited
  variability in the head domain of the H1 HA.
  b,c
  Location of ABS of lowest variability containing position
  147 with position 147 shown in yellow and the rest of the site colored in red.
  d
  Phylogenetic trees of pre-pandemic and post-pandemic highlighted
  rectangle H1N1with tips colored according to the conformation of the epitope of limited variability (hereafter called OREO). Please note
  the re-introduction of H1N1influenza in 1977 involved a strain which previously circulated in 1949/50.
  The Antigenic Drift Hypothesis suggests the existence
  of epitopes of limited variability mediate a population's immunity to influenza strains. As a particular influenza strain circulates
  in the population, immunity to a specific pattern of epitopes is induced. This leads the virus to change its antigenic configuration and
  cycle through its limited repertoire of antigenic conformations. However, population immunity also changes due to birth and death within
  the population (i.e. individuals in the population who had experienced and developed immunity to certain conformations die). This allows
  prior epitope conformations to reappear. The loss of herd immunity to these epitope of limited variability causes the emergence of epidemics
  (
  Thompson et al. Nature Communications. 2018. 9:385
  ).
  20
  Oxford scientists have identified the naturally
  antigenic regions that drive immunity to influenza by evaluating serum from these from various age groups of humans using assays and ELISAs
  reveal periodic cross-reactivity to ELV. Pseudotype microneutralisation data reveals a cyclical pattern of epitope recognition. The
  studies of children's sera were used to detect antibodies and demonstrated that young children ages 6 to 12 had immunity to historical
  influenza strains that circulated many years prior to when they were born and they could never have possibly been exposed to, one
  of which that last circulated in 1934. Mutagenesis of the identified regions of limited variability in various historical viruses removed
  the protective immunity. Furthermore, vaccination of mice, as shown below, with these regions of the influenza virus produced an identical
  immune response that was observed in the children. For example, the mice vaccinated with either the region from the influenza virus circulating
  in 2006 or 1977 were protected against infection with an influenza with a virus that last circulated in 1934, replicating the immunity
  seen in children ages 6 to 12. (Thompson et al. Nature Communications. 2018. 9:385)
  21
  Figure 6.
  Sequential vaccination using
  chimeric HA constructs. Five groups of mice were sequentially vaccinated with 2009-like (blue), 2006-like (red),1995-like (orange), 1977-like
  (green) and 1940-like (pink) epitope sequences substituted into H6, H5 and H11 Has. Two further control groups were sequentially vaccinated
  with H6, H5 and H11 constructs without any sequence substituted into the Has (vaccinated controls). Further two groups were mock vaccinated
  (unvaccinated controls).
  c,d,f,g
  Pseudotype microneutralisation assays using 0.5μl of sera from the bleed at 21 weeks.
  Error bars are mean ± s.e.m.n=6 for experimental groups and control groups. The values provided are an average of two replicates
  This work demonstrated that vaccination with just
  four variants of one region of limited variability in H1 influenza was able to elicit immunity to all historical H1 influenza strains.
  As these regions periodically reappear and disappear over time, vaccination with all of the possible variants would be expected to provide
  protection against future influenza strains as well. The identified epitopes are restricted in their variability due to presence of a
  receptor-binding site and small alpha helix structure between disulphide bonds.
  22
  The following research findings form the basis
  for our influenza vaccine candidates:
  1.
  Epitopes of limited variability which are under strong immune
  selection exist within influenza.
  2.
  These epitopes drive the antigenic evolution of influenza.
  3.
  These epitopes cycle between a limited number of different conformations.
  4.
  Epitopes of limited variability would make ideal vaccine targets.
  BWV-101: Universal Influenza Vaccine
  Our approach to developing a novel, universal
  flu vaccine for the prevention and protection against human influenza strains and potential pandemic strains by targeting specific limited
  variability epitopes includes the following steps and processes.
  We are exploring development of an influenza vaccine
  utilizing both the S & P nanoparticles to determine the most effective and efficient presentation of our ELVs and the versatile
  S&P nanoparticle vaccine platform from CHMC with the H1 influenza antigens. Data in preclinical mice (Rotavirus-specific-antibody-free
  BALB/c mice, n=5-7) challenge studies inserted M2e, a spike protein of influenza, into a P-particle loop; showed mice that were vaccinated
  had 100% protection when injected with lethal doses of influenza (Tan et al. JOURNAL OF VIROLOGY, Jan. 2011, p. 753 – 764).
  This dual approach will allow us to gain valuable information as we further the development and manufacturing of the BWV-102 program and
  utilize it for the development of BWV-101. We are currently assessing the ELVs to determine the most effective and efficient route of
  antigen presentation. Additionally, we are currently optimizing antigens for H3 and Flu B to be included with the identified H1 antigens
  to finalize our universal influenza vaccine formulation.
  We are using established manufacturing methods,
  including
  E.coli
  fermentation to produce our chimeric proteins, to reduce the cost and increase the efficiency and scalability
  of our manufacturing process for the vaccine. The antigens will be displayed by a proprietary virus-like particle (VLP) that can be produced
  in
  E. coli
  (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472). Our research and discovery model uses bioinformatics
  and phylogenetic analysis to identify possible sites of epitopes of limited variability before confirming their existence experimentally.
  To date, we have identified naturally immunogenic
  epitopes for H1, H3 and influenza B. Bioinformatics studies and wet lab studies suggest that these epitopes, especially H1N1, and
  the chimeric scaffold configuration of our vaccine induce immunity due to induction of broad cross-reactive antibodies in other strains
  such as H10N3 (bird flu), and pandemic strains including H5NX, H7NX, and H9NX. H9NX (Thompson et al. Nature Communications. 2018.
  9:385). Therefore, we foresee the development of H1N1 vaccine as a priority due to its high cross-reactive priorities.
  BWV-102 Stand-Alone H1 Vaccine
  We are developing our H1 stand-alone influenza
  prophylactic product, BWV-102, to address potential pandemic zoonotic H1 strains, specifically the G4 EA H1N1 identified by scientists
  and reported in June 2020, as a potential next pandemic strain. BWV-102 is being developed using the H1 ELVs identified by the team
  at the University of Oxford. While the product is designed to protect against infection from any H1 strain, there is potential for cross
  protection from H5 and H10 strain infections as well. Preclinical studies were conducted in Balb C mice (n=6) using a prime-boost-boost
  protocol (Thompson et al. Nature Communications. 2018. 9:385). The proposed Phase I clinical study will employ this prime — boost
  protocol; however, it is possible that a single dose of the vaccine candidate will confer protection against current and historical H1
  strains with a prime-boost dose or a single dose.
  As reported in 2020, the G4 EA H1N1 strain is
  the most prevalent influenza strain circulating among swine populations in China. The strain was first identified in 2016 and has been
  monitored by scientists in China through their swine surveillance program. The strain has genes from a mix of pig, avian and human viruses,
  including genes from the 2009 H1N1 flu pandemic virus. Currently, the G4 EA H1N1 strain is not transmissible human to human, however,
  scientists hypothesize that there is a high likelihood of strain reassortment occurring that could make human to human transmissibility
  possible. The current H1N1 influenza strain circulating may provide some protection against disease induced by G4 EA H1N1 infection.
  23
  The ability of the BWV-102 ELVs to induce an immune
  response and protection against heterologous challenge with historical strains was assessed in Balb-C mice (n=6) (
  Thompson et al. Nature
  Communications. 2018. 9:385
  ). We are currently assessing the ELVs in combination with the S
  60
  particle, P
  24
  particle and a proprietary VLP, currently in development, to determine the most effective and efficient route of antigen presentation.
  Manufacturing of the product is expected to occur in
  E. coli (Pharmaceutics 2019, 11, 472; doi:10.3390/pharmaceutics11090472)
  .
  We anticipate results of the VLP presentation assessments in the first half of 2022.
  BWV-201 Streptococcus pneumoniae (S. pneumoniae) Vaccine
  Our BWV-201 vaccine candidate is a live attenuated
  serotype-independent vaccine, for which early data supports further investigation to pursue a long-term preventive intranasal vaccine
  for
  S. pneumoniae
  induced acute otitis media, or AOM. We in-licensed the novel live attenuated
  S. pneumoniae
  strain
  from St. Jude Children's Research Hospital, or St. Jude, as a potential serotype independent vaccine.
  The potential of this vaccine to provide a long-term,
  leading alternative treatment for AOM and subsequent introduction of a novel preventative standard of care. The development of a novel
  vaccine could eradicate potential short-term pain and/or long-term harmful side effects from contracting the virus. Complications from
  AOM include sensorineural hearing loss, or SNHL, in adults but are more relevant for the endangerment of children.
  Researchers from St. Jude developed a strain of
  S. pneumoniae
  that contains greatly reduced virulence yet can transiently colonize the nasopharyngeal cavity, inducing immune responses
  to significantly decrease the incidence of AOM and sinusitis as demonstrated in animal models. Our vaccine production is a straightforward
  process, utilizing the entire novel attenuated bacterium with purification and concentration steps only in the downstream process, thereby
  reducing the time and cost of production significantly compared to commonly used polysaccharide or conjugate vaccines.
  Based on information from the American Academy
  of Pediatrics, over 5 million cases of AOM are reported annually in the U.S., resulting in approximately 30 million medical
  care visits and over 10 million antibiotic prescriptions. AOM is the most common condition treated with antibiotics in the United States
  and increasing antibiotic resistance among the organisms responsible for AOM is of concern to researchers.
  Additional statistics supporting the need for
  a novel preventive vaccine:
  ●
  The global AOM rate is 10.85%, or 709 million cases
  per year, with 51% occurring in children under 5 years old (Tong et al. BMC Health Serv Res. 2018; 18: 318).
  ●
  By 3 years of age, 80% of children globally are expected to have at least one episode of AOM. (Vergison A, Lancet Infect Dis. 2010 Mar;10(3):195-203. Doi: 10.1016/S1473-3099(10)70012-8. PMID: 20185098.).
  ●
  Current treatment for AOM is by antibiotic prescription, with more than 80% of all consultations resulting in a prescription. (Haggard, M. Eur J Pediatr 170, 323 – 332 (2011).
  https://doi.org/10.1007/s00431-010-1286-4
  ).
  ●
  Even with the introduction of the pneumococcal conjugate vaccine (PCV13) in 2010, 26-36% of cases of AOM in U.S. were caused by
  S. pneumoniae.
  (Casey JR, Kaur R, Friedel VC, Pichichero ME. Acute otitis media otopathogens during 2008 to 2010 in Rochester, New York.
  Pediatr Infect Dis J
  . 2013;32(8):805-809. Doi:10.1097/INF.0b013e31828d9acc).
  ●
  Worldwide cases of AOM due to
  S. pneumoniae
  is estimated to be 30-50%. (Bergenfelz C, Hakansson AP. Curr Otorhinolaryngol Rep. 2017;5(2):115-124. Doi: 10.1007/s40136-017-0152-6. Epub 2017 May 20. PMID: 28616365; PMCID: PMC5446555.).
  ●
  An estimated $4.3 billion USD is spent on AOM treatment each year in the U.S. alone. (Tong S, BMC Health Serv Res. 2018 May 2;18(1):318. Doi: 10.1186/s12913-018-3139-1. PMID: 29720156; PMCID: PMC5932897.).
  24
  The current standard of care treatment for AOM
  in children is reliant on antibiotics. The resolution rate of AOM in children is 81% without antibiotic treatment vs. 93% with antibiotic
  treatment. Antibiotic treatment of AOM in children has limitations, including recurrence within 30 days.
  The CDC recommends broad pneumococcal vaccines
  for children younger than 2 and for adults over 65 years of age (CDC). The CDC also recommends vaccinations for children and adults
  age 2 through 64 either previously unvaccinated or partially vaccinated. Two vaccines are currently approved in the U.S. and other
  countries: Prevnar13 or PCV13 (Pfizer) (ii) Pneumovax or PPSV23 (Merck). An additional vaccine, Synflorix, is for approved use outside
  of the U.S. for the prevention of pneumococcal disease and
  S. pneumoniae
  induced AOM for the 10 serotypes included in the
  vaccine.
  Therefore, an effective serotype independent
  S.
  pneumoniae
  AOM vaccine could significantly impact pediatric healthcare demand. As a preventative treatment, the vaccine's advantages
  include: reduction of near-term pain; reduction of recurrent AOM that may result in the need for tympanostomy tube placement; lessening
  of antibiotic usage, which would decrease the number of antibiotic resistant organisms in the environment; and avoiding potential long-term
  hearing loss.
  Previous live, attenuated strains of S. pneumoniae
  were generated by deleting several highly immunogenic virulent genes and therefore may not be optimal vaccine candidates. Some of these
  deletions include antigens that induce antibody responses following pneumococcal carriage and otitis media in young children and therefore
  may not be optimal vaccine candidates.
  Our technology in-licensed from St. Jude focuses
  on candidate genes essential for microbial adaptation to the host environment while maintaining virulence determinants. The St. Jude researchers
  developed a
  S. pneumoniae strain
  with a deletion in
  ftsY
  , a central component of the signal recognition pathway (SRP). SRP
  mutants have greatly reduced virulence, although virulence factors are still produced. The
  S. pneumoniae ftsY
  deletion strain may
  potentially make an ideal live attenuated vaccine, as it can transiently colonize the nasopharyngeal cavity without inducing immune responses
  to virulence protein antigens but does not cause invasive disease.
  Our candidate vaccine is a live attenuated serotype-independent
  vaccine, that early data supports further development to pursue a potential long-term preventive intranasal treatment. BWV-201 will likely
  require two doses to provide life-long protection. BWV-201's has the ability to transiently colonize the nasopharyngeal cavity and
  significantly decrease the incidence of AOM and sinusitis in animal models. The vaccine candidate is derived from the noninvasive serotype
  19F strain BHN97, which normally causes sinusitis/purulent rhinitis and AOM. As previously noted, the
  ftsY
  gene was deleted
  by St. Jude researchers, and is designated BHN97
  ⊗
  ftsY (Rosch, Jason W et al. EMBO molecular
  medicine vol. 6,1 (2014): 141-54. Doi:10.1002/emmm.201202150).
  Our vaccine production is a straightforward approach,
  utilizing the entire bacterium with purification and concentration steps only in the downstream process thereby significantly reducing
  the time and cost of production compared to polysaccharide or conjugate vaccines.
  Preclinical data colonization and invasiveness and Otitis Media/Sinusitis
  Efficacy
  Our pre-clinical data has shown encouraging results
  from the research and development of BWV-201 as a potential intranasal delivered vaccine candidate. Multiple animal models have demonstrated
  protection from AOM.
  To demonstrate vaccine efficacy against AOM and
  sinusitis, mice were immunized (prime and two boosts) with Prevnar 7 (PCV7), Prevnar 13 (PCV13), Pneumovax (PCV23), D39x and BHN197 caxP
  and ftsY deletion mutants. Deletion of ftsY, a central component of the signal recognition particle (SRP) pathway show heightened sensitivity
  to environmental stress and have greatly diminished virulence. Deletion of caxP, a calcium/magnesium transporter, renders host physiological
  conditions in blood and mucosa toxic to the bacterium. BHN97ftsY serotype 19F is also characterized in PCV7, PCV13, and PCV23 (Rosch,
  Jason W et al. EMBO molecular medicine vol. 6,1 (2014): 141-54. Doi:10.1002/emmm.201202150).
  25
  This head-to-head preclinical study mice (n=25-31)
  that were either vaccinated by mock or live attenuated with deletions of either type 2 or 19F backgrounds. This was challenged by bioluminescent
  BMH97X twice daily for AOM and sinusitis. Histopathology was also used to analyze the ears of mice. Xenogen imaging PPV23 was used as
  a negative control.
  Two weeks following the second boost, the
  bioluminescent strain BNH97x (type 19F), a serotype included in Prevnar 7, Pneumovax and BHN97ftsY (referred to as homologous challenge)
  were introduced to the mice. Only BHN97∆ftsY (BWV-201), and to a lesser extent Prevnar 7, showed significant reduction in AOM and
  only BHN97∆ftsY demonstrated significantly reduced sinusitis compared to mock infected animals. The incidence of AOM was significantly
  (
  p
  <0.05 compared to mock) lower in BHN97∆ftsY — vaccinated mice (Figure A-below). Only BHN97∆ftsY
  vaccine significantly decreased the incidence of sinusitis (
  p
  < 0.05). Measurement of luminescence at 24 and 72 h confirmed
  protection engendered by BHN97∆ftsY.
  Figure 7.
  Vaccine protection against otitis
  media and sinusitis. Mice (n=25 – 31 per group, performed at least twice for each group) were mock-vaccinated with PBS
  (Mock) or vaccinated with live attenuated vaccines deleted for caxP or ftsY on either a type2 (D39∆caxP, D39
  ⊗
  ftsY)
  or type19F (BNH97∆caxP, BNH97∆ftsY) background. Mice were challenged with a bioluminescent
  S. pneumoniae
  strain BNH97X
  (type19F) and imaged twice daily for development of AOM or sinusitis. A. The proportion of mice developing an infection of the ear
  or sinus by Xenogen imaging. * =p<0.05 by Chi-squared test compared to the mock vaccinated group. PPV23 was used as a negative control
  (60% otitis and 80% sinusitis). Errors bars represent standard error of the mean. PCV7 is Prevnar 7, PPV23 is Pneumovax and BHN97∆ftsY
  is BWV-201.
  To determine if BHN97∆ftsY, or BWV-201,
  (serotype 19F) can induce heterotypic AOM protection (AOM caused by a
  S. pneumoniae
  serotype not contained in the vaccine), mice
  (n=20) were immunized as detailed above and challenged with BHN54 (serotype 7), which causes otitis media in about 50% of challenged animals.
  The control vaccine Prevnar 13 contains serotype 7; therefore, this study compares heterotypic (BHN97∆ftsY) versus homotypic (Prevnar
  13) vaccine protection. BHN97∆ftsY had a 10-fold lower incidence of AOM, (*p < 0.05) when compared to mock immunized animals,
  demonstrating that the attenuated vaccine does induce heterotypic protection. Bioluminescent signaling as well as, reduction in weight
  loss also demonstrated secondary analysis supporting vaccine protection.
  BHN97∆ftsY induced protection from AOM was
  additionally confirmed in a chinchilla (n=20) animal model. The animals were immunized (prime and two boosts) and then challenged with
  BHN97 two weeks after the final boost. Vaccinated animals had a decreased incidence of culture-positive ears and had a significantly
  decreased number of recoverable bacteria from the middle ear (A). Following vaccination, a reduction in the number of culture positive
  ears in vaccinated group compared to the mock animals was observed (B) as well as significant reduction in recoverable CFUs from
  middle ear 7 days post challenge (C) * = p < 0.05 by Mann — Whitney.
  26
  Figure 8.
  Vaccine protection in a chinchilla
  model of otitis media. The BHN97strain is capable of causing otitis media in chinchillas via intranasal administration as observed by
  recoverable bacterial colony forming units (CFUs) from the middle ear (A) following challenge. B, C Following vaccination with BHN97
  ∆ftsY (BWV-201), a reduction in the number of culture positive ears in the vaccinated group compared to the mock animals was observed
  (B) as well as a significant reduction in recoverable CFUs from the middle ear at 7days post challenge (C). * =p<0.05by Mann — Whitney.
  Vaccine is BHN97 ∆ftsY (BWV-201).
  27
  A potential advantage of an attenuated
  S. pneumoniae
  vaccine such as BHN97∆ftsY is that immune responses are directed to bacterial proteins rather than just polysaccharides and
  should not be limited to serotype specific protection. Purified polysaccharide (PPV) vaccines such as Pneumovax (produced by Merck &Co.)
  and pneumococcal conjugate vaccines such as Prevnar 7/13/20 (produced by Wyeth/Pfizer) or Synflorix (produced by GlaxoSmithKline plc)
  are generally considered serotype specific, inducing protection to disease caused only by pneumococcal strains contained in the vaccines.
  BWV-301 Norovirus-Rotavirus Vaccine Program
  We are developing BWV-201 to prevent acute gastroenteritis,
  or AGE, caused by norovirus and rotavirus, utilizing the P
  24
  nanoparticle of our vaccine platform. The vaccine is based on
  one or two doses of the norovirus P
  24
  nanoparticle presenting 24 rotavirus VP8* antigens. Most cases of gastroenteritis are
  caused by viruses. The CDC reports that viral gastroenteritis infections cause 200,000 deaths in children worldwide each year. Common
  symptoms of viral gastroenteritis causes nausea, vomiting, diarrhea, anorexia, weight loss, and dehydration.
  Gastroenteritis
  Gastroenteritis, often called stomach flu, is
  inflammation of the gastrointestinal tract — the stomach and intestine. Symptoms may include diarrhea, vomiting and abdominal
  pain. Fever, lack of energy and dehydration may also occur. While gastroenteritis is usually caused by viruses, bacteria, parasites, and
  fungus can also cause gastroenteritis. Eating improperly prepared food, drinking contaminated water or close contact with a person who
  is infected can spread the disease. Norovirus and rotavirus are two viruses that cause gastroenteritis in adults and children.
  In 2015, there were two billion cases of gastroenteritis,
  resulting in 1.3 million deaths globally. Children and those in the developing world are affected the most. In 2011, there were about
  1.7 billion cases, resulting in about 700,000 deaths of children under the age of five. In the developing world, children less than
  two years of age frequently get six or more infections a year. It is less common in adults, partly due to the development of immunity.
  In adults, norovirus is the most common cause of severe disease. Rotavirus, however, is the common cause of AGE in children.
  Norovirus
  Norovirus causes significant debilitating AGE,
  with a reported 700 million infections and 20% of all diarrheal cases reported annually worldwide, according to the CDC. About
  200 million cases are seen among children under 5 years old, leading to an estimated 50,000 child deaths every year. Norovirus
  is the cause of approximately 20% of all AGE cases worldwide each year. It is estimated that 68.9 cases of norovirus infection occur in
  every 1000 people. In North America, norovirus induced AGE tends to be seasonal, occurring in cooler, rainy months and particularly
  impacts groups in close proximity, such as in schools, dormitories, medical facilities, and cruise ships.
  Norovirus costs $60.3 billion worldwide each
  year (CDC). Globally, norovirus resulted in a total of approximately $4.2 billion in direct health system costs and approximately
  $60.3 billion in societal costs per year. Disease among children younger than 5 years cost society $39.8 billion, compared
  to $20.4 billion for all other age groups combined. Costs per norovirus illness varied by both region and age and was highest among
  adults ages 55 years and older. Productivity losses represented 84-99% of total costs varying by region. While low and middle
  income countries and high income countries had similar disease incidence (10,148 vs. 9,935 illness per 100,000 persons), high income countries
  generated 62% of global health system costs (Bartsch et al. PloS One 2016; 11:e0151219).
  In North America, the median yearly cost of outbreaks
  was $7.6 million in direct medical costs, and $165.3 million in productivity losses. An average of approximately 113,000 hospitalizations,
  8.2-122.9 million missed school/work days, $0.2-$2.3 billion in direct medical costs, and $1.4-$20.7 billion in productivity
  losses was due to sporadic illness. The total economic impact of norovirus infection was $10.6 billion based on the current incidence
  estimate 68.9 cases per 1000 population, or approximately $0.15 million per person infected.
  28
  The total economic burden is greatest in young
  children but the highest cost per illness is among older age groups in some regions. These large costs overwhelmingly are from productivity
  losses resulting from acute illness. Low, middle, and high income countries all have a considerable economic burden, suggesting that norovirus
  gastroenteritis is a truly global economic problem.
  There is not a norovirus vaccine on the market
  presently. There are, however, a number of rotavirus vaccines currently marketed around the world. RotaTeq, owned by Merck, a live, oral
  pentavalent vaccine and Rotarix, owned by GSK, a monovalent, human, live attenuated vaccine are recommended by the World Health Organization
  (WHO) for global use in children and approved for use in the U.S., Canada and Europe. Other monovalent vaccines are available but only
  approved for use in one country, either China, Vietnam or India.
  Development
  P
  24
  VLPs produced in
  E. coli
  and norovirus VP1 VLPs produced in a baculovirus expression system were both demonstrated to elicit innate, humoral and cellular immunity
  in a mouse model, indicating that both constructs have potential as norovirus virus candidates. In addition, when delivered intranasally
  both constructs were able to induce partial cross-variant protection against diarrhea in a gnotobiotic pig model. Ramesh et al.
  Vaccines
  2019, 7, 777.
  Rotavirus
  Rotavirus is the most common cause of diarrheal
  disease among infants and young children, causing an estimated 111 million episodes of diarrhea annually, 2 million hospitalizations
  and 352,000-592,000 deaths annually, according to the CDC. After the introduction of live attenuated oral vaccines the incidence
  of rotaviral hospitalizations and deaths have significantly declined. However, there is still a need for efficacious, cost-effective rotavirus
  vaccines.
  The rotavirus vaccine is recommended by the CDC
  and ACIP as a prevention for children. However, managing the symptoms is the only way to help adults and children infected with either
  of the viruses. Due to the potential of death, most treatments are focused on dehydration prevention and management. Treatment involves
  getting enough fluids. For mild or moderate cases, this can typically be achieved by drinking oral rehydration solution (a combination
  of water, salts and sugar). In those who are breastfed, continued breastfeeding is recommended. For more severe cases, intravenous fluids
  may be needed and care provided in the hospital. Fluids may also be given by a nasogastric tube. Zinc supplementation is recommended in
  children. Antibiotics are generally not needed. However, antibiotics are recommended for young children with a fever and bloody diarrhea.
  To determine the potential of the P
  24
  VLP to serve as a rotavirus vaccine candidate, the 159 amino acid VP8* protein was inserted into a P
  24
  domain surface
  loop. The fusion proteins self-assembled into P
  24
  VLPs, and the 24 rotavirus VP8* antigens were demonstrated by cryo-EM to
  be displayed on the outermost surface of the chimeric P
  24
  VLP. Mice (n-5-7) immunized intranasally with the P
  24
  -VP8*
  or intramuscularly with Freund's adjuvant elicited significantly higher rotavirus neutralizing antibodies than the free VP8* immunized
  under the same conditions (IN or IM). (P >0.05), (Tan et al. J. Virol. 85(2):753-764. 2011.
  P
  24
  -VP8* VLPs were further characterized
  as a potential rotavirus vaccine in mouse and gnotobiotic pig challenge studies. A construct consisting of P
  24
  and the VP8*
  antigen from the murine rotavirus EDIM strain was constructed and tested using a murine rotavirus challenge model. Mice (n=5-7) were immunized
  with P
  24
  -mouseVP8*, mouseVP8* alone or P
  24
  -human VP8* 3 times intranasally without adjuvant. Rotavirus shedding
  was significantly lower in animals immunized with P
  24
  -mouseVP8* than mock vaccinated or animals that received mouseVP8* only
  or P
  24
  -humanVP8* * (P >0.05) (Tan et al. J. Virol. 85(2):753-764. 2011).
  29
  Additionally, an immunogenicity study was conducted
  in gnotobiotic pigs (n=25). A construct of P
  24
  and the VP8* antigen corresponding to human rotavirus Wa strain was tested in
  a gnotobiotic pig challenge model. Animals were immunized intramuscularly (IM) three times with either P
  24
  -WuVP8* with luminium
  hydroxide adjuvant or luminium hydroxide alone and were challenged with human Wa rotavirus 7 days post dose three. Animals immunized
  with P
  24
  -WuVP8* showed a significant reduction in the mean duration of diarrhea, virus shedding and significantly lower fecal
  cumulative consistency scores compared to adjuvant only control group (*, p < 0.05; **, p < 0.01). (Ramesh et al. Vaccines 7: 177
  2019; doi:10.3390/vaccines7040177).
  Figure 9.
  .P24-VP8* vaccine protected against
  VirHRV diarrhea and reduced overall virus shed among vaccinated pigs. Fecal consistency (A) and virus shedding (B) were monitored
  daily from post challenge day (PCD) 1 to PCD 7 after the challenge with VirHRV. Fecal consistency scores≥2 were considered
  to be diarrheic (dashed line indicates the threshold of diarrhea). Statistical significance between vaccinated and control groups, determined
  by multiple t tests, are indicated by asterisks (*,p<0.05; **,p<0.01).
  Additionally, serum samples were collected from
  the pigs at the times of P
  24
  -VP8* vaccine administration (PID 0, PID 10, PID21 and PID 21) and VirHRV challenge
  (PID 27) and upon euthanasia (PCD 7). The P
  24
  -VP8* vaccine was highly immunogenic in Gn pigs. It induced strong VP8*-specific
  serum IgG and Wa-specific virus-neutralizing antibody responses from post-inoculation day 21 to PCD 7. Comparisons between groups
  at the same time points were carried out using Student's t-test and significant differences are identified by *** (n = 10 – 15;
  p < 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group, where different capital letters
  (A, B, C,D) indicate a significant difference, p < 0.01, and shared letters indicate no significant difference. These findings support
  further investigation of the noro-rotavirus dual nanoparticle vaccine. (Ramesh et al. Vaccines 7: 177 2019; doi:10.3390/vaccines7040177)
  30
  Figure 10.
  Geometric mean VP8*-specific
  IgG (A) and IgA (B) and Wa-HRV neutralizing (C) antibody titers in serum collected from Gn pigs at PID 0, 10, 21,
  28, and PCD 7. Pigs were vaccinated with P24-VP8* vaccine or Al(OH)3 adjuvant only. Each serum specimen was tested at an initial dilution
  of 1:4. Negative samples were assigned an arbitrary value of 2 for calculation and graphical illustration purposes. Comparisons between
  groups at the same time points were carried out using Student's t-test and significant differences are identified by *** (n
  = 10 – 15; p < 0.001). Tukey-Kramer HSD was used for the comparison of different time points within the same group,
  where different capital letters (A, B, C, D) indicate a significant difference, p < 0.01, and shared letters indicate no significant
  difference.
  31
  An effective norovirus culture-based neutralization
  assay is not available, due to the lack of an efficient cell culture system to produce human norovirus. Therefore, a surrogate neutralization
  assay has been developed in the field, measuring the ability of antisera to block norovirus VLP binding to host receptors. In addition
  to generating rotavirus neutralizing antibody, Tan et al (J. Virol. 86:753-764. 2011) demonstrated that anti- P
  24
  -VP8*
  mouse sera blocked norovirus VLP binding, indicating that the insertion of the VP8* fragment did not inhibit induction of norovirus VLP
  binding antibodies and suggesting the P
  24
  -VP8 construct could potentially serve as a single vaccine against both rotavirus
  and norovirus disease (P >0.05).
  Our Vaccine
  We hold the exclusive global license for the novel
  norovirus-rotavirus combination vaccine (except in China and Hong Kong) from Cincinnati Children's Hospital Medical Center,
  or CHMC, CHMC researchers engineered the norovirus major structural protein VP1 such that the N-terminal shell (S) and C-terminal
  protruding (P) domains of VPI could be expressed as separate S
  60
  and P
  24
  virus-like particles (VLPs). Unlike
  norovirus VLPs composed of the intact VP1 protein or the unmodified S
  60
  fragment, our S
  60
  and P
  24
  VLPs
  can be expressed in
  E. coli
  . The researchers demonstrated that S
  60
  VLPs could be used to present foreign antigens on
  the surface of the S
  60
  VLP. Further, it has also demonstrated that foreign antigens could also be expressed on the surface
  of the P
  24
  VLP. The proposed norovirus-rotavirus vaccine is based on the P
  24
  VLP technology. Our vaccine production
  is based on an
  E.coli
  expression platform.
  Development
  Following IND submission, if accepted, we intend
  to initiate our Phase I clinical trial in healthy adults ages 18 to 54. If approved, we believe our vaccine is well positioned
  to receive a recommendation from the CDC, ACIP, and similar international advisory groups for inclusion in vaccine programs.
  BWV-302: Norovirus-malaria vaccine program
  Additionally, we are currently investigating a
  malaria vaccine, BWV-302, utilizing our norovirus platform. The vaccine is designed to offer protection from both norovirus and malaria,
  infectious diseases that occur frequently together in geographic regions. The vaccine utilizes a protein identified on the surface of
  the plasmodium parasite being presented on the surface of the norovirus nanoparticle.
  Malaria
  Malaria can be a deadly disease caused by protozoan
  parasites from the Plasmodium family, primarily spread by mosquitos (CDC,
  https://wwwnc.cdc.gov/travel/diseases/malaria)
  . Malaria
  may also, at times, be transmitted through blood transfusion, organ transplantation and from mother to fetus. (CDC,
  https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/malaria
  ).
  While transmission through blood transfusion is rare in the U.S., there are no approved blood tests currently available to screen blood
  donation for malaria. There were approximately 219 million cases of malaria reported in 2019 globally, resulting in approximately
  409,000 deaths, of which approximately 67% were children. (WHO,
  https://www.who.int/news-room/fact-sheets/detail/malaria
  ). Symptoms
  of malaria normally manifest themselves within 7 to 10 days of exposure, and can at times, be mistaken for other illnesses, including
  influenza. Severe malaria is life-threatening and can cause multi-organ failure in adults and severe anemia, metabolic acidosis and cerebral
  malaria in children. The World Health Organization estimates that almost half of the global population is at risk of contracting malaria.
  Infants, children under 5 years of age, pregnant women and immune compromised individuals are highest risk of developing the disease.
  Additionally, non-immune migrants, mobile populations and travelers are at risk of developing severe disease. Neurological issues in children
  may continue to persist after cerebral malaria, including ataxia, palsy, speech impairment, deafness and blindness.
  32
  More than 100 species of Plasmodium have been
  identified. Four of the species have been recognized as naturally infecting humans, while one that infects macaques and has been identified
  as a cause of zoonotic malaria. In rare cases, additional species may infect humans. The primary four parasites that cause human infection
  are
  P. falciparum, P. vivax, P. ovale and
  (
  https://www.cdc.gov/malaria/about/biology/index.html
  ).
  P. knowlesi
  is naturally occurring in macaques in Southeast Asia and has recently been reported as the cause zoonotic malaria, especially in Malaysia.
  P. falciparum
  is found world-wide, can cause severe malaria and is the predominate human malaria causing species around the world.
  There is currently one vaccine for malaria, RTS,S/AS01
  (MVI-GSK) targeting the falciparum CS protein, which received a positive opinion from the European Medicines Agency (EMA) for use outside
  of the European Union in infants 6 weeks of age and older. (
  https://www.ema.europa.eu/en/news/first-malaria-vaccine-receives-positive-scientific-opinion-ema
  )
  According to the EMA, the World Health Organization and the relevant regulatory agencies for countries outside of the European Union can
  authorize its use. The vaccine is currently being administered to infants and children in parts of Africa within high transmission regions.
  The vaccine's efficacy appears to wane after five years (Laurens MB. RTS,S/AS01 vaccine (Mosquirix™): an overview.
  Hum Vaccin Immunother.
  2020;16(3):480-489. Doi:10.1080/21645515.2019.1669415). The recommended course of action for preventing
  malaria is prevention of mosquito bites, and for those most vulnerable, a preventative treatment with sulfadoxine-pyrimethamine, especially
  in high transmission areas (WHO). In certain regions, the WHO has recommended the addition of amodiaquine to children under 5 years
  of age monthly during the high transmission season, along with sulfadoxine-pyrimethamine. Many regions employ mosquito control measures
  to reduce mosquito populations, however, 73 countries have reported mosquito resistance to at least 1 of the 4 most commonly used insecticides,
  while 23 countries have reported mosquito resistance to all of the commonly used insecticides.
  Once malaria is diagnosed, the two most common
  treatments are Chloroquine phosphate and Artemisinin-based combination (ACT) therapies. Chloroquine is the preferred treatment, however,
  some malaria parasites have become resistant to chloroquine and it may not be an effective treatment. ACT is a combination of two or more
  drugs that work against the malaria parasite in different ways. This is usually the preferred treatment for chloroquine-resistant malaria.
  However, as recently reported in Nature Medicine, there is growing concern about Artemisinin — derivative resistant P.falciparum
  in the Greater Mekong subregion (Cambodia, Thailand, Vietnam, Myanmar and Laos) (
  https://www.nature.com/articles/s41591-020-1005-2.pdf
  ).
  Previous occurrences of resistant strains also first appeared in the Greater Mekong subregion and then spread to other parts of the world.
  (
  https://www.nature.com/articles/s41591-020-1005-2.pdf
  ).
  33
  Our Vaccine
  We hold the exclusive global license for the novel
  norovirus-malaria combination vaccine from Cincinnati Children's Hospital Medical Center, or CHMC, CHMC researchers engineered the
  norovirus major structural protein VP1 such that the N-terminal shell (S) and C-terminal protruding (P) domains of VPI could
  be expressed as separate S
  60
  and P
  24
  virus-like particles (VLPs). Unlike norovirus VLPs composed of the intact VP1
  protein or the unmodified S
  60
  fragment, our S
  60
  and P
  24
  VLPs can be expressed in
  E. coli
  . The researchers,
  Xi Jason Jiang, Ph.D., and Ming Tan, Ph.D., demonstrated that S
  60
  VLPs could be used to present foreign antigens on the surface
  of the S
  60
  VLP. Further, it has also demonstrated that foreign antigens could also be expressed on the surface of the
  P
  24
  VLP. (see
  BWV Norovirus (NoV) S&P Nanoparticle Versatile Vaccine Platform
  ). The proposed norovirus-malaria
  vaccine, P-CS)TSR is based on the P
  24
  VLP technology. Our vaccine production is based on an
  E.coli
  expression platform.
  The circumsporozoite (CS) protein is the major
  surface component of
  P. falciparum
  sporozoites and is essential for host cell invasion. Our vaccine, developed by Jiang and Ming
  from CHMC, combines a small domain of the CS protein with the norovirus P
  24
  particle creating a chimeric nanoparticle capable
  of eliciting an immune response. A mouse immunization study was conducted using the P
  24
  particle presenting the small domain
  of the CS protein. Mice (n=16) were immunized three times with the chimeric nanoparticle using aluminum hydroxide as an adjuvant, 3D7-His,
  3D7-GST and PBS. Sera was collected and evaluated.
  High antibody titers, as determined by ELISA,
  were observed after the second immunization and higher titers were observed after the third immunization. The antibodies were also shown
  to recognize the plasmodium falciparum 3D7 strain using immunofluorescence assays. These data demonstrate the potential of our vaccine
  candidate against malaria. We expect to conduct an animal challenge study to further analyze the protective nature of BWV-302 and support
  an IND application.
  Table 3. Mouse malaria antibody titer post-immunization
  Antibody titer after 2
  nd
  immunization
  Antibody titer after 3
  rd
  immunization
  Figure 11. IFA of plasmodium sporozoites (3D7)
  stained with anti-P
  24
  particle presenting the small domain of the CS protein mouse sera
  34
  Development
  We anticipate conducting an animal challenge study
  for BWV-302 in the second half of 2023. Upon completion, the technology will be transferred to a partner CDMO for process optimization,
  GMP production and toxicology studies, as well as other studies required by the FDA for IND submission.Following IND submission immediately
  upon completion of the toxicology study, if successful, we intend to initiate our Phase I clinical trial in healthy adults ages 18
  to 54 upon acceptance by the FDA.
  Government Regulation and Product Approval
  The FDA and other regulatory authorities at federal,
  state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
  manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval,
  advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those we are developing.
  Small molecule drugs are subject to regulation
  under the Food, Drug, and Cosmetic Act, or FDCA, and biological products are additionally subject to regulation under the Public Health
  Service Act, or PHSA, and both are subject to additional federal, state, local and foreign statutes and regulations. We, along with third-party
  contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory
  agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product candidates.
  United States
  U. S. Biopharmaceuticals Regulation
  The process required by the FDA before drug and
  biologic product candidates may be marketed in the United States generally involves the following:
  ●
  completion of extensive preclinical laboratory tests and animal studies performed in accordance with applicable regulations, including the FDA's Good Laboratory Practice, or GLP, regulations;
  ●
  submission to the FDA of an investigational new drug application, IND, which must become effective before clinical trials may begin;
  ●
  approval by an independent institutional review board or ethics committee at each clinical site before the trial is commenced;
  ●
  performance of adequate and well-controlled human clinical trials in accordance with FDA's Good Clinical Practice, or GCP, regulations to establish the safety and efficacy of a drug candidate and safety, purity and potency of a proposed biologic product candidate for its intended purpose;
  ●
  preparation of and submission to the FDA of a new drug application, or NDA, or biologics license application, or BLA, as applicable, after completion of all pivotal clinical trials;
  ●
  satisfactory completion of an FDA Advisory Committee review, if applicable;
  ●
  a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;
  ●
  satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing Practice requirements, or cGMPs, and of selected clinical investigation sites to assess compliance with GCPs; and
  ●
  FDA review and approval of an NDA, or licensure of a BLA, to permit commercial marketing of the product for particular indications for use in the United States.
  35
  Preclinical and Clinical Development
  Prior to beginning the first clinical trial with
  a product candidate, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational
  new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol or protocols
  for preclinical studies and clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics,
  pharmacology and harmacodynamics characteristics of the product, chemistry, manufacturing and controls information, and any available
  human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials
  may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises
  safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor
  and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may
  or may not result in FDA authorization to begin a clinical trial.
  Clinical trials involve the administration of
  the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include
  the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials
  are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety
  and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial
  conducted during product development and for any subsequent protocol amendments. Furthermore, an independent institutional review board
  for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent
  form before the clinical trial begins at that site, and must monitor the study until completed. Regulatory authorities, the institutional
  review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being
  exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight
  by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides
  authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and
  may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration
  of efficacy.
  For purposes of biopharmaceutical development,
  human clinical trials are typically conducted in three sequential phases that may overlap or be combined;
  ●
  Phase 1.
  The investigational product is initially introduced into patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
  ●
  Phase 2.
  The investigational product is administered to a limited patient population to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
  ●
  Phase 3.
  The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
  In some cases, the FDA may require, or companies
  may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called
  Phase 4 studies may be made a condition to approval of the application. Concurrent with clinical trials, companies may complete additional
  animal studies and develop additional information about the characteristics of the product candidate and must finalize a process for manufacturing
  the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing
  quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and
  purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and
  tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over
  its shelf life.
  36
  During all phases of clinical development, regulatory
  agencies require extensive monitoring and auditing of all clinical activities, clinical data, and clinical study investigators. The FDA
  or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that
  the research patients or patients are being exposed to an unacceptable health risk. Similarly, an institutional review board can suspend
  or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the institutional
  review board's requirements or if the biological product candidate has been associated with unexpected serious harm to patients.
  There are also requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries.
  Sponsors of clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information, which
  is publicly available at
  www.clinicaltrials.gov
  .
  NDA/BLA Submission and Review
  Assuming successful completion of all required
  testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical
  trials are submitted to the FDA as part of an NDA or BLA, as applicable, requesting approval to market the product for one or more indications.
  The application must include all relevant data available from pertinent preclinical studies and clinical trials, including negative or
  ambiguous results as well as positive findings, together with detailed information relating to the product's chemistry, manufacturing,
  controls, and proposed labeling, among other things. The submission of an application requires payment of a substantial application user
  fee to the FDA, unless a waiver or exemption applies. The FDA has sixty days from the applicant's submission to either issue
  a refusal to file letter or accept the application for filing, indicating that it is sufficiently complete to permit substantive review.
  Once an NDA or BLA has been accepted for filing,
  the FDA's goal is to review standard applications within 10 months after it accepts the application for filing, or, if the
  application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority
  reviews, the review process is often significantly extended by FDA requests for additional information or clarification. The FDA reviews
  an NDA to determine whether a drug is safe and effective for its intended use and a BLA to determine whether a biologic is safe, pure
  and potent. FDA also reviews whether the facility in which the product is manufactured, processed, packed or held meets standards designed
  to assure and preserve the product's identity, safety, strength, quality, potency and purity. The FDA may convene an advisory committee
  to provide clinical insight on application review questions. Before approving an NDA or BLA, the FDA will typically inspect the facility
  or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes
  and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
  Additionally, before approving an application, the FDA will typically inspect one or more clinical sites to assure compliance with GCPs.
  If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the
  deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested
  additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
  After the FDA evaluates an application and conducts
  inspections of manufacturing facilities where the investigational product and/or its drug substance will be manufactured, the FDA may
  issue an approval letter or a Complete Response letter. An approval letter authorizes commercial marketing of the product with specific
  prescribing information for specific indications. A Complete Response letter will describe all of the deficiencies that the FDA has identified
  in the application, except that where the FDA determines that the data supporting the application are inadequate to support approval,
  the FDA may issue the Complete Response letter without first conducting required inspections, testing submitted product lots and/or reviewing
  proposed labeling. In issuing the Complete Response letter, the FDA may recommend actions that the applicant might take to place the application
  in condition for approval, including requests for additional information or clarification, which may include the potential requirement
  for additional clinical studies. The FDA may delay or refuse approval of an application if applicable regulatory criteria are not satisfied,
  require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.
  If regulatory approval of a product is granted,
  such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be
  marketed. For example, the FDA may approve the application with a risk evaluation and mitigation strategy, or REMS, to ensure the benefits
  of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a product and
  to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician
  communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization
  tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls
  and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is
  not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market
  studies and surveillance to further assess and monitor the product's safety and effectiveness after commercialization, and may limit
  further marketing of the product based on the results of these post-marketing studies.
  37
  Expedited Development and Review Programs
  The FDA offers a number of expedited development
  and review programs for qualifying product candidates. The fast track program is intended to expedite or facilitate the process for reviewing
  new products that meet certain criteria. Specifically, new products are eligible for fast track designation if they are intended to treat
  a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.
  Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor
  of a fast track product has opportunities for frequent interactions with the review team during product development and, once an NDA or
  BLA is submitted, the product may be eligible for priority review. A fast track product may also be eligible for rolling review, where
  the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor
  provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines
  that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.
  A product intended to treat a serious or life-threatening
  disease or condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product can receive
  breakthrough therapy designation if preliminary clinical evidence indicates that the product, alone or in combination with one or more
  other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints,
  such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features,
  as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite
  the development and review of the product, including involvement of senior managers.
  Any marketing application for a drug or biologic
  submitted to the FDA for approval, including a product with a fast track designation and/or breakthrough therapy designation, may be eligible
  for other types of FDA programs intended to expedite the FDA review and approval process, such as priority review and accelerated approval.
  A product is eligible for priority review if it has the potential to provide a significant improvement in the treatment, diagnosis or
  prevention of a serious disease or condition. Priority review designation means the FDA's goal is to take action on the marketing
  application within six months of the 60-day filing date.
  Additionally, products studied for their safety
  and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination
  that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint
  that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible
  morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability
  or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to perform adequate
  and well-controlled post-marketing clinical studies to verify and describe the anticipated effect on irreversible morbidity or mortality
  or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional
  materials, which could adversely impact the timing of the commercial launch of the product.
  Fast track designation, breakthrough therapy designation
  and priority review do not change the standards for approval but may expedite the development or approval process. Even if a product qualifies
  for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide
  that the time period for FDA review or approval will not be shortened.
  Orphan Drug Designation
  Under the Orphan Drug Act, the FDA may grant orphan
  designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than
  200,000 individuals in the United States, or more than 200,000 individuals in the United States for which there is no reasonable
  expectation that the cost of developing and making available in the United States a drug or biologic for this type of disease or
  condition will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested
  before submitting an NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and
  its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or shorten
  the duration of, the regulatory review or approval process.
  38
  If a product that has orphan drug designation
  subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan drug
  exclusive approval (or exclusivity), which means that the FDA may not approve any other applications, including a full NDA or BLA, to
  market the same drug or biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical
  superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown
  that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition
  for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the
  same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug
  designation are tax credits for certain research and a waiver of the NDA or BLA application fee.
  A designated orphan drug may not receive orphan
  drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition,
  exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially
  defective.
  Post-Approval Requirements
  Any products manufactured or distributed by us
  pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating
  to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion
  of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject
  to prior FDA review and approval. There also are continuing user fee requirements, under which the FDA assesses an annual program fee
  for each product identified in an approved NDA or BLA. Biopharmaceutical manufacturers and their subcontractors are required to register
  their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain
  state agencies for compliance with cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.
  Changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require prior FDA approval
  before being implemented. FDA regulations also require investigation and correction of any deviations from cGMPs and impose reporting
  requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time,
  money and effort in the area of production and quality control to maintain compliance with cGMPs and other aspects of regulatory compliance.
  The FDA may withdraw approval if compliance with
  regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of
  previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
  or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
  of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions
  under a REMS program. Other potential consequences include, among other things:
  ●
  restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;
  ●
  fines, warning or untitled letters or holds on post-approval clinical studies;
  ●
  refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;
  ●
  product seizure or detention, or refusal of the FDA to permit the import or export of products;
  ●
  consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;
  ●
  mandated modification of promotional materials and labeling and the issuance of corrective information;
  ●
  the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or
  ●
  injunctions or the imposition of civil or criminal penalties.
  39
  The FDA closely regulates the marketing, labelling,
  advertising and promotion of biopharmaceutical products. A company can make only those claims relating to safety and efficacy, purity
  and potency that are approved by the FDA and in accordance with the provisions of the approved label. However, companies may share truthful
  and not misleading information that is otherwise consistent with a product's FDA approved labelling. The FDA and other agencies
  actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result
  in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians
  may prescribe legally available products for uses that are not described in the product's labelling and that differ from those tested
  by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label
  uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice
  of treatments. The FDA does, however, restrict manufacturer's communications on the subject of off-label use of their products.
  U.S. Market Exclusivity
  A biological product can obtain pediatric market
  exclusivity in the U.S., which, if granted, adds six months to existing exclusivity periods, including some regulatory exclusivity
  periods tied to patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may
  be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued "Written Request" for such
  a study.
  The Biologics Price Competition and Innovation
  Act of 2009, or BPCIA, created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable
  with, an FDA-licensed reference biological product. This amendment to the PHSA attempts to minimize duplicative testing.
  Biosimilarity, which requires that there be no
  clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can
  be shown through analytical studies, animal studies, and a clinical trial or trials. Interchangeability requires that a product is biosimilar
  to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference
  product and, for products administered multiple times, the biologic and the reference biologic may be interchanged after one has been
  previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic.
  However, complexities associated with the larger, and often more complex, structure of biological products, as well as the process by
  which such products are manufactured, pose significant hurdles to implementation that are still being worked out by the FDA.
  The FDA will not accept an application for a biosimilar
  or interchangeable product based on the reference biological product until four years after the date of first licensure of the reference
  product, and the FDA will not approve an application for a biosimilar or interchangeable product based on the reference biological product
  until 12 years after the date of first licensure of the reference product. "First licensure" typically means the initial
  date the particular product at issue was licensed in the U.S. Date of first licensure does not include the date of licensure of (and
  a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product
  or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or
  other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication,
  route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure
  of the biological product that does not result in a change in safety, purity, or potency.
  The BPCIA is complex and continues to be interpreted
  and implemented by the FDA. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period.
  Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation.
  As a result, the ultimate implementation and impact of the BPCIA is subject to significant uncertainty.
  40
  Pediatric Study Plan and Pediatric Exclusivity
  Under the Pediatric Research Equity Act, as amended,
  or the PREA, certain NDAs and certain NDA supplements must contain data that can be used to assess the safety and efficacy of the product
  candidate for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric
  subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial
  waivers. The PREA requires that a sponsor who is planning to submit a marketing application for a product candidate that includes a new
  active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study
  Plan, or the PSP, within 60 days of an end-of-phase 2 meeting or, if there is no such meeting, as early as practicable before the
  initiation of the phase 3 or phase 2/3 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor
  plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for
  not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement
  to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A
  sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on
  data collected from preclinical studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required
  by regulation, the PREA does not apply to a drug for an indication for which orphan designation has been granted, except that the PREA
  will apply to an original NDA for a new active ingredient that is orphan-designated if the drug is a molecularly targeted cancer product
  intended for the treatment of an adult cancer and is directed at a molecular target that the FDA determines to be substantially relevant
  to the growth or progression of a pediatric cancer.
  A drug can also obtain pediatric market exclusivity
  in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This
  six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion
  of a pediatric study in accordance with an FDA-issued "Written Request" for such a study.
  Patent Term Restoration and Extension
  Depending upon the timing, duration and specifics
  of the FDA approval of our product candidates, some of our U.S. patents may be eligible for limited patent term extension. The provisions
  of the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, permit a patent restoration term
  of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. However,
  patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product's approval
  date. The patent term restoration period is generally one-half the time between the effective date of an IND and the submission date of
  a BLA plus the time between the submission date of a BLA and the approval of that application. Only one patent applicable to an approved
  product is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. The
  USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future,
  we may apply for restoration of patent term for one of our currently owned or licensed patents to add patent life beyond its current expiration
  date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant BLA.
  Many other countries also provide for patent term
  extensions or similar extensions of patent protection for biologic products. For example, in Japan, it may be possible to extend the patent
  term for up to five years and in Europe, it may be possible to obtain a supplementary patent certificate that would effectively extend
  patent protection for up to five years.
  41
  Federal and State Fraud and Abuse, Data Privacy and Security, and
  Transparency Laws and Regulations
  In addition to FDA restrictions on marketing of
  pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry.
  These laws may impact, among other things, our current and future business operations, including our clinical research activities, and
  proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare
  providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws
  include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including,
  without limitation, those laws described below.
  The U.S. federal Anti-Kickback Statute prohibits
  any person or entity from, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce
  or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable
  under Medicare, Medicaid or other federal healthcare programs. The term "remuneration" has been broadly interpreted to include
  anything of value. The U.S. federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers
  on the one hand and prescribers, purchasers and formulary managers on the other. Although there are a number of statutory exceptions and
  regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices
  that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny
  if they do not qualify for an exception or safe harbor. Several courts have interpreted the statute's intent requirement to mean
  that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the statute
  has been violated.
  A person or entity does not need to have actual
  knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the government may assert
  that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false
  or fraudulent claim for purposes of the federal civil False Claims Act or the civil monetary penalties laws.
  42
  Federal civil and criminal false claims laws and
  civil monetary penalties laws, including the federal civil False Claims Act, which can be enforced by individuals through civil whistleblower
  and qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false
  claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material
  to a false or fraudulent claim to the federal government. A claim includes "any request or demand" for money or property presented
  to the U.S. government. Several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly
  providing free product to customers with the expectation that the customers would bill federal programs for the product. Other companies
  have been prosecuted for causing false claims to be submitted because of the companies' marketing of products for unapproved, and
  thus non-reimbursable, uses.
  The federal Health Insurance Portability and Accountability
  Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully
  executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying,
  concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery
  of or payment for healthcare benefits, items or services. Also, many states have similar fraud and abuse statutes or regulations that
  apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
  In addition, we may be subject to data privacy
  and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health
  Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose specified
  requirements on certain types of individuals and entities relating to the privacy, security and transmission of individually identifiable
  health information. Among other things, HITECH makes HIPAA's security standards directly applicable to "business associates,"
  defined as independent contractors or agents of covered entities, which include certain healthcare providers, healthcare clearinghouses
  and health plans, that create, receive, maintain or transmit individually identifiable health information in connection with providing
  a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered
  entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages
  or injunctions in federal courts to enforce HIPAA and seek attorney's fees and costs associated with pursuing federal civil actions.
  In addition, state laws govern the privacy and security of health information in certain circumstances, many of which are not pre-empted
  by HIPAA, differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
  The federal Physician Payments Sunshine Act requires
  certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the
  Children's Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid
  Services, or CMS, information related to payments or other transfers of value made to physicians and teaching hospitals, and applicable
  manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians
  and their immediate family members.
  We may also be subject to state laws that require
  pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance
  guidance promulgated by the federal government, state laws that require drug manufacturers to report information related to payments and
  other transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing, and state and local laws
  that require the registration of pharmaceutical sales representatives.
  Because of the breadth of these laws and the narrowness
  of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities could be subject to
  challenge under one or more of such laws. If our operations are found to be in violation of any of the federal and state laws described
  above or any other governmental regulations that apply to us, we may be subject to significant criminal, civil and administrative penalties
  including damages, fines, imprisonment, disgorgement, additional reporting requirements and oversight if we become subject to a corporate
  integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm,
  diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs and the curtailment
  or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.
  To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which
  may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws, implementation
  of corporate compliance programs, reporting of payments or transfers of value to healthcare professionals, and additional data privacy
  and security requirements.
  43
  Healthcare Reform
  Coverage and Reimbursement
  The future commercial success of our product candidates,
  if approved, will depend in part on the extent to which third-party payors, such as governmental payor programs at the federal and state
  levels, including Medicare and Medicaid, private health insurers and other third-party payors, provide coverage of and establish adequate
  reimbursement levels for our product candidates. Third-party payors generally decide which products they will pay for and establish reimbursement
  levels for those products. In particular, in the United States, no uniform policy for coverage and reimbursement exists. Private
  health insurers and other third-party payors often provide coverage and reimbursement for products based on the level at which the government,
  through the Medicare program, provides coverage and reimbursement for such products, but also on their own methods and approval process
  apart from Medicare determinations. Therefore, coverage and reimbursement can differ significantly from payor to payor.
  In the United States, the European Union,
  or EU, and other potentially significant markets for our product candidates, government authorities and third-party payors are increasingly
  attempting to limit or regulate the price of products, particularly for new and innovative products, which often has resulted in average
  selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United States and
  on country and regional pricing and reimbursement controls in the EU will put additional pressure on product pricing, reimbursement and
  usage. These pressures can arise from rules and practices of managed care groups, judicial decisions and laws and regulations related
  to Medicare, Medicaid and healthcare reform, pharmaceutical coverage and reimbursement policies and pricing in general.
  Third-party payors are increasingly imposing additional
  requirements and restrictions on coverage and limiting reimbursement levels for products. For example, federal and state governments reimburse
  products at varying rates generally below average wholesale price. These restrictions and limitations influence the purchase of products.
  Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved
  products for a particular indication. Similarly, because certain of our product candidates are physician-administered, separate reimbursement
  for the product itself may or may not be available. Instead, the administering physician may only be reimbursed for providing the treatment
  or procedure in which our product is used. Third-party payors are increasingly challenging the price and examining the medical necessity
  and cost-effectiveness of products, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies
  in order to demonstrate the medical necessity and cost-effectiveness of our product candidates, in addition to the costs required to obtain
  the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A payor's decision to provide
  coverage for a product does not imply that an adequate reimbursement rate will be approved. Adequate third-party payor reimbursement may
  not be available to enable us to realize an appropriate return on our investment in product development. Legislative proposals to reform
  healthcare or reduce costs under government insurance programs may result in lower reimbursement for our product candidates, if approved,
  or exclusion of our product candidates from coverage and reimbursement. The cost containment measures that third-party payors and providers
  are instituting and any healthcare reform could significantly reduce our revenue from the sale of any approved product candidates.
  The United States and some foreign jurisdictions
  are considering enacting or have enacted a number of additional legislative and regulatory proposals to change the healthcare system in
  ways that could affect our ability to sell our product candidates profitably, if approved. Among policy makers and payors in the United States
  and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare
  costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these
  efforts, which include major legislative initiatives to reduce the cost of care through changes in the healthcare system, including limits
  on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded healthcare
  programs, and increased governmental control of drug pricing.
  44
  There have been several U.S. government initiatives
  over the past few years to fund and incentivize certain comparative effectiveness research, including creation of the Patient-Centered
  Outcomes Research Institute under the ACA. It is also possible that comparative effectiveness research demonstrating benefits in
  a competitor's product could adversely affect the sales of our product candidates.
  The ACA became law in March 2010 and substantially
  changed the way healthcare is financed by third-party payors, and significantly impacts the U.S. pharmaceutical industry. Among other
  measures that may have an impact on our business, the ACA established an annual, nondeductible fee on any entity that manufactures or
  imports specified branded prescription drugs and biologic agents; a new Medicare Part D coverage gap discount program; and a new
  formula that increased the rebates a manufacturer must pay under the Medicaid Drug Rebate Program. Additionally, the ACA extended manufacturers'
  Medicaid rebate liability, expands eligibility criteria for Medicaid programs, and expanded entities eligible for discounts under the
  Public Health Service Act. At this time, we are unsure of the full impact that the ACA will have on our business.
  Since its enactment, there have been judicial
  and Congressional challenges to certain aspects of the ACA, as well as recent efforts by the Trump administration to repeal or replace
  certain aspects of the ACA, and we expect such challenges and amendments to continue. Since January 2017, President Trump has signed
  two Executive Orders and other directives designed to delay the implementation of certain ACA provisions or otherwise circumvent requirements
  for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace
  all or part of the ACA. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of
  certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017, or Tax Act, includes a provision that
  repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail
  to maintain qualifying health coverage for all or part of a year that is commonly referred to as the "individual mandate."
  On January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation
  of certain ACA-mandated fees, including the so-called "Cadillac" tax on certain high cost employer-sponsored insurance plans,
  the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on nonexempt medical
  devices. The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the ACA, effective January 1, 2019,
  to increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D
  and to close the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole." In July 2018, CMS
  published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance
  issuers under the ACA adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses
  to determine this risk adjustment. In December 2018, a U.S. District Court Judge in the Northern District of Texas, or Texas
  District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was
  repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well. While the Texas District Court Judge, as well
  as the Trump administration and CMS, have stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent
  appeals, and other efforts to repeal and replace the ACA will impact the ACA.
  In addition, other legislative changes have been
  proposed and adopted since the ACA was enacted. In August 2011, the President signed into law the Budget Control Act of 2011,
  as amended, which, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began
  in 2013 and, following passage of subsequent legislation, including the BBA, will continue through 2027 unless additional Congressional
  action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was enacted which, among other things, reduced
  Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments
  to providers from three to five years.
  45
  Further, there has been increasing legislative
  and enforcement interest in the United States with respect to drug pricing practices. Specifically, there have been several recent
  U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency
  to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement
  methodologies for drugs. At the federal level, the Trump administration's budget proposal for fiscal year 2019 contains further
  drug price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example,
  measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states
  to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. Additionally, the Trump
  administration released a "Blueprint" to lower drug prices and reduce out of pocket costs of drugs that contains additional
  proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers
  to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. The U.S. Department
  of Health and Human Services, or HHS, has already started the process of soliciting feedback on some of these measures and is implementing
  others under its existing authority. For example, in September 2018, CMS announced that it will allow Medicare Advantage plans the
  option to use step therapy for Part B drugs beginning January 1, 2019. On January 31, 2019, the HHS Office of Inspector
  General proposed modifications to U.S. federal Anti-Kickback Statute safe harbors which, among other things, may affect rebates paid
  by manufacturers to Medicare Part D plans, the purpose of which is to further reduce the cost of drug products to consumers. In addition,
  CMS issued a final rule, effective on July 9, 2019, that requires direct-to-consumer television advertisements of prescription drugs
  and biological products, for which payment is available through or under Medicare or Medicaid, to include in the advertisement the Wholesale
  Acquisition Cost, or list price, of that drug or biological product if it is equal to or greater than $35 for a monthly supply or usual
  course of treatment. Prescription drugs and biological products that are in violation of these requirements will be included on a public
  list. Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures
  to control drug costs. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control
  pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain
  product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other
  countries and bulk purchasing. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures
  to determine which drugs and suppliers will be included in their healthcare programs. Furthermore, there has been increased interest by
  third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices. These measures
  could reduce future demand for our products or put pressure on our pricing.
  Additionally, in May 2018, the Trickett Wendler,
  Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, or the Right to Try Act, was signed into law.
  The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that
  have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible
  patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program.
  There is no obligation for a drug manufacturer to make its drug products available to eligible patients as a result of the Right to Try
  Act.
  Foreign Regulation
  In order to market any product outside of the
  United States, we would need to comply with numerous and varying regulatory requirements of other countries regarding safety and
  efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution of our product
  candidates. For example, in the EU, we must obtain authorization of a clinical trial application, or CTA, in each member state in which
  we intend to conduct a clinical trial. Whether or not we obtain FDA approval for a drug, we would need to obtain the necessary approvals
  by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those
  countries. The approval process varies from country to country and can involve additional product testing and additional administrative
  review periods. The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA
  approval. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory
  approval in one country may negatively impact the regulatory process in others.
  46
  Further, some countries outside of the United States,
  including the EU member states, Switzerland and the United Kingdom, have also adopted data protection laws and regulations, which impose
  significant compliance obligations. In the EU, the collection and use of personal health data is governed by the provisions of the General
  Data Protection Regulation, or GDPR. The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing
  responsibility and liability of pharmaceutical companies in relation to the processing of personal data of EU subjects. The GDPR, together
  with the national legislation of the EU member states governing the processing of personal data, impose strict obligations and restrictions
  on the ability to process personal data, including health data from clinical trials and adverse event reporting. In particular, these
  obligations and restrictions concern potentially burdensome documentation requirements, granting certain rights to individuals to control
  how we collect, use, disclose, retain and process information about them, the information provided to the individuals, the transfer of
  personal data out of the EU, security breach notifications, and security and confidentiality of the personal data. The processing of sensitive
  personal data, such as physical health condition, may impose heightened compliance burdens under the GDPR and is a topic of active interest
  among foreign regulators. In addition, the GDPR provides for more robust regulatory enforcement and fines of up to €20 million
  or 4% of the annual global revenue of the noncompliant company, whichever is greater. Data protection authorities from the different EU
  member states may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of
  processing personal data in the EU. Guidance on implementation and compliance practices are often updated or otherwise revised.
  European Union
  European Union Coverage Reimbursement and Pricing
  In the European Union, pricing and reimbursement
  schemes vary widely from country to country. Some countries provide that drug products may be marketed only after a reimbursement price
  has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness of a particular drug
  candidate to currently available therapies, or so called health technology assessments, in order to obtain reimbursement or pricing approval.
  For example, the European Union provides options for its member states to restrict the range of drug products for which their national
  health insurance systems provide reimbursement and to control the prices of medicinal products for human use. European Union member states
  may approve a specific price for a drug product or may instead adopt a system of direct or indirect controls on the profitability of the
  company.
  EU Drug regulation
  In order to market any product outside of the
  United States, we would need to comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
  quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
  of our products. Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable
  foreign regulatory authorities before we can commence clinical trials or marketing of the product in foreign countries and jurisdictions
  such as in China and Japan. Although many of the issues discussed above with respect to the United States apply similarly in the
  context of the EU, the approval process varies between countries and jurisdictions and can involve additional product testing and additional
  administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from and be longer
  than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another,
  but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the regulatory process in
  others. Failure to comply with applicable foreign regulatory requirements, may be subject to, among other things, fines, suspension or
  withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
  Non-clinical studies and clinical trials
  Similarly to the United States, the various
  phases of non-clinical and clinical research in the EU are subject to significant regulatory controls.
  Non-clinical studies are performed to demonstrate
  the health or environmental safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with
  the principles of good laboratory practice (GLP) as set forth in EU Directive 2004/10/EC. In particular, non-clinical studies, both
  in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which
  define a set of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These
  GLP standards reflect the Organization for Economic Co-operation and Development requirements.
  47
  Clinical trials of medicinal products in the EU
  must be conducted in accordance with EU and national regulations and the International Conference on Harmonization (ICH) guidelines on
  good clinical practices (GCP) as well as the applicable regulatory requirements and the ethical principles that have their origin in the
  Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical
  trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint
  an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU
  member states, the sponsor is liable to provide 'no fault' compensation to any study subject injured in the clinical trial.
  Certain countries outside of the United States,
  including the EU, have a similar process that requires the submission of a clinical study application (CTA) much like the IND prior to
  the commencement of human clinical studies. A CTA must be submitted to each country's national health authority and an independent
  ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved by the national health authority and the ethics
  committee has granted a positive opinion in relation to the conduct of the trial in the relevant member state(s), in accordance with a
  country's requirements, clinical study development may proceed.
  The CTA must include, among other things, a copy
  of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
  medicinal product under investigation. Currently, CTAs must be submitted to the competent authority in each EU member state in which the
  trial will be conducted. Under the new Regulation on Clinical Trials, which is currently expected to become applicable by early 2022,
  there will be a centralized application procedure where one national authority takes the lead in reviewing the application and the other
  national authorities have only a limited involvement. Any substantial changes to the trial protocol or other information submitted with
  the CTA must be notified to or approved by the relevant competent authorities and ethics committees. Medicines used in clinical trials
  must be manufactured in accordance with good manufacturing practice (GMP). Other national and EU-wide regulatory requirements also apply.
  Marketing Authorizations
  To market a medicinal product in the EU and in
  many other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates
  can only be commercialized after obtaining a Marketing Authorization (MA). To obtain regulatory approval of an investigational medicinal
  product under EU regulatory systems, we must submit a marketing authorization application (MAA.) The process for doing this depends, among
  other things, on the nature of the medicinal product. There are two types of Mas:
  ●
  the "Union MA", which is issued by the European Commission through the Centralized Procedure, based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and which is valid throughout the entire territory of the EU. The Centralized Procedure is mandatory for certain types of products, such as (i) medicinal products derived from biotechnology medicinal products, (ii) designated orphan medicinal products, (iii) advanced therapy products (such as gene therapy, somatic cell therapy or tissue-engineered medicines), and (iv) medicinal products containing a new active substance indicated for the treatment certain diseases, such as HIV/AIDS, cancer, neurodegenerative diseases, diabetes, other auto-immune and viral diseases. The Centralized Procedure is optional for products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or that the granting of authorization would be in the interest of public health in the EU; and
  ●
  "National Mas", which are issued by the competent authorities of the EU member states and only cover their respective territory, are available for products not falling within the mandatory scope of the Centralized Procedure. Where a product has already been authorized for marketing in an EU member state, this National MA can be recognized in another member state through the Mutual Recognition Procedure. If the product has not received a National MA in any member state at the time of application, it can be approved simultaneously in various member states through the Decentralized Procedure. Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the Reference member state.
  Under the above-described procedures, in order
  to grant the MA, the EMA or the competent authorities of the EU member states make an assessment of the risk-benefit balance of the product
  on the basis of scientific criteria concerning its quality, safety and efficacy.
  48
  Under the Centralized Procedure, the maximum timeframe
  for the evaluation of a MAA by the EMA is 210 days. Where there is a major public health interest and an unmet medical need for a
  product, the CHMP may perform an accelerated review of a MA in no more than 150 days (not including clock stops). Innovative products
  that target an unmet medical need and are expected to be of major public health interest may be eligible for a number of expedited development
  and review programs, such as the PRIME scheme, which provides incentives similar to the breakthrough therapy designation in the US PRIME
  is a voluntary scheme aimed at enhancing the EMA's support for the development of medicines that target unmet medical needs. It
  is based on increased interaction and early dialogue with companies developing promising medicines, to optimize their product development
  plans and speed up their evaluation to help them reach patients earlier. Product developers that benefit from PRIME designation can expect
  to be eligible for accelerated assessment but this is not guaranteed. The benefits of a PRIME designation include the appointment of a
  CHMP rapporteur before submission of a MAA, early dialogue and scientific advice at key development milestones, and the potential to qualify
  products for accelerated review earlier in the application process.
  Mas have an initial duration of five years.
  After these five years, the authorization may be renewed for an unlimited period on the basis of a reevaluation of the risk-benefit
  balance, unless the EMA decides, on justified grounds relating to pharmacovigilance, to mandate one additional five-year renewal period.
  Data and marketing exclusivity
  The EU also provides opportunities for market
  exclusivity. Upon receiving MA, new chemical entity, or reference product candidates, generally receive eight years of data exclusivity
  and an additional two years of market exclusivity. If granted, the data exclusivity period prevents generic or biosimilar applicants
  from relying on the pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic
  or biosimilar MA in the EU during a period of eight years from the date on which the reference product was first authorized in the
  EU. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product in the EU
  until 10 years have elapsed from the initial authorization of the reference product in the EU. The overall 10-year market exclusivity
  period can be extended to a maximum of eleven years if, during the first eight years of those 10 years, the MA holder obtains
  an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are
  held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee that a product will
  be considered by the EU's regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity.
  Pediatric Development
  In the EU, MAAs for new medicinal products candidates
  have to include the results of trials conducted in the pediatric population, in compliance with a pediatric investigation plan (PIP) agreed
  with the EMA's Pediatric Committee (PDCO). The PIP sets out the timing and measures proposed to generate data to support a pediatric
  indication of the drug for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures
  of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to
  provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely
  to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations,
  or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA
  is obtained in all EU Member States and study results are included in the product information, even when negative, the product is eligible
  for six months' supplementary protection certificate extension (if any is in effect at the time of authorization).
  49
  Post-Approval Requirements
  Similar to the United States, both MA holders
  and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the
  competent regulatory authorities of the member states. The holder of a MA must establish and maintain a pharmacovigilance system and appoint
  an individual qualified person for pharmacovigilance who is responsible for oversight of that system. Key obligations include expedited
  reporting of suspected serious adverse reactions and submission of periodic safety update reports (PSURs).
  All new MAA must include a risk management plan
  (RMP) describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks
  associated with the product. The regulatory authorities may also impose specific obligations as a condition of the MA. Such risk-minimization
  measures or post-authorization obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct
  of additional clinical trials or post-authorization safety studies.
  The advertising and promotion of medicinal products
  is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
  and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
  of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
  is also prohibited in the EU. Although general requirements for advertising and promotion of medicinal products are established under
  EU directives, the details are governed by regulations in each member state and can differ from one country to another.
  The aforementioned EU rules are generally applicable
  in the European Economic Area (EEA) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.
  For other countries outside of the EU, such as
  countries in Latin America or Asia (e.g. China and Japan), the requirements governing the conduct of clinical studies, product licensing,
  pricing and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP
  and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki. If we fail
  to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of
  regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
  Privacy and data protection laws
  We are also subject to laws and regulations in
  non-US countries covering data privacy and the protection of health-related and other personal information. For instance, EU member states
  and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations. Laws and regulations
  in these jurisdictions apply broadly to the collection, use, storage, disclosure, processing and security of personal information that
  identifies or may be used to identify an individual, such as names, contact information, and sensitive personal data such as health data.
  These laws and regulations are subject to frequent revisions and differing interpretations,
  As of May 2018, the General Data Protection
  Regulation (GDPR) replaced the Data Protection Directive with respect to the processing of personal data in the European Union. The GDPR
  imposes many requirements for controllers and processors of personal data, including, for example, higher standards for obtaining consent
  from individuals to process their personal data, more robust disclosures to individuals and a strengthened individual data rights regime,
  shortened timelines for data breach notifications, limitations on retention and secondary use of information, increased requirements pertaining
  to health data and pseudonymised (i.e., key-coded) data and additional obligations when we contract third-party processors in connection
  with the processing of the personal data. The GDPR allows EU member states to make additional laws and regulations further limiting the
  processing of genetic, biometric or health data. Failure to comply with the requirements of GDPR and the applicable national data protection
  laws of the EU member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
  financial year, whichever is higher, and other administrative penalties.
  50
  Japan
  Japanese drug regulation
  Non-clinical studies and clinical trials
  Being a member of the International Conference
  on Harmonization (ICH), Japan has pharmaceutical regulations fundamentally similar to those of the United States or EU.
  Non-clinical studies are performed to demonstrate
  the health safety of new chemical or biological substances. Non-clinical studies must be conducted in compliance with the principles of
  Japanese good laboratory practice (GLP) which reflect the Organization for Economic Co-operation and Development requirements. Currently,
  Japan and EU have a mutual recognition agreement for GLP, and data generated compliant with EU requirements will be accepted by the Japanese
  authorities. There is no similar agreement with the United States.
  Clinical trials of medicinal products in Japan
  must be conducted in accordance with Japanese regulations based on ICH guidelines governing good clinical practices (GCP). They focus
  on ethics of the clinical trial and protection of the privacy of the trial subjects. If the sponsor of the clinical trial is not established
  within Japan, it must appoint an entity within the country to act as its caretaker who should be authorized to act on the sponsor's
  behalf. The sponsor must take out a clinical trial insurance policy, and, according to the industry agreement, should put in place a common
  compensation policy for the injuries from the trial.
  Prior to the commencement of human clinical studies,
  the sponsor must complete evaluation of the safety of the investigative product, and submit a clinical trial notification and the protocol
  to the authorities in advance, upon agreement of the IRB of the participating institutions. When the authorities do not comment on the
  notification, the sponsor may proceed with the clinical trial.
  Any substantial changes to the trial protocol
  or other information submitted must be cleared by the IRB and notified to the authorities. Medicines used in clinical trials must be manufactured
  in accordance with good manufacturing practice (GMP).
  Product approval
  To market a medicinal product in Japan, we must
  obtain regulatory approval. To obtain regulatory approval of an investigational medicinal product, we must submit a new drug application.
  The process for doing this depends, among other things, on the nature of the medicinal product and there are currently a few different
  pathways for approval. If the product is designed for treating certain "difficult diseases" or those whose patient size is
  limited, we may be able to obtain designation as an orphan drug product if it demonstrates unique therapeutic value. Approval application
  for such designated orphan products will be processed on an expedited basis and the authorities' requirement for clinical data will
  be much limited. Separately, the latest amendment to the law introduced separate pathways for (i) truly innovative products with
  a unique mode of action and (ii) those which will satisfy unmet medical needs. These products will also be processed on an expedited
  basis.
  The evaluation of applications will be based on
  an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy.
  Once the review organization complete its review task, the matter will be considered by the advisory committee of experts, and the government
  will grant approval upon positive recommendation from the committee.
  The volume and quality of the clinical data will
  be the key determinant of the approval decision. Clinical trial data generated overseas will be accepted as part of the data package consistent
  with the ICH recommendation. Typically, a limited dose response clinical trial for Japanese subjects is required to ensure that data are
  extrapolatable for the Japanese population. In a more recent development, the authorities encourage manufacturers to organize an international
  joint clinical trial with some Japanese participation under a joint protocol, to expedite the clinical trial process. Regulatory approval
  does not expire.
  51
  Licensing requirement
  Separate from the approval requirement, it is
  also mandatory to possess a distribution license of an appropriate class for the manufacturer to commercially distribute the product in
  Japan. Non-Japanese companies who possess only the product approval may designate an appropriate license holder in Japan to commercially
  distribute the product, rather than distributing it on its own. The license is valid for 5 years.
  Intellectual Property
  Exclusive License Agreement with Children's Hospital Medical
  Center, d/b/a Cincinnati Children's Hospital Medical Center
  On June 1, 2021 (the "Effective Date"),
  the Company entered into a license agreement with Children's Hospital Medical Center, d/b/a Cincinnati Children's Hospital
  Medical Center ("CHMC") to develop and commercialize certain CHMC patents and related technology directed at a virus-like
  particle (VLP) vaccine platform that utilizes nanoparticle delivery technology, which may have potential broad application to develop
  vaccines for multiple infectious diseases ("the CHMC Agreement"). The license is exclusive, worldwide, and is for all uses
  (other than the "Excluded Field" of immunization against, and prevention, control, or reduction in severity of gastroenteritis
  caused by Rotavirus and Norovirus in China and Hong Kong). The license is sublicensable with prior CHMC written approval consistent
  with the terms of the CHMC Agreement.
  The CHMC Agreement includes the below patents,
  which we refer to as the "Licensed Patents", and any divisionals, continuations and continuations-in-part thereto (solely
  to the extent that the claims in the continuations-in-part are directed to the subject matter specifically claimed in the Licensed Patents,
  and they have the same priority date as the Licensed Patents, but do not include any different or additional claims), and any patents
  resulting therefrom:
  U.S. Patent
  Application No.
  U.S.
  Patent
  No.
  Granted Claim Type
  U.S.
  Expiration
  Foreign Counterparts
  12/797,396
  8,486,421
  Compositions of the vaccine/vaccine platform
  1/13/2031
  CN107043408B EP2440582B1 JP5894528B2
  13/924,906
  9,096,644
  Method of treatment
  9/20/2030
  CN107043408B EP2440582B1 JP5894528B2
  13/803,057
  9,562,077
  Compositions of the vaccine platform
  11/8/2033
  none
  16/489,095
  pending
  pending**
  [3/15/2038]*
  Pending applications in Canada, China, EU and Japan
  63/149,742 (filed 2/16/2021)
  pending
  pending**
  [February 2042]
  #
  TBD
  63/162,369 (filed 3/17/2021)
  pending
  pending**
  [March 2042]
  #
  TBD
  *
  Projected expiration if patent issues: 20 years from earliest non-provisional application filing date.
  #
  Non-provisional application not yet filed. Expiration projected 21 years from provisional application filing date. Dependent on timely conversion to non-provisional application and issuance of patent.
  **
  This is a pending application. Claim type will be determined after U.S. prosecution is complete. The claim type sought includes compositions of the vaccine and vaccine platform.
  52
  The CHMC Agreement also grants the Company a non-exclusive
  limited license to use and copy internally any technical information in existence and known before the Effective Date by CHMC solely as
  necessary for the use and practice of the Licensed Patents (the "Technology").
  The term of the CHMC Agreement begins on the Effective
  Date and extends on a jurisdiction by jurisdiction and product by product basis until the later of: (i) the last to expire Licensed
  Patent; (ii) ten (10) years after the first commercial sale; or, (iii) entrance onto the market of a biosimilar or interchangeable
  product. CHMC has reserved the right to practice, have practiced, and transfer the Licensed Patents and Technology for research and development
  purposes, including education, research, teaching, publication and public service, but not to use or practice the Licensed Patents or
  Technology in Field of Use for any commercial or profit purpose.
  The Licensed Patents granted to the Company under
  the CHMC Agreement are also subject to any rights of the United States federal, state and/or local Government(s), as well as nonprofit
  entities, if certain patents or technologies were created in the course of Government-funded or non-profit entity-funded research. The
  CHMC Agreement also contains compulsory licensing provisions under which CHMC must notify the Company in writing whenever CHMC may become
  aware of third parties that are interested in obtaining rights to the Licensed Patents or Technology for purposes that are beyond the
  scope of the Company's development and commercialization plan. The Company may elect to pursue the new purposes itself (and negotiate
  commercially reasonable development targets), or enter into sublicense negotiations with the interested third party. However, if the Company
  fails to meet its development targets for the new purposes or fails to enter into a sublicense agreement with the interested third party
  within nine (9) months of the notice from CHMC, then the new purpose will be excluded from the license grant and CHMC will be free
  to pursue licensing of the Licensed Patents or Technology within the Excluded Field to an interested third party.
  Any patented modification, alteration or improvement
  of any invention claimed in a Licensed Patents or Technology which is conceived or reduced to practice solely by the Company ("Company
  Improvement") is owned by the Company; however, for any such Company Improvement, the Company will automatically grant to CHMC a
  worldwide, perpetual, sublicensable, nonexclusive, paid-up, royalty-free license to use any Company Improvements solely for clinical or
  non-clinical, non-commercial research, testing, educational and patient care purposes. The CHMC Agreement also provides the Company with
  an option to license any CHMC or jointly patented modification, alteration or improvement of any invention claimed in a Licensed Patent
  ("CHMC Improvement" and "Joint Improvement, respectively"), with option fee for each Improvement that the Company
  elects to include in the license grant of the CHMC Agreement.
  The Company is required to pay CHMC an aggregate
  of up to $59.75 million upon the achievement of specified development milestones, of approximately $0.5 million, regulatory
  milestones, of approximately $1.25 million and commercial milestones, of approximately $58 million (excluding any royalty arrangements).
  In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the Company is obligated
  to pay CHMC a percentage of all non-royalty sublicensing revenue. Specifically, the Company must pay twenty-five percent (25%) for revenue
  received from the sublicensee prior to first net sale of a licensed product, fifteen percent (15%) for revenue received after first net
  sale of a licensed product or five percent after the first sale of a second licensed product. No annual maintenance fee is required.
  Pursuant to the CHMC Agreement, the Company paid
  to CHMC a one-time $25,000 initial license fee; thereafter, the Company is required to pay $100,000 deferred license fee upon the earlier
  of the Company's first to occur convertible debt or equity raise after the Effective Date. On the one year anniversary of the Effective
  Date, the Company will be required to pay to CHMC an additional deferred $100,000 license fee.
  Under the CHMC Agreement, the Company is obligated
  to use commercially reasonable efforts to bring licensed products to market through diligent research and development, testing, manufacturing
  and commercialization and to use best efforts to make all necessary regulatory filings and obtain all necessary regulatory approvals,
  and achieve milestones relating to development and sales, and report to CHMC on progress. The Company will also be obligated to pay the
  agreed upon development milestone payments to CHMC.
  53
  Development milestones include: (i) IND filings
  of each Licensed Product; (ii) BLA or equivalent allowed for Licensed Product in U.S. or E.U.; (iii) first commercial sale
  of licensed product in the U.S.; (iv) first commercial sale of licensed product in the E.U.; (v) first commercial sale of licensed
  product in Japan; (vi) first commercial sale in Rest of World (ROW); (vii) conclusion of the first calendar year. Pursuant to
  the terms of the CHMC Agreement, if the Company fails to achieve milestones or make milestone payments on certain milestones, and cannot
  mutually agree with CHMC on an amendment to the milestones, then CHMC will have the option of converting any and all of such exclusive
  licenses to nonexclusive licenses.
  In addition to the fees discussed above, beginning
  on the first Net Sale, the Company will pay CHMC running royalties on a quarterly basis as a percentage of Net Sales (as defined in the
  CHMC Agreement) of the Company, its affiliates and any subsidiaries. Similarly, in the event the Company enters into a sublicense agreement,
  the Company shall pay CHMC a percentage of all non-royalty sublicensing revenues received from the sublicensee. There is a 5% royalty
  rate for products and processes for P-Particle VLP Bivalent vaccine for norovirus and rotavirus; a 4% royalty rate for products and processes
  for Universal Flu Vaccine(s); and a 2% royalty rate for all other products or processes for other indications. To date, no payments have
  been made related to the milestones or royalties. Before any Valid Claims (as defined in the CHMC Agreement) exist, the running royalty
  rates are reduced by fifty percent (50%).
  The CHMC Agreement also contains an anti-stacking
  provision pursuant to which in the event the Company is legally required to pay royalties to one or more third parties whose patent rights
  dominate the Licensed Patents, and would therefore be infringed by exercise of the license rights granted in the CHMC Agreement, the Company
  may reduce running royalty payments by fifty percent (50%). In the event the Company grants sublicenses, the Company is obligated to pay
  CHMC as follows: (i) specified percentage of revenue received prior to first Net Sale of first Licensed Product; (ii) specified
  percentage for revenue received after first Net Sales of first Licensed Product but before first Net Sales of second Licensed Product;
  or (iii) specified percentage for revenues received after first Net Sales of second Licensed Product.
  CHMC reserved the first and sole right, using
  in-house or outside legal counsel selected by CHMC, to prepare, file, prosecute, maintain and extend patents and patent applications,
  and the Company agreed to reimburse CHMC for its legal and administrative costs incurred in the course of doing such. The Company also
  agreed to reimburse CHMC for incurred legal fees of approximately $177,100 as of the Effective Date. CHMC will provide the Company a reasonable
  opportunity to comment during prosecution and will consider the Company's comments, but CHMC retained control over all final decisions.
  If CHMC elects to not be responsible for the prosecution or maintenance of any such patents, the Company will receive a sixty (60) days'
  written notice upon which the Company may elect, at the Company's expense, to assume the responsibilities and obligations to prosecute
  and maintain the patents (among other things); thereafter, the Company will use reasonable efforts to give CHMC an opportunity to comment,
  but the final decision with respect to such matter will remain with the Company.
  The CHMC Agreement contains no CHMC representations
  or warranties. The CHMC Agreement also requires the Company to indemnify CHMC and other related parties against all claims, suit, actions,
  demands, judgments, or investigations arising out of any product the Company produces under the CHMC Agreement, as set forth in the CHMC
  Agreement, and requires the Company, beginning with the earlier of the first clinical trial or commercial sale or other commercialization
  to obtain liability insurance.
  CHMC will have the first and sole right but not
  the obligation, at its own expense, to initiate an infringement suit or other appropriate actions against third party infringers and receives
  all therefrom. For joint suits initiated against third party infringers and receives damages or profits recovered therefrom. In the event
  CHMC does not, within six (6) months after becoming aware of infringement, secure cessation of the infringement, the Company will
  have the right to initiate suit at its own expense. Any damages or profits that the Company recovers will be treated as Net Sales subject
  to royalties after the Company has been compensated for its costs in handling such action. In the event of a joint infringement suit,
  the Company and CHMC will agree in writing who will control the action and how cost and recoveries will be shared.
  54
  The Company may terminate the CHMC Agreement for
  convenience, at any time prior to first commercial sale of a product or process by providing one hundred and eighty (180) days'
  written notice to CHMC. It may also terminate for a CHMC uncured material breach. CHMC may terminate the CHMC Agreement for an uncured
  Company material breach or insolvency or bankruptcy. In the event the Company's material breach is for failure to meet any of the
  milestone payments, the Company is entitled to a nonexclusive license to continue developing indications that have already entered development
  at any stage or in which the Company has invested in developing. CHMC may also terminate the CHMC Agreement to the fullest extent permitted
  by law in the countries of the worldwide territory, in the event the Company or its affiliates challenge or induce others set up challenges
  to the validity or enforceability of any of the Licensed Patents and the Company will be obligated reimburse CHMC for its costs, including
  reasonable attorneys' fees.
  Option Agreement between Oxford University Innovation Limited
  and Blue Water Vaccines Inc.
  On December 18, 2018, the Company entered
  into an option agreement with Oxford University Innovation Limited ("OUI"), pursuant to which the Company paid an option fee
  of between $25,000, to OUI in exchange for a period of exclusivity, in advance of a fundraising of fifteen million dollars ($15,000,000).
  Under the option agreement, the Company has the right to exercise the option for the grant of the right to the Company to an exclusive,
  worldwide license to PCT Patent Application number PCT/GB/2017/052510, any patents granted in response to that application, any corresponding
  foreign patents and applications deriving priority from that application, and any addition, continuation, continuation-in-part, division,
  reissue, renewal or extension based thereon, and related know-how and confidential information (the "Technology").
  Exercise of the option by the Company was conditional
  upon the Company submitting a business plan for the subsequent two years, including a development plan for the technology and a financial
  projection, demonstrating the Company's ability to develop the Technology and evidence of the Company's solvency and receipt
  of fifteen million dollars ($15,000,000) in funds for the development of the Technology. The Company has agreed that, as a condition precedent
  to the license becoming effective, it must provide funding for three years of salary for Dr. Craig Thompson in Oxford's
  Department of Zoology of four hundred and twenty thousand pounds (£420,000). No additional funds are required to fulfill the three-year
  salary commitment, at this time, and none are anticipated prior to the completion of the three year term.
  License Agreement between Oxford University Innovation Limited
  and Blue Water Vaccines Inc.
  On July 16, 2019, the Company entered into
  an exclusive, worldwide agreement ("OUI Agreement") with Oxford University Innovation Limited ("OUI"), pursuant
  to which the Company obtained an exclusive worldwide license for all fields to PCT Patent Application number PCT/GB/2017/052510, entitled
  "Immunogenic Composition," any patents granted in response to that application, any corresponding foreign patents and applications
  deriving priority from that application, and any addition, continuation, continuation-in-part, division, reissue, renewal or extension
  based thereon, and a nonexclusive license to related know-how and confidential information, as set forth in the below chart (the "Licensed
  Technology"):
  U.S. Patent
  Application No.
  U.S. Patent No.
  Granted Claim Type
  U.S. Expiration
  Foreign Counterparts
  16/326,749
  11,123,422
  Compositions and method of treatment
  8/25/2037
  Pending applications in Australia, Canada, China, EU and Japan
  17/458,712
  pending
  pending**
  [8/25/2037]*
  *
  Projected expiration if patent issues: 20 years from earliest non-provisional application filing date.
  **
  This is a pending application. Claim type will be determined after U.S. prosecution is complete. The claim type sought includes compositions of the compositions and method of treatment.
  The OUI Agreement has a term concluding ten years
  following the last to expire of all licensed patents and patent applications as defined under the terms of the OUI Agreement. The license
  was conditional upon the Company entering into a separate agreement with Oxford University to provide funding for three years'
  salary for Dr. Craig Thompson in the University's Department of Zoology, which amounted to four hundred and twenty thousand
  pounds (£420,000), which was paid by the Company in January 2020. No additional funds are required to fulfill the three-year
  salary commitment, at this time, and none are anticipated prior to the completion of the three year term.
  55
  Improvements to the Licensed Technology as defined
  in the OUI Agreement belong to OUI and are included in the Licensed Technology. All Company Improvements of belong to the Company. The
  Company granted to OUI, and OUI subsequently granted to Oxford University, a non-transferable, irrevocable, perpetual, royalty-free license
  to use and publish the Licensed Technology and the Company's Improvements upon the Licensed Technology for non-commercial use. If
  a Licensed Product is covered by the Medicines Access Policy of Oxford University to promote, the Company shall adhere to the requirements
  of the Medicines Access Policy.
  The Company is required to pay OUI milestone payments
  of up to an aggregate of $51 million upon the achievement of specified development milestones, of approximately $2.25 million,
  regulatory milestones, of approximately $9.5 million and commercial milestones, of approximately $39.5 million (excluding any
  royalty arrangements). An annual maintenance fee, or minimum sum, $10,000 to $20,000 will be required beginning in 2023 through launch,
  increasing to $250,000, which would be the highest "minimum sum" of royalties in any year prior until expiration or revocation
  of the last valid claim covering a licensed product, in which case the annual maintenance fee will no longer be required and the "step
  down" royalty rate will apply.
  The Company did not pay a signing fee to OUI and
  is obligated to pay a 6% royalty on all net sales of licensed products, as defined in the OUI Agreement, as well as royalties between
  25% on any sums received by the Company from any sublicensee (including all up-front, milestone and other one-off payments received by
  the Company from any sub-licenses or other contracts granted by the Company with respect to the licensed technology). After the expiration
  or revocation of the last Valid Claim (as defined in the OUI Agreement) covering a Licensed Product, a "step down" royalty
  rate shall apply to such Licensed Technology and no minimum sum will be payable by the Company. If the Company has to pay royalties to
  a third party to use a proprietary manufacturing process proprietary adjuvants in order to make or have made a Licensed Product, the Company
  will be able to deduct from all royalty payments, up to a maximum amount of twenty-five percent (25%) of the royalties due to OUI. The
  OUI Agreement entitles the Company to supply a commercially reasonable quantity (not exceeding 5% of units sold in any quarter) of licensed
  products for promotional sampling.
  In the event that royalties paid to OUI do not
  amount to the "minimum sum", as discussed above, under the OUI Agreement for a particular year, the Company is obligated to
  make up the difference between the royalties actually paid and such minimum sum. The minimum sums vary over time, and reduces to $0 once
  the "step down" applies. The minimum sums and milestone fees are indexed to the RPI (Retail Prices index for all items which
  is published in the United Kingdom by the Office for National Statistics, or any replacement of it) and will be increased or decreased
  as appropriate as set forth in the OUI Agreement.
  The Company is obligated to use its best efforts
  to develop and market Licensed Products in accordance with its development plan report to OUI on progress and achieve the following milestones
  and must pay OUI nonrefundable milestone fees as follows when it achieves them: initiation of first Phase I study; initiation of
  first Phase II study; initiation of first Phase III/pivotal registration studies; first submission of application for regulatory
  approval (BLA/NDA); marketing authorization in the United States; marketing authorization in any EU country; marketing authorization
  in Japan; first marketing authorization in any other country; first commercial sale in Japan; first commercial sale in any ROW country;
  first year that annual sales equal or exceed certain thresholds.
  The Company is obligated to pay, and has paid,
  £11,323 to OUI for any past patent expenses that were incurred prior to the execution of the OUI Agreement. Upon consultation with
  the Company and at the Company's expense, OUI shall prosecute, use all reasonable endeavors to maintain and renew the patents throughout
  the duration of the OUI Agreement. The Company and OUI agreed to inform each other in writing of any misappropriation or infringement
  of any rights to the licensed technology; however, the Company has the first right to take legal action at its own cost in relation to
  any such misappropriation or infringement, but must discuss any proposed legal action with OUI and take into account any legitimate interest
  of OUI in the legal action that it takes. If the Company notifies OUI that it does not intend to take legal action in such matters, OUI
  may take any legal action at its own cost. All profits or damages recovered after unrecovered costs and expenses are deducted are treated
  as net sales for which royalties would be due.
  OUI makes no warranties at all with regard to
  the Licensed Technology or whether use of it will infringe third party rights. The Company is required to indemnify OUI and Oxford University
  from all third party claims, damages, and liabilities asserted by third parties arising directly or indirectly from use of the Licensed
  Technology; marketing of Licensed Products; or breach of the OUI Agreement. The OUI Agreement is governed by English law and the parties
  agreed to submit to the exclusive jurisdiction of English Courts for resolution of any disputes arising out of or in connection with the
  OUI Agreement, with the exception of actions relating to intellectual property disputes or confidential information which may be brought
  in any court of competent jurisdiction.
  56
  Either party may terminate the OUI Agreement for
  an uncured material breach. The Company may terminate the OUI Agreement for any reason at any time upon six months' written
  notice expiring after the third anniversary of the OUI Agreement. OUI may terminate immediately if the Company has a petition presented
  for its winding-up or passes a resolution for winding up other than for a bona fide amalgamation or reconstruction or compounds with its
  creditors or has a receiver or administrator appointed. OUI may also terminate if the Company opposes or challenges the validity of any
  of the patents or applications in the Licensed Technology; raises the claim that the know-how of the Licensed Technology is not necessary
  to develop and market Licensed Products; or in OUI's reasonable opinion, is taking inadequate or insufficient steps develop or market
  Licensed Products and does not take any further steps that OUI requests by written notice within a reasonable time.
  Pursuant
  to the terms of the OUI Agreement, the Company entered into a sponsored research agreement (the "OUI SRA"), dated December 18,
  2019 with Oxford University for research related to the OUI Agreement for a period of three years for a total of £420,000.
  The Company prepaid the full amount to Oxford of $554,802 for the services in January 2020.
  Pursuant to an amendment
  to the SRA (the "OUI SRA Amendment"), dated May 16, 2022, the term of the research under the SRA was extended for an additional
  18 months, culminating on June 18, 2024. The OUI SRA Amendment also requires that the Company provide additional funding in connection
  with the research in the amount of £53,500.
  Exclusive License Agreement between St. Jude Children's
  Research Hospital, Inc. & Blue Water Vaccines Inc.
  On January 27, 2020 (the "Effective
  Date"), the Company entered into an exclusive, worldwide license agreement with St. Jude Children's Research Hospital, Inc.
  ("St. Jude"), pursuant to which St. Jude granted the Company an exclusive license to develop licensed products and produce
  vaccines for use in humans ("St. Jude Agreement") under U.S. Provisional Patent Application No. 61/537,290 (U.S. Patent
  No. 9,265,819 issued on February 23, 2016), and U.S. Provisional Patent Application No. 62/817,748 (filed March 13, 2019),
  and any issued patents, divisions, continuations, continuations-in-part, to the extent that the claims are directed to subject matter
  described in the above-referenced patent applications and are entitled to the priority date of the existing patent rights, re-examinations,
  substitutions, renewals, restorations, additions, or registrations thereof, as well as non-United States counterparts thereof, and
  extensions and supplementary protection certificates thereon ("Patent Rights"), all as set forth in the below chart:
  U.S. Patent
  Application No.
  U.S. Patent No.
  Granted Claim Type
  U.S. Expiration
  Foreign Counterparts
  14/345,988
  9,265,819
  Compositions and method of treatment
  9/19/2032
  none
  17/602,414
  #
  pending
  pending**
  [3/12/2040]*
  Pending Applications in:
  Australia,
  Brazil, Canada, China, Europe,
  Hong Kong, Japan and Korea
  *
  Projected expiration if patent issues: 20 years from earliest non-provisional application filing date.
  #
  U.S. National stage entry of WO 2020/183420 (PCT/IB2020/052250).
  **
  This is a pending application. Claim type will be determined after U.S. prosecution is complete. The claim type sought includes compositions and method of treatment.
  The license is sublicensable consistent with the
  terms and conditions of the St. Jude Agreement, provided that the Company remains responsible for the performance by each of its sublicensees.
  The license is subject to any government rights the United States has reserved, and St. Jude retained the right to make, have made,
  provide and use for St. Jude's non-commercial research and clinical purposes, including the right to distribute St. Jude's
  biological material disclosed and claimed in the Patent Rights for non-profit academic research use to non-commercial entities as is customary
  in the scientific community and to sell the biological materials as research reagents for research use only by the scientific community.
  57
  The Company is required to pay St. Jude milestone
  payments of up to an aggregate of $1.0 million upon the achievement of specified development milestones, of approximately $0.2 million,
  regulatory milestones, of approximately $0.3 million and commercial milestones, of approximately $0.5 million (excluding any
  royalty arrangements). In the event the Company enters into a sublicense agreement with a third party who is not an affiliate, then the
  Company is obligated to pay St. Jude fifteen percent of any sublicense consideration, subject to specified exclusions, but including any
  upfront or milestone fees and including any premium paid by sublicensee over Fair Market Value (as defined in the agreement) for the Company's
  stock.
  In exchange for the licenses, the Company paid
  St. Jude an initial license fee of $15,000 and is required to pay an annual maintenance fee of $10,000 beginning on the first anniversary
  of the Effective Date (which is waived if all of the developmental milestones scheduled for completion before such annual fee is due have
  been achieved), milestone payments, patent reimbursement, and running royalties based on net sales of licensed products under the St.
  Jude Agreement.
  Under the St. Jude Agreement, the Company is obligated
  to use commercially reasonable efforts to develop and commercialize the licensed product(s). If the Company fails to achieve the development
  milestones contained in the St. Jude Agreement, and if the Company and St. Jude fail to agree upon a mutually satisfactory revised time
  line, St. Jude will have the right to terminate the St. Jude Agreement.
  The milestones include the following events: (i) complete
  IND enabling study by 2020; (ii) Initiate animal toxicology study by last half of 2020; (iii) file IND by first half of 2021;
  (iv) complete Phase I Clinical Trial by first half of 2022; (v) commence Phase II Clinical Trial by first half of
  2024; (vi) commence Phase III Clinical Trial by 2026; and, (vii) regulatory approval, U.S. or foreign equivalent by
  2026. Upon achievement of certain development and commercialization milestones, the Company is required to make milestone payments to
  St. Jude between the achievement of certain milestones (commencement of a Phase III clinical trial through first commercial sale).
  Additionally, the Company is obligated to make
  running 4% royalty payments payable, for each licensed product(s) sold by the Company, its affiliates or sublicensees, based on the
  net sales for the duration of the St. Jude Agreement. Furthermore, the Company is obligated to pay a percentage between 15% of other consideration
  received for any sublicenses.
  On May 11, 2022, the Company and St. Jude entered
  into a first amendment to the St. Jude Agreement (the "St. Jude Amendment"). The St. Jude Amendment provides for a revised
  development milestone timeline, a one-time license fee of $5,000, and an increase to the royalty rate from 4% to 5%. The St. Jude Amendment
  also provides for an increase to the contingent milestone payments, from $1.0 million to $1.9 million in the aggregate; specifically,
  development milestones of $0.3 million, regulatory milestones of $0.6 million, and commercial milestones of $1.0 million.
  The Company reimbursed St. Jude approximately
  $32,400 for certain patent costs incurred by St. Jude prior to the Effective Date of the St. Jude Agreement, and is obligated to reimburse
  St. Jude for reasonable patent costs incurred by St. Jude subsequent to the Effective Date.
  The Company is responsible for and shall bear
  all expenses relating to the filing, prosecution, and maintenance of all patent rights licensed under the St. Jude Agreement. The Company
  has the first right to enforce any patent against infringement, and shall keep St. Jude informed of the status of such; however, before
  the Company may commence any action with respect to any such alleged infringement, the Company shall take into consideration the views
  of St. Jude and the potential effect on the public interest.
  Prior to initial human testing or first commercial
  sale of a licensed product, and thereafter so long as the licensed products are being sold in any particular country, the Company (and
  its sublicenses) is required to obtain and maintain insurance to cover its indemnity obligations, and to obtain and maintain product liability
  insurance coverage.
  58
  St. Jude represented and warranted that it has
  good and marketable title to the Patent Rights, but made no other representations and warranties. The term of the agreement commenced
  on the Effective Date, and shall continue, in each country, until the date of expiration of the last to expire valid claim included within
  the Patent Rights in that country. Either party may terminate the St. Jude Agreement in the event the other party (a) files or has
  filed against it a petition under the Bankruptcy Act (among other things) or (b) fails to perform or otherwise breaches its obligations
  under the St. Jude Agreement, and has not cured such failure or breach within sixty (60) days. The Company may terminate for any
  reason on thirty (30) days written notice.
  In addition to the St. Jude Agreement, the Company
  also entered into a sponsored research agreement (the "SRA") dated May 3, 2021 with St. Jude for research related to
  the St. Jude Agreement. Pursuant to the SRA, the Company is obligated to pay St. Jude an aggregate amount of $73,073 in two parts, Phase I
  for $57,624 and Phase II for $15,449 and this sponsored research project began during the year ended December 31, 2021.
  Manufacturing and Supply
  We currently do not own or operate any manufacturing
  facilities, but our strategic partnership with Ology Bioservices, Inc. (which was later acquired by National Resilience, Inc.) ("Ology")
  provides us with access to substantial resources to facilitate an independent supply path to the market. Ology is a leading global contract
  manufacturer with deep domain expertise and experience in large and small-scale production of clinical, as well as commercial-stage products.
  We have entered into agreements with Ology to secure capacity, technical expertise and resources to support the production of our products
  and processes that are intended to scale to commercial scale at Ology or other commercial manufacturing sites.
  In July 2019, we entered into a development
  and manufacturing master services agreement with Ology, which we refer to, as amended, as the Ology Agreement, pursuant to which Ology
  is obligated to perform manufacturing process development and clinical manufacture and supply of components.
  Under the Ology Agreement, we will pay Ology agreed
  upon fees for Ology's performance of manufacturing services, and we will reimburse Ology for its out-of-pocket costs associated
  with purchasing raw materials, plus a customary handling fee. The Company entered into an initial Project Addendum on October 18,
  2019 and the Company was required to pay Ology an aggregate of approximately $4 million. Due to unforeseen delays associated with
  COVID-19, the Company and Resilience entered into a letter agreement dated January 9, 2020 to stop work on the project. The Company
  paid Ology $100,000 for services, of which $48,600 remains as prepaid expense as of December 31, 2020. The second Project Addendum
  was executed May 21, 2021 and the Company is obligated to pay Ology an aggregate amount of approximately $2.8 million, plus
  reimbursement for materials and outsourced testing, which will be billed at cost plus 15%. This project began during the year ended December 31,
  2021, and the Company has incurred related research and development expenses of approximately $328,000 of which approximately $164,000
  and $115,000 was recorded as accounts payable and accrued expenses, respectively, at December 31, 2021. During the three months ended
  March 31, 2022, the Company incurred related research and development expenses of approximately $217,000, and had approximately $332,000
  recorded as related accrued expenses at March 31, 2022.
  On April 20, 2022, the Company and Ology entered
  into a first amendment to the second Project Addendum (the "Ology Amendment"). The Ology Amendment provides for an increase
  to the Company's obligation of $0.3 million, specifically related to regulatory support on the project.
  Either party may terminate a Project Addendum
  and/or the Ology Agreement upon the material breach of any provision of this Agreement by the other Party if such breach is not cured
  by the breaching party within thirty (30) calendar days after receipt by the breaching Party of written notice of such
  default. The Company may terminate the Ology Agreement or the associated Project Addendum for any or no reason upon sixty (60) days'
  prior written notice to Ology.
  59
  Employees
  As of May 20, 2022, we had 5 full-time and 7 subcontracted
  employees. None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage.
  We believe we have good relations with our employees.
  Properties and Facilities
  We are currently leasing an office located at
  201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis. All of our research and development is
  performed on the premises of our third-party providers.
  Legal Proceedings
  On April 15, 2022, the Company received a demand
  letter (the "Demand Letter") from Boustead. The Demand Letter alleges that the Company breached the Underwriting Agreement
  entered into between Boustead Securities, LLC ("Boustead") and the Company, dated February 17, 2022 (the "Underwriting
  Agreement") in connection with the Company's initial public offering. The Demand Letter alleges that, by engaging H.C. Wainwright
  & Co., LLC as placement agent in the Company's private placement, consummated in April 2022 (the "Private Placement"),
  the Company breached the right of first refusal to act as placement agent granted to Boustead under the Underwriting Agreement and, as
  a result of selling securities in the Private Placement, breached the 12-month lock-up obligation following the consummation of the initial
  public offering under the Underwriting Agreement. The Demand Letter requested that the Company rescind the Private Placement. The Company
  has not responded to the Demand Letter and no legal action has been brought by Boustead to date. There can be no assurance as to whether
  any litigation will be commenced against the Company with respect to the demand letter or that, if any such litigation is commenced, the
  Company will not incur material losses due to damages, penalties, costs and/or expenses as a result of such litigation or that any such
  losses will not have a material impact on the Company's financial condition or results of operations.
  Summary Risk Factors
  Our business is subject to
  a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial
  condition, results of operations, cash flows and prospects that you should consider before making a decision to invest in our common stock.
  These risks include, but are not limited to, the following:
  ●
  We are in the early stages of vaccine development and have a very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  ●
  We have incurred significant net losses since inception, do not generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability. Our stock is a highly speculative investment.
  ●
  We will require significant additional capital to make the investments we need to execute our longer-term business plan. We estimate that, based on our existing cash as of the date of this registration statement, we have cash on hand sufficient to fund our operations for at least the next 12 months. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations, and we may be unable to continue as a going concern in the long term. If we cannot continue as a viable entity, our stockholders may lose some or all of their investment in us.
  ●
  Due to the significant resources required for the development of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates. Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine candidates that may be more profitable or for which there is a greater likelihood of success.
  60
  ●
  We depend entirely on the success of a limited number of product candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never become profitable.
  ●
  The marketing approval process of the U.S. Food and Drug Association, or FDA, is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future product candidates we intend to develop, our business will be substantially harmed.
  ●
  The future results of our current or future clinical trials may not support our product candidates' claims or may result in the discovery of unexpected adverse side effects.
  ●
  Even if we obtain regulatory approval of our vaccine candidates, the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in the medical community.
  ●
  We may be adversely affected by the ongoing coronavirus pandemic.
  ●
  We intend to rely on third parties to conduct our clinical trials and to conduct some aspects of our research and pre-clinical testing and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
  ●
  Our Chief Executive Officer, Chief Financial Officer and other key personnel may allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs and potentially competitive fiduciary and pecuniary interests that conflict with our interests.
  ●
  We may in the future have conflicts with our current or future partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.
  ●
  It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could compete against us more directly, which would harm our business, possibly materially.
  ●
  We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
  ●
  Some of the intellectual property covered by our licenses concerns patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.
  ●
  If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.
  61
  ●
  Healthcare Reform in the United States has been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry. Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.
  ●
  Obtaining regulatory approval for clinical trials of our vaccine candidates in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory approval for the pediatric populations are more stringent.
  ●
  The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.
  ●
  Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock.
  ●
  We are an "emerging growth company" and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.
  ●
  Our amended and restated certificate of incorporation ("Amended and Restated Certificate of Incorporation") and our amended and restated bylaws ("Amended and Restated Bylaws"), and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.
  ●
  A possible "short squeeze" due to a sudden increase in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.
  Other
  We were incorporated on October
  22, 2018 under the laws of the State of Delaware. Our principal executive offices are located at 201 E Fifth Street, Suite 1900, Cincinnati,
  OH 45202, and our telephone number is (513) 620-4101. Our corporate website address is
  www.bluewatervaccines.com
  . We make
  available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
  on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of
  the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities
  and Exchange Commission (the "SEC"). Alternatively, you may also access our reports at the SEC's website at www.sec.gov.
  62
  RISK FACTORS
  Our business involves a high
  degree of risk and uncertainty, including the following risks and uncertainties:
  Investing in our common stock involves a high
  degree of risk. You should carefully consider the following information about these risks before deciding to invest in our common stock.
  The occurrence of any of the following risks could have a material adverse effect on our business, reputation, financial condition, results
  of operations and future growth prospects, as well as our ability to accomplish our strategic objectives. As a result, the trading
  price of our common stock could decline and you could lose all or part of your investment. Additional risks and uncertainties not presently
  known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.
  Risks Related to our Financial Position and Need for Capital
  We are in the early stages of vaccine development and have a
  very limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success
  of our business to date and to assess our future viability.
  To date, we have devoted substantially all of
  our resources to performing research and development, undertaking preclinical studies and enabling manufacturing activities in support
  of our product development efforts, hiring personnel, licensing and developing our technology and vaccine candidates, organizing and staffing
  our company, performing business planning, establishing our intellectual property portfolio and raising capital to support and expand
  such activities. As an organization, we have not yet demonstrated an ability to successfully complete clinical development, obtain regulatory
  approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization
  or arrange for a third party to conduct these activities on our behalf. Consequently, any predictions about our future success or viability
  may not be as accurate as they could be if we had a longer operating history.
  Our current vaccine candidate pipeline includes
  four preclinical programs. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors
  in achieving our business objectives, including with respect to our vaccine candidates. We will need to transition in the future from
  a company with a research and development focus to a company capable of supporting commercial activities and may not be successful in
  such a transition.
  We have incurred significant net losses since inception, do not
  generate any revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve
  profitability. Our stock is a highly speculative investment.
  We are a preclinical stage biotechnology vaccine
  company that was incorporated in October 2018. Investment in preclinical stage companies and vaccine development is highly speculative
  because it entails substantial upfront capital expenditures and significant risk that any potential vaccine candidate will not gain regulatory
  approval or become commercially viable. We do not have any products approved for sale and have not generated any revenue from product
  sales. As a result, we are not profitable and have incurred losses in each year since inception. Our net loss was $2.1 million for the
  three months ended March 31, 2022. As of March 31, 2022, we had an accumulated deficit of $8.0 million. We also generated negative operating
  cash flows of $0.9 million for the three months ended March 31, 2022. Our net losses were $3.4 million and $1.6 million for the years
  ended December 31, 2021 and 2020, respectively. As of December 31, 2021, we had an accumulated deficit of $6.0 million.
  We expect to continue to spend significant resources
  to fund research and development of, and seek regulatory approvals for, our vaccine candidates. We expect to incur substantial and increasing
  operating losses over the next several years as our research, development, manufacturing, preclinical testing and clinical trial
  activities increase. As a result, our accumulated deficit will also increase significantly. Additionally, there can be no assurance that
  the product candidates currently under development or that may be under development by us in the future will be approved for sale in the
  U.S. or elsewhere. Furthermore, there can be no assurance that if such products are approved they will be successfully commercialized,
  and the extent of our future losses and the timing of our profitability are highly uncertain. If we are unable to achieve profitability,
  we may be unable to continue our operations.
  63
  We will require substantial additional funding to finance our
  long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain
  of our development programs or other operations.
  As of March 31, 2022, we had cash of $18.6 million,
  and as of April 30, 2022, we had cash of $24.2 million. As of December 31, 2021, we had cash of $1.9 million. On April 19, 2022 we closed
  a Private Placement from which we received aggregate gross proceeds of approximately $8.0 million, before deducting placement agent fees
  and other Offering expenses. We estimate that, based on our existing cash as of the date of this registration statement, we have cash
  on hand sufficient to fund our operations for at least the next 12 months. We will need to raise additional capital prior to commencing
  additional pivotal trials for certain of our vaccine candidates. We believe that we will need to raise substantial additional capital
  to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates
  in the long-term. Our business or operating plan may change as a result of many factors currently unknown to us, and we may need to seek
  additional funds sooner than planned. We expect to finance our subsequent cash needs through public or private equity or debt financings,
  third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances
  and licensing arrangements or any combination of these approaches. In addition, we may need to accelerate the growth of our sales capabilities
  and distribution beyond what is currently envisioned, and this would require additional capital.
  However, we may not be able to secure funding
  when we need it or on favorable terms and we may not be able to raise sufficient funds to commercialize our current and future product
  candidates we intend to develop. Our ability to raise additional capital may be adversely impacted by potential worsening global economic
  conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide, including
  the trading price of common stock, resulting from the ongoing COVID-19 pandemic. Our future capital requirements will depend on many factors,
  including:
  ●
  the timing, scope, progress, results and costs of research and development, testing, screening, manufacturing, preclinical development and clinical trials;
  ●
  the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform field efficacy studies for our vaccine candidates, require more studies than those that we currently expect or change their requirements regarding the data required to support a marketing application;
  ●
  the cost of building a sales force in anticipation of any product commercialization;
  ●
  the costs of future commercialization activities, including product manufacturing, marketing, sales, royalties and distribution, for any of our vaccine candidates for which we receive marketing approval;
  ●
  our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
  ●
  any product liability or other lawsuits related to our products;
  ●
  the expenses needed to attract, hire and retain skilled personnel;
  ●
  the revenue, if any, received from commercial sales, or sales to foreign governments, of our vaccine candidates for which we may receive marketing approval;
  ●
  the costs to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing of any patents or other intellectual property rights;
  64
  ●
  the expenses needed to attract, hire and retain skilled personnel;
  ●
  the costs of operating as a public company; and
  ●
  the impact of the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.
  Our ability to raise additional funds will depend
  on financial, economic and other factors, many of which are beyond our control. We cannot be certain that additional funding will be available
  on acceptable terms, or at all. We have no committed source of additional capital and if we are unable to raise additional capital in
  sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization
  of our vaccine candidates or other research and development initiatives. Our license agreements may also be terminated if we are unable
  to meet the payment obligations or milestones under the agreements. We could be required to seek collaborators for our vaccine candidates
  at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available, or relinquish
  or license on unfavorable terms our rights to our vaccine candidates in markets where we otherwise would seek to pursue development or
  commercialization ourselves.
  We may consider strategic alternatives in order to maximize stockholder
  value, including financings, strategic alliances, licensing arrangements, acquisitions or the possible sale of our business. We may not
  be able to identify or consummate any suitable strategic alternatives and any consummated strategic alternatives may have an adverse impact
  on our vaccine candidates.
  We may consider all strategic alternatives that
  may be available to us to maximize stockholder value, including financings, strategic alliances, licensing arrangements, acquisitions
  or the possible sale of our business.Our exploration of various strategic alternatives may not result in any specific action or transaction.
  To the extent that this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction.
  There can be no assurance that we will enter into any transaction as a result of the engagement. Furthermore, if we determine to engage
  in a strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price.
  We also cannot predict the impact on our stock price if we fail to enter into a transaction.
  In addition, we face significant competition in
  seeking appropriate strategic partners, and the negotiation process is time-consuming and complex. Moreover, we may not be successful
  in our efforts to establish a strategic partnership or other alternative arrangements for our vaccine candidates because they may be deemed
  to be at too early of a stage of development for collaborative effort, and third parties may not view our vaccine candidates as having
  the requisite potential to demonstrate safety and efficacy. Any delays in entering into new strategic partnership agreements related to
  our vaccine candidates could delay the development and commercialization of our vaccine candidates in certain geographies for certain
  indications, which would harm our business prospects, financial condition and results of operations.
  If we license products or businesses, we may not
  be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company
  culture. We cannot be certain that, following a strategic transaction or license, we will achieve the results, revenue or specific net
  income that justifies such transaction.
  Raising additional capital may cause dilution to our existing
  stockholders and investors, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms
  to us.
  We may seek additional capital through a variety
  of means, including through private and public equity offerings and debt financings, collaborations, strategic alliances and marketing,
  distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt
  securities, or through the issuance of shares under other types of contracts, or upon the exercise or conversion of outstanding options,
  warrants, convertible debt or other similar securities, the ownership interests of our stockholders will be diluted, and the terms of
  such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and
  other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior to
  those of our holders of common stock in terms of the payment of dividends or in the event of a liquidation. In addition, debt financing,
  if available, could include covenants limiting or restricting our ability to take certain actions, such as incurring additional debt,
  making capital expenditures, entering into licensing arrangements, or declaring dividends and may require us to grant security interests
  in our assets. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution or licensing arrangements
  with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidates
  or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
  when needed, we may need to curtail or cease our operations.
  65
  Due to the significant resources required for the development
  of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates.
  Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine
  candidates that may be more profitable or for which there is a greater likelihood of success.
  Due to the significant resources required for
  the development of our vaccine candidates, we must decide which vaccine candidates to pursue and advance and the amount of resources to
  allocate to each. Our decisions concerning the allocation of research, development, management and financial resources toward particular
  vaccine candidates may not lead to the development of any viable commercial vaccines and may divert resources away from better opportunities.
  Similarly, our potential decisions to delay, terminate, license or collaborate with third parties in respect of certain vaccine candidates
  may subsequently also prove to be less than optimal and could cause us to miss valuable opportunities. If we make incorrect determinations
  regarding the viability or market potential of any of our vaccine candidates or misread trends in the biopharmaceutical industry, in particular
  for vaccines, our business could be seriously harmed. As a result, we may fail to capitalize on viable commercial products or profitable
  market opportunities, be required to forego or delay pursuit of opportunities with other vaccine candidates that may later prove to have
  greater commercial potential than those we choose to pursue or relinquish valuable rights to such vaccine candidates through collaboration,
  licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain
  sole development and commercialization rights.
  We have identified weaknesses in our internal controls, and we
  cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in
  the future.
  As a public company, we are subject to the reporting
  requirements of the Exchange Act, and the Sarbanes-Oxley Act. We expect that the requirements of these rules and regulations will continue
  to increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and
  place significant strain on our personnel, systems and resources.
  The Sarbanes-Oxley Act requires, among other things,
  that we maintain effective disclosure controls and procedures, and internal control over financial reporting.
  We do not yet have effective disclosure controls
  and procedures, or internal controls over all aspects of our financial reporting. We are continuing to develop and refine our disclosure
  controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we will
  file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. Our management
  has deemed certain conditions to be material weaknesses in our internal controls. For example, we failed to employ a sufficient number
  of staff to maintain optimal segregation of duties and to provide optimal levels of oversight in order to process financial information
  in a timely manner, analyze and account for complex, non-routine transactions, and prepare financial statements. In addition, we do not
  yet have adequate internal controls in place for the timely identification, approval or reporting of related party transactions. Our management
  is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under
  the Exchange Act. We will be required to expend time and resources to further improve our internal controls over financial reporting,
  including by expanding our staff to include financial consultants and other qualified resources, which we commenced during the fourth
  quarter of 2021. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify
  or avoid material weaknesses in the future.
  Our current controls and any new controls that
  we develop may become inadequate because of changes in conditions in our business, including increased complexity resulting from our international
  expansion. Further, weaknesses in our disclosure controls or our internal control over financial reporting may be discovered in the future.
  Any failure to develop or maintain effective controls, or any difficulties encountered in their implementation or improvement, could harm
  our operating results or cause us to fail to meet our reporting obligations and may result in a restatement of our financial statements
  for prior periods. Any failure to implement and maintain effective internal control over financial reporting could also adversely affect
  the results of management reports and independent registered public accounting firm audits of our internal control over financial reporting
  that we will eventually be required to include in our periodic reports that will be filed with the SEC. Ineffective disclosure controls
  and procedures, and internal control over financial reporting could also cause investors to lose confidence in our reported financial
  and other information, which would likely have a negative effect on the market price of our common stock.
  66
  We are not currently required to comply with the
  SEC rules that implement Section 404 of the Sarbanes-Oxley Act and are therefore not required to make a formal assessment of the
  effectiveness of our internal control over financial reporting for that purpose. We will be required to provide an annual management report
  on the effectiveness of our internal control over financial reporting commencing with our second annual report on Form 10-K. Our
  independent registered public accounting firm is not required to audit the effectiveness of our internal control over financial reporting
  until after we are no longer an "emerging growth company" as defined in the JOBS Act. At such time, our independent registered
  public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our internal control
  over financial reporting is documented, designed or operating.
  Our ability to use our net operating loss carryforwards and certain
  other tax attributes may be limited, each of which could harm our business.
  As of December 31, 2021, we had U.S. federal
  and state net operating loss carryforwards of approximately $4.9 million and $5.1 million, respectively. Under Sections 382
  and 383 of the Internal Revenue Code, or the Code, if a corporation undergoes an "ownership change," the corporation's
  ability to use its pre-ownership change net operating loss carryforwards and other pre-ownership change tax attributes, such as research
  tax credits, to offset its post-ownership change income and taxes may be limited. In general, an ownership change will occur when the
  percentage of the Corporation's ownership (by value) of one or more "5-percent stockholders" (as defined in the Code)
  has increased by more than 50 percent over the lowest percentage owned by such stockholders at any time during the prior three years
  (calculated on a rolling basis). Similar rules may apply under state tax laws. An entity that experiences an ownership change generally
  will be subject to an annual limitation on its pre-ownership change tax loss and credit carryforwards equal to the equity value of the
  corporation immediately before the ownership change, multiplied by the long-term, tax-exempt rate posted monthly by the U.S. Internal
  Revenue Service (subject to certain adjustments). The annual limitation would be increased each year to the extent that there is an unused
  limitation in a prior year. In the event that it is determined that we have in the past experienced an ownership change as a result of
  transactions in our stock, or if we experience one or more ownership changes as a result of future transactions in our stock, then we
  may be limited in our ability to use our net operating loss carryforwards and other tax assets to reduce taxes owed on the net taxable
  income that we earn. Any limitations on the ability to use our net operating loss carryforwards and other tax assets could harm our business.
  Our insurance coverage may be inadequate or expensive.
  We are subject to claims in the ordinary course
  of business. These claims may involve substantial amounts of money and involve significant defense costs. It is not possible to prevent
  or detect all activities giving rise to claims and the precautions we take may not be effective in all cases. We maintain voluntary and
  required insurance coverage, including, among others, general liability, property, director and officer, business interruption, cyber
  and data breach. Our insurance coverage is expensive and maintaining or expanding our insurance coverage may have an adverse effect on
  our results of operations and financial condition.
  Our insurance coverage may be insufficient to
  protect us against all losses and costs stemming from operational and technological failures and we cannot be certain that such insurance
  will continue to be available to us on economically reasonable terms, or at all, or that any insurer will not deny coverage as to any
  future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, or the occurrence
  of changes in our insurance policies, including premium increases or the imposition of large retention, or deductible, or co-insurance
  requirements, could have an adverse effect on our business, financial condition and results of operations.
  67
  Risks Related to the Development of our Product Candidates
  We depend entirely on the success of a limited number of product
  candidates, which are in preclinical development and none of which have commenced a clinical trial. If we do not obtain regulatory approval
  for and successfully commercialize one or more of our product candidates or we experience significant delays in doing so, we may never
  become profitable.
  We do not have any products that have received
  regulatory approval and may never be able to develop marketable product candidates. We expect that a substantial portion of our efforts
  and expenses over the next few years will be devoted to the development of our product candidates; specifically, the commencement
  of Phase I clinical trials for our vaccine candidates. As a result, our business currently depends heavily on the successful development,
  regulatory approval and, if approved, commercialization of these product candidates. We cannot be certain that our product candidates
  will receive regulatory approval or will be successfully commercialized even if they receive regulatory approval. The research, testing,
  manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain,
  subject to comprehensive regulation by the FDA and similar foreign regulatory authorities. Before obtaining regulatory approvals for the
  commercial sale of any product candidate, we must demonstrate through pre-clinical studies and clinical trials that the product candidate
  is safe and effective for use in each target indication. Vaccine development is a long, expensive and uncertain process, and delay or
  failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates in the
  United States will prevent us from commercializing and marketing our product candidates. The success of our product candidates will
  depend on several additional factors, including:
  ●
  completing clinical trials that demonstrate their efficacy and safety;
  ●
  receiving marketing approvals from applicable regulatory authorities;
  ●
  completing any post-marketing studies required by applicable regulatory authorities;
  ●
  establishing commercial manufacturing capabilities;
  ●
  launching commercial sales, marketing and distribution operations;
  ●
  the prevalence and severity of adverse events experienced with our product candidates;
  ●
  acceptance of our product candidates by patients, the medical community and third-party payors;
  ●
  a continued acceptable safety profile following approval;
  ●
  obtaining and maintaining healthcare coverage and adequate reimbursement for our product candidates;
  ●
  competing effectively with other therapies, including with respect to the sales and marketing of our product candidates, if approved; and
  ●
  qualifying for, maintaining, enforcing and defending our intellectual property rights and claims.
  Many of these factors are beyond our control,
  including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual
  property rights and changes in the competitive landscape. It is possible that none of our product candidates will ever obtain regulatory
  approval, even if we expend substantial time and resources seeking such approval. If we do not achieve one or more of these factors in
  a timely manner or at all, we could experience significant delays or an inability to successfully complete clinical trials, obtain regulatory
  approval or, if approved, commercialize our product candidates, which would materially harm our business, financial condition and results
  of operations.
  68
  The marketing approval process of the FDA is lengthy, time consuming
  and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our current product candidates and future
  product candidates we intend to develop, our business will be substantially harmed.
  We are at a very early stage of development for
  all of our product candidates. The product candidates we intend to develop have not gained marketing approval in the U.S., and we cannot
  guarantee that we will ever have marketable products. Our business is substantially dependent on our ability to complete the development
  of, obtain marketing approval for, and successfully commercialize our current and future product candidates in a timely manner. We cannot
  commercialize our product candidates in the United States without first obtaining approval from the FDA to market each product candidate.
  Our product candidates could fail to receive marketing approval for many reasons, including among others:
  ●
  the FDA may disagree with the design or implementation of our clinical trials;
  ●
  Our clinical trials for our product candidate(s) must be successful if we are to seek and obtain regulatory marketing application through the submission of a new Biological License Application (BLA) and marketing authorization application (MAA) with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. Advanced clinical trials are often not successful even if prior trials were successful, and even if we are able to conduct advanced clinical trials and those trials are successful, we may not obtain necessary regulatory approvals for our product candidate(s) or we may be unable to successfully commercialize our products even if we receive the necessary regulatory approvals
  In addition, the process of seeking regulatory
  approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding the effort and expense
  incurred, approval is never guaranteed. If we are not successful in obtaining timely approval of our product candidates from the FDA,
  we may never be able to generate significant revenue and may be forced to cease operations. The new Biological License Application, or
  BLA, process is costly, lengthy and uncertain. Any BLA application filed by us will have to be supported by extensive data, including,
  but not limited to, technical, pre-clinical, clinical, manufacturing and labelling data, to demonstrate to the FDA's satisfaction
  the safety and efficacy of the product for its intended use.
  In order to commence a clinical trial in the United States,
  we will be required to seek FDA acceptance of an IND for each of our product candidates. We cannot be sure any IND we submit to the FDA,
  or any similar clinical trial application we submit in other countries, will be accepted. If we will be required by regulatory authorities
  to conduct additional preclinical testing prior to filing an IND or similar application to clinically evaluate any of our product candidates,
  this may result in delay in our product candidate development. The results of any such preclinical testing may not be positive and may
  not support an application to study any of our product candidates in additional clinical trials.
  It is possible that the FDA or EMA will not view
  our ongoing or planned trials as providing adequate support for future clinical trials or for an application for marketing approval, for
  any one or more reasons, including elements of the design or execution of the trials or safety concerns or other trial results. If we
  are unable to confirm or replicate the results of our trials in larger patient group or if negative results are obtained, we would likely
  be further delayed or prevented from advancing further clinical development any of our product candidates.
  Additionally, the FDA or EMA may disagree with
  the sufficiency of our proposed reliance upon the preclinical, manufacturing or clinical data generated by third-party academic-sponsored
  trials, or our interpretation of preclinical, manufacturing or clinical data from our ongoing trials. If so, the FDA or EMA may require
  us to obtain and submit additional preclinical, manufacturing or clinical data.
  Obtaining approvals from the FDA and from the
  regulatory agencies in other countries is an expensive and time-consuming process and is uncertain as to outcome. The FDA and other agencies
  could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming
  actions, or it could simply deny our applications. In addition, even if we obtain a BLA approval or pre-market approvals in other countries,
  the approval could be revoked or other restrictions imposed if post-market data demonstrate safety issues or lack of effectiveness. We
  cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals, our financial
  condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may be limited. Additionally,
  even if cleared or approved, our products may not be approved for the specific indications that are most necessary or desirable for successful
  commercialization or profitability.
  69
  We may encounter substantial delays in completing our clinical
  studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of
  applicable regulatory authorities.
  It is impossible to predict if or when our current
  or future product candidates, will prove safe or effective in humans or will receive regulatory approval. Before obtaining marketing
  approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate
  the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome.
  We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of
  one or more clinical studies can occur at any stage of testing. Events that may prevent successful or timely completion of clinical development
  include:
  ●
  delays in reaching, or failing to reach, a consensus with regulatory agencies on study design;
  ●
  delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations, or CROs, and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
  ●
  delays in recruiting a sufficient number of suitable patients to participate in our clinical studies;
  ●
  imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;
  ●
  failure by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;
  ●
  failure to perform in accordance with the FDA's good clinical practices, or GCPs, or applicable regulatory guidelines in other countries;
  ●
  delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;
  ●
  delays in having patients complete participation in a study or return for post-treatment follow-up;
  ●
  clinical study sites or patients dropping out of a study;
  ●
  delay or failure to address any patient safety concerns that arise during the course of a trial;
  ●
  unanticipated costs or increases in costs of clinical trials of our product candidates;
  ●
  occurrence of serious adverse events associated with the product candidates that are viewed to outweigh its potential benefits; or
  ●
  changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.
  We could also encounter delays if a clinical trial
  is suspended or terminated by us, by the Institutional Review Board, or IRB, or the Ethics Commission of the institutions in which such
  trials are being conducted, by an independent Safety Review Board, or SRB, for such trial or by the FDA or other regulatory authorities.
  Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical
  trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site
  by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects,
  failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate
  funding to continue the clinical trial.
  Any inability to successfully complete pre-clinical
  and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory
  and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes to our product candidates,
  we may need to conduct additional studies to bridge our modified product candidates to earlier versions.
  Clinical study delays could also shorten any periods
  during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market
  before we do, which could impair our ability to successfully commercialize our product candidates. In addition, any delays in completing
  our clinical trials will increase our costs, slow down our product candidates' development and approval process and jeopardize
  our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business, financial condition
  and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may
  also ultimately lead to the denial of regulatory approval of our product candidates.
  70
  The outcome of pre-clinical studies and early
  clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily
  predict final results. Further, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and many
  companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials have nonetheless
  failed to obtain marketing approval. If the results of our clinical studies are inconclusive or if there are safety concerns or adverse
  events associated with our product candidates, we may:
  ●
  be delayed in obtaining marketing approval for our product candidates, if approved at all;
  ●
  obtain approval for indications or patient populations that are not as broad as intended or desired;
  ●
  obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;
  ●
  be required to change the way the product is administered;
  ●
  be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;
  ●
  have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;
  ●
  be sued; or
  ●
  experience damage to our reputation.
  Additionally, our product candidates could potentially
  cause other adverse events that have not yet been predicted. The inclusion of ill patients in our clinical studies may result in deaths
  or other adverse medical events due to other therapies or medications that such patients may be using. As described above, any of these
  events could prevent us from achieving or maintaining market acceptance of our product candidates and impair our ability to commercialize
  our products.
  Obtaining and maintaining regulatory approval of our vaccine
  candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our vaccine candidates in
  other jurisdictions.
  Obtaining and maintaining regulatory approval
  of our vaccine candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any
  other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory
  approval process in others. For example, even if the FDA grants marketing approval of a vaccine candidate, comparable regulatory authorities
  in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the vaccine candidate in those countries. Approval
  procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those
  in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction
  may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a vaccine
  candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we
  intend to charge for our products is also subject to approval.
  We may also submit marketing applications in other
  countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of vaccine candidates
  with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign
  regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction
  of our products in certain countries. If we fail to comply with the regulatory requirements in international markets and/or receive applicable
  marketing approvals, our target market will be reduced and our ability to realize the full market potential of our vaccine candidates
  will be harmed.
  Modifications to our products may require new BLA approvals.
  Once a particular product receives FDA approval,
  expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory approvals, including
  additional IND and BLA submissions and premarket approvals before we can begin clinical development, and/or prior to marketing and sales.
  If the FDA requires new approvals for a particular use or indication, we may be required to conduct additional clinical studies, which
  would require additional expenditures and harm our operating results. If the products are already being used for these new indications,
  we may also be subject to significant enforcement actions. Conducting clinical trials and obtaining approvals can be a time-consuming
  process, and delays in obtaining required future approvals could adversely affect our ability to introduce new or enhanced products in
  a timely manner, which in turn would harm our future growth.
  71
  Additional delays to the completion of clinical studies may result
  from modifications being made to the protocol during the clinical trial, if such modifications are warranted and/or required by the occurrences
  in the given trial
  .
  Each modification to the protocol during a clinical
  trial has to be submitted to the FDA. This could result in the delay or halt of a clinical trial while the modification is evaluated.
  In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data generated by the
  clinical trial are not poolable because the same protocol was not used throughout the trial. This might require the enrollment of additional
  subjects, which could result in the extension of the clinical trial and the FDA delaying approval of a product. Any such delay could have
  a material adverse effect on our business and results of operations.
  There can be no assurance that the data generated from our clinical
  trials using modified protocols will be acceptable to the FDA or other regulatory authorities.
  There can be no assurance that the data generated
  using modified protocols will be acceptable to the FDA or other regulatory authorities or that if future modifications during the trial
  are necessary, that any such modifications will be acceptable to the FDA or other regulatory authorities. If the FDA or other regulatory
  authorities believe that prior approval is required for a particular modification, they can delay or halt a clinical trial while they
  evaluate additional information regarding the change.
  Serious injury or death resulting from a failure
  of our product candidates during current or future clinical trials could also result in the FDA or other regulatory authority delaying
  our clinical trials or denying or delaying approval of a product.
  Even though an adverse event may not be the result
  of the failure of our product candidate, the FDA or other regulatory authority could delay or halt a clinical trial for an indefinite
  period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.
  Any delay or termination of our current or future
  clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals from the FDA
  or other regulatory authorities, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial,
  and delays or termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase
  in costs and delays in the filing of any product submissions with the FDA or other regulatory authorities, delay the approval and commercialization
  of our products or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.
  We will depend on enrollment and retention of patients in our
  clinical trials for our product candidates. If we experience delays or difficulties enrolling or retaining patients in our clinical trials,
  our research and development efforts and business, financial condition, and results of operations could be materially adversely affected.
  Successful and timely completion of clinical trials
  will require that we enroll and retain a sufficient number of patient candidates. Any clinical trials we conduct may be subject to delays
  for a variety of reasons, including as a result of patient enrollment taking longer than anticipated, patient withdrawal, or adverse events.
  These types of developments could cause us to delay the trial or halt further development.
  Our clinical trials will compete with other clinical
  trials that are in the same therapeutic areas as our product candidates, and this competition reduces the number and types of patients
  available to us, as some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by
  one of our competitors. Moreover, enrolling patients in clinical trials for diseases in which there is an approved standard of care is
  challenging, as patients will first receive the applicable standard of care. Many patients who respond positively to the standard of care
  do not enroll in clinical trials. This may limit the number of eligible patients able to enroll in our clinical trials who have the potential
  to benefit from our product candidates and could extend development timelines or increase costs for these programs. Patients who fail
  to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates. However, these
  prior treatment regimens may render our therapies less effective in clinical trials.
  Because the number of qualified clinical investigators
  and clinical trial sites is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our
  competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.
  72
  Patient enrollment depends on many factors, including:
  ●
  the size and nature of the patient population;
  ●
  the severity of the disease, condition or infection under investigation;
  ●
  eligibility criteria for the trial;
  ●
  the proximity of patients to clinical sites;
  ●
  the design of the clinical protocol;
  ●
  the ability to obtain and maintain patient consents;
  ●
  perceived risks and benefits of the product candidate under evaluation;
  ●
  the ability to recruit clinical trial investigators with the appropriate competencies and experience;
  ●
  the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion;
  ●
  the availability of competing clinical trials;
  ●
  the availability of such patients during the COVID-19 pandemic;
  ●
  the availability of new drugs approved for the indication the clinical trial is investigating; and
  ●
  clinicians' and patients' perceptions as to the potential advantages of the drug being studied in relation to other available therapies.
  These factors may make it difficult for us to
  enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical
  trial of our product candidates will increase our costs, slow down our product candidate development and approval process, and delay or
  potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause, or lead
  to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our
  product candidates.
  Conducting successful clinical studies may require the enrollment
  of large numbers of patients, and suitable patients may be difficult to identify and recruit.
  Patient enrollment in clinical trials and completion
  of patient participation and follow-up depends on many factors, including the size of the patient population; the nature of the trial
  protocol; the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; the availability
  of appropriate clinical trial investigators; support staff; and the proximity of patients to clinical sites and ability to comply with
  the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged
  from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up
  to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are
  not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to
  participate in contemporaneous clinical trials of competitive products.
  The results of our future clinical trials may not support our
  product candidates' claims or may result in the discovery of unexpected adverse side effects.
  Even if our clinical trials are completed as planned,
  we cannot be certain that their results will support our product candidates claims or that the FDA or foreign authorities will agree with
  our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will
  be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical
  trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses. If the FDA concludes
  that the clinical trials for any product for which we might seek approval, has failed to demonstrate safety and effectiveness, we would
  not receive FDA approval to market that product in the United States for the indications sought.
  In addition, such an outcome could cause us to
  abandon a product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing
  of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues. It
  is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of our product
  candidates' profiles.
  73
  Adverse events involving our products may lead the FDA or other
  regulatory authorities to delay or deny approval for our products or result in product recalls that could harm our reputation, business
  and financial results.
  Additionally, if any of our product candidates
  receives marketing approval, the FDA could require us to adopt a Risk Evaluation and Mitigation Strategy, or REMS, and other non-U.S. regulatory
  authorities could impose other specific obligations as a condition of approval to ensure that the benefits outweigh its risks, which may
  include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan
  to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if we or
  others later identify undesirable side effects caused by any of our product candidates, several potentially significant negative consequences
  could result, including:
  ●
  regulatory authorities may suspend or withdraw approvals of such a product candidate;
  ●
  regulatory authorities may require additional warnings or limitations of use in product labeling;
  ●
  we may be required to change the way a product candidate is distributed, dispensed, or administered or conduct additional clinical trials;
  ●
  we could be sued and held liable for harm caused to patients; and
  ●
  our reputation may suffer.
  Any of these events could prevent us from achieving
  or maintaining market acceptance of our product candidates and could significantly harm our business, prospects, financial condition and
  results of operations.
  Once a product receives FDA approval, the agency
  has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies or defects
  in design or manufacture. The authority to require a recall must be based on an FDA finding that there is a reasonable probability that
  the product would cause serious injury or death. Manufacturers may, under their own initiative, recall a product if any material deficiency
  in a product is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of adverse side
  effects, impurities or other product contamination, manufacturing errors, design or labeling defects or other deficiencies and issues.
  Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and
  results of operations. The FDA requires that certain classifications of recalls be reported to FDA within ten working days after
  the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We
  may initiate voluntary recalls involving our products in the future. A future recall announcement could harm our reputation with customers
  and negatively affect our sales. In addition, the FDA and/or other regulatory agencies could take enforcement action for failing to report
  the recalls when they were conducted.
  Even if we obtain regulatory approval of our vaccine candidates,
  the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in
  the medical community.
  Even if any of our vaccine candidates receive
  marketing approval, they may fail to receive recommendations for use by regulators or advisory boards that recommend vaccines, or gain
  market acceptance by physicians, patients, third-party payors and others in the medical community. If such vaccine candidates do not achieve
  an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance
  of any vaccine candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:
  ●
  receiving CDC and ACIP recommendations for use, as well as recommendations of comparable foreign regulatory and advisory bodies;
  ●
  prevalence and severity of the disease targets for which our vaccine candidates are approved;
  ●
  physicians, hospitals, third-party payors and patients considering our vaccine candidates as safe and effective;
  ●
  the potential and perceived advantages of our vaccine candidates over existing vaccines, including with respect to spectrum coverage or immunogenicity;
  74
  ●
  the prevalence and severity of any side effects;
  ●
  product labeling or product insert requirements of the FDA or comparable foreign regulatory and advisory bodies;
  ●
  limitations or warnings contained in the labeling approved by the FDA or comparable foreign regulatory and advisory bodies;
  ●
  the timing of market introduction of our vaccine candidates as well as competitive products;
  ●
  the cost of treatment in relation to alternative treatments;
  ●
  the availability of coverage and adequate reimbursement and pricing by third-party payors, including government authorities;
  ●
  the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors, including government authorities;
  ●
  relative convenience and ease of administration, including as compared to competitive vaccines and alternative treatments; and
  ●
  the effectiveness of our sales and marketing efforts.
  In the United States, the CDC and ACIP develop
  vaccine recommendations for both children and adults, as do similar agencies around the world. To develop its recommendations, ACIP forms
  working groups that gather, analyze and prepare scientific information. The ACIP also considers many of the factors above, as well as
  myriad additional factors such as the value of vaccination for the target population regarding the outcomes, health economic data and
  implementation issues. ACIP recommendations are also made within categories, such as in an age group or a specified risk group. For example,
  the ACIP may determine that a preferred recommendation in a smaller child population may be more economical than recommending vaccinations
  for a larger adult population, which could adversely impact our market opportunity.
  New pediatric vaccines that receive an ACIP preferred
  recommendation are almost universally adopted, and adult vaccines that receive a preferred recommendations are widely adopted. For example,
  in 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults ages 65 years and older against pneumococcal
  disease, which caused Prevnar 13 to become the standard of care along with continued use of Pneumovax 23. ACIP can also modify its preferred
  recommendation. For instance, in June 2019, the ACIP voted to revise the pneumococcal vaccination guidelines and recommend Prevnar
  13 for adults 65 and older based on the shared clinical decision making of the provider and patient, rather than a preferred use recommendation,
  which means the decision to vaccinate should be made at the individual level between health care providers and their patients. Pfizer
  recently noted that this revised recommendation is expected to have a negative effect on Prevnar 13 revenue for future periods.
  If our vaccine candidates are approved but fail
  to receive CDC and ACIP recommendations, or recommendations of other comparable foreign regulatory and advisory bodies, or achieve market
  acceptance among physicians, healthcare providers, patients, third-party payors or others in the medical community, we will not be able
  to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that market acceptance
  over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or
  render our products obsolete.
  Obtaining regulatory approval for clinical trials of our vaccine
  candidates in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory
  approval for the pediatric populations are more stringent.
  Pediatric vaccine candidates' development
  may require additional studies to determine safe dosing and long-term monitoring. These additional studies may require investment of significant
  additional resources beyond those required for regulatory approval of the vaccines in adults. Approval of our vaccine candidates may be
  delayed due to these additional requirements and this may have an adverse effect on the commercial prospects of our vaccine candidates,
  especially our pediatric vaccine candidate, BWV-201, as well as delay our ability to generate product revenue, possibly materially. In
  addition, as a result of COVID-19 (or other potential pandemics), there may be a smaller pool of children from which we can enroll for
  our clinical trials. We cannot guarantee that we will receive regulatory approval to commercialize our product candidates in the pediatric
  populations or the adult population.
  75
  Even if we are able to commercialize our product candidates,
  such products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives,
  which would harm our business.
  The regulations that govern marketing approvals,
  pricing, coverage and reimbursement for new drugs vary widely from country to country. In the United States, new and future legislation
  may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.
  Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins
  after marketing or product-licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject
  to continuing governmental control even after initial marketing approval is granted. As a result, we might obtain marketing approval for
  a vaccine in a particular country but then be subject to price regulations that delay its commercial launch, possibly for lengthy time
  periods, and negatively impact the revenue we are able to generate from the sale of the drug in that country. Adverse pricing limitations
  may hinder our ability to commercialize and generate revenue from our product candidates, even if our product candidates obtain marketing
  approval.
  Our ability to commercialize our current and any
  future product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products
  and related treatments will be available from government health programs, private health insurers, integrated delivery networks and other
  third-party payors. Third-party payors decide which vaccines they will pay for and establish reimbursement levels. A significant trend
  in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to
  control costs by limiting coverage and the amount of payment for particular vaccines. Increasingly, third-party payors are requiring that
  drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage
  and reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement
  may not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate
  for which we obtain marketing approval. If coverage and reimbursement is not available or is available only to limited levels, we may
  not be able to successfully commercialize any product candidate for which we obtain marketing approval.
  There may be significant delays in obtaining coverage
  and adequate reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved
  by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for coverage and reimbursement does
  not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,
  sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may
  not be made permanent. Coverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under
  which it is used may be based on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing
  payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs
  or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold
  at lower prices than in the United States. Commercial third-party payors often rely upon Medicare coverage policies and payment limitations
  in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded
  programs and private payors for any approved products that we develop could have a material adverse effect on our operating results, our
  ability to raise capital needed to commercialize our approved products and our overall financial condition.
  Any product candidate for which we obtain marketing approval
  could be subject to marketing restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with
  regulatory requirements or if we experience unanticipated problems with our products.
  Any product candidate for which we obtain marketing
  approval, along with the manufacturing processes and facilities, post-approval clinical data, labeling, advertising and promotional activities
  for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements
  include submissions of promotional materials and safety and other post-marketing information and reports, registration and listing requirements,
  current Good Manufacturing Practice ("cGMP") requirements for product facilities, quality assurance and corresponding maintenance
  of records and documents and requirements regarding the distribution of samples to physicians and related recordkeeping. Even if marketing
  approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may
  be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the
  safety or efficacy of the medicine. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that they are
  marketed only for the approved indications and in accordance with the provisions of the approved labeling. However, companies may share
  truthful and not misleading information that is otherwise consistent with the product's FDA approved labeling. The FDA imposes stringent
  restrictions on manufacturers' communications regarding off-label use and if we do not comply with these restrictions, we may be
  subject to enforcement actions.
  76
  In addition, later discovery of previously unknown
  problems with our products, manufacturers or manufacturing processes and facilities or failure to comply with regulatory requirements,
  may result in, among other things:
  ●
  restrictions on such products, manufacturers or manufacturing processes or facilities;
  ●
  restrictions on the labeling, marketing, distribution or use of a product;
  ●
  requirements to conduct post-approval clinical trials, other studies or other post-approval commitments;
  ●
  warning or untitled letters;
  ●
  withdrawal or recall of the products from the market;
  ●
  refusal to approve pending applications or supplements to approved applications that we submit;
  ●
  fines, restitution or disgorgement of profits or revenue;
  ●
  suspension or withdrawal of marketing approvals;
  ●
  refusal to permit the import or export of our products;
  ●
  product seizure; and
  ●
  injunctions or the imposition of civil or criminal penalties.
  Failure to obtain regulatory approvals in foreign jurisdictions
  will prevent us from marketing our products internationally.
  We intend to market future products in international
  markets. In order to market our future products in regions such as the European Economic Area, or EEA, Asia Pacific, or APAC, and many
  other foreign jurisdictions, we must obtain separate regulatory approvals.
  For example, in the EEA, medicinal products can
  only be commercialized after obtaining a Marketing Authorization, or MA. Before granting the MA, the European Medicines Agency or
  the competent authorities of the member states of the EEA make an assessment of the risk-benefit balance of the product on the basis of
  scientific criteria concerning its quality, safety and efficacy. In Japan, the Pharmaceuticals and Medical Devices Agency, or the PMDA,
  of the Ministry of Health Labour and Welfare, or MHLW, must approve an application under the Pharmaceutical Affairs Act before a new drug
  product may be marketed in Japan.
  We have had limited interactions with foreign
  regulatory authorities. The approval procedures vary among countries and can involve additional clinical testing, and the time required
  to obtain approval may differ from that required to obtain FDA approval. Moreover, clinical studies conducted in one country may not be
  accepted by regulatory authorities in other countries. Approval by the FDA does not ensure approval by regulatory authorities in other
  countries, and approval by one or more foreign regulatory authorities does not ensure approval by regulatory authorities in other foreign
  countries or by the FDA. However, a failure or delay in obtaining regulatory approval in one country may have a negative effect on
  the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval.
  We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even
  if we file we may not receive necessary approvals to commercialize our products in any market.
  If our products do not receive favorable third-party reimbursement,
  or if new restrictive legislation is adopted, market acceptance of our products may be limited and we may not generate significant revenues.
  Our ability to commercialize our products will
  depend in part on the extent to which appropriate reimbursement levels for the cost of our proposed formulations and products and related
  treatments are obtained by governmental authorities, private health insurers and other organizations, such as Health Maintenance Organizations,
  or HMOs. Reimbursement from third parties depends greatly on our ability to present data which demonstrate positive outcomes and reduced
  utilization of other products or services as well as cost data which show that treatment costs using the new product are equal to or less
  than what is currently covered for other products. If our products do not receive favorable third-party reimbursement and patients are
  unwilling or unable to pay for our products out-of-pocket, it could limit our revenues and harm our business.
  77
  The continuing efforts of government and insurance
  companies, health maintenance organizations and other payers of healthcare costs to contain or reduce costs of health care may affect
  our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative
  partners and the availability of capital. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals
  is subject to government control. In the United States, recent federal and state government initiatives have been directed at lowering
  the total cost of health care. In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, a sweeping
  law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud
  and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry
  and impose additional health policy reforms. Federal and state legislatures will likely continue to focus on health care reform, controlling
  the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems. While we cannot predict whether any such
  legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially harm our business,
  financial condition and results of operations.
  Risks Related to our Business and Industry
  We may be adversely affected by the ongoing coronavirus pandemic.
  The outbreak of the novel coronavirus COVID-19
  ("COVID-19") has evolved into a global pandemic. The coronavirus has spread to many regions of the world. The extent to which
  the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be
  accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus
  or treat its impact, among others.
  As a result of the continuing spread of COVID-19,
  our business operations could be delayed or interrupted. Currently, we operate virtually, i.e., our program activities are and will continue
  to be carried out, on our behalf, by competent contract research organizations (CROs) with expertise in pre-clinical, clinical and/or
  chemistry and manufacturing areas. Due to COVID-19, our planned project timelines may be delayed due to reduced availability of human
  resources or critical supplies needed to carry out such plans. Due to shelter-in-place/stay-at-home orders and other government restrictions,
  our employees conducting research and development or manufacturing activities at external vendor locations across the globe may not be
  able to access their laboratory or manufacturing space which may result in our core activities being significantly limited or curtailed,
  possibly for an extended period of time.
  Moreover, our clinical trials may be affected
  by the COVID-19 pandemic. Site initiation, participant recruitment and enrollment, participant dosing, availability and distribution of
  clinical trial materials, study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies,
  federal, state or local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the COVID-19
  pandemic. If the coronavirus continues to spread, some participants and clinical investigators may not be able to execute clinical trial
  protocols per the expected timelines. The new mutations of the virus may also make it harder for us to predict the exact impact (if any)
  on the progression of COVID-19 on our development programs. For example, quarantines or other travel limitations (whether voluntary or
  required) may impede participant movement, affect sponsor access to study sites, or interrupt healthcare services, and we may be unable
  to conduct our clinical trials. Further, if the spread of the COVID-19 pandemic continues and our operations are adversely impacted, we
  risk a delay, default and/or nonperformance under existing agreements which may increase our costs. These cost increases may not be fully
  recoverable or adequately covered by insurance.
  Infections and deaths related to the pandemic
  may disrupt the United States' healthcare and healthcare regulatory systems. Such disruptions could divert healthcare resources
  away from, or materially delay FDA review or review by other regulatory agencies and/or approval with respect to, our clinical trials.
  It is unknown how long these disruptions could continue, were they to occur. Any elongation or de-prioritization of our clinical
  trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of our product
  candidates.
  The spread of the coronavirus, which has caused
  a broad impact globally, including restrictions on travel and quarantine policies put into place by businesses and governments, may have
  a material economic effect on our business. While the potential economic impact brought by and the duration of the pandemic may be difficult
  to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which
  may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained
  adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of
  our common stock.
  The ultimate impact of the current pandemic, or
  any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts
  on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole. However, these effects
  could have a material impact on our operations, and we will continue to monitor the situation closely.
  78
  Our reliance on third parties heightens the risks faced by our
  business.
  We rely on suppliers, vendors and partners for
  certain key aspects of our business, including support for information technology systems and certain human resource functions. We do
  not control these partners, but we depend on them in ways that may be significant to us. If these parties fail to meet our expectations
  or fulfill their obligations to us, we may fail to receive the expected benefits. In addition, if any of these third parties fails to
  comply with applicable laws and regulations in the course of its performance of services for us, there is a risk that we may be held responsible
  for such violations as well. This risk is particularly serious in emerging markets, where corruption is often prevalent and where many
  of the third parties on which we rely do not have internal compliance resources comparable to our own. Any such failures by third parties,
  in emerging markets or elsewhere, could adversely affect our business, reputation, financial condition or results of operations.
  We rely on, and intend to continue to rely on third parties to
  conduct our pre-clinical testing, research and clinical trials, and those third parties may not perform satisfactorily, including failing
  to meet deadlines for the completion of such trials, research or testing.
  We have been relying on third parties for our
  preclinical studies, and we expect to continue to rely on third parties, such as CROs, contract manufacturers of clinical supplies, clinical
  data management organizations, medical institutions and clinical investigators, to conduct our clinical trials and to conduct some aspects
  of our research and pre-clinical testing. These third parties may terminate their engagements with us at any time. If these third parties
  do not successfully carry out their duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements
  or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates
  and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. Furthermore, these third
  parties may also have relationships with other entities, some of which may be our competitors. If we are required to enter into alternative
  arrangements, it could delay our product development activities.
  Our reliance on third parties for research and
  development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we
  will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan
  and protocols for the trial. Moreover, the FDA and other international regulatory authorities require us to comply with GCP standards
  for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate
  and that the rights, integrity and confidentiality of trial participants are protected. We also are required to register ongoing clinical
  trials and post the results of completed clinical trials on a government-sponsored database, available at
  www.clinicaltrials.gov
  ,
  within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
  Upon commercialization of our products, we may be dependent on
  third parties to market, distribute and sell our products.
  Our ability to receive revenues may be dependent
  upon the sales and marketing efforts of any future co-marketing partners and third-party distributors. At this time, we have not entered
  into an agreement with any commercialization partner and only plan to do so prior to commercialization. If we fail to reach an agreement
  with any commercialization partner, or upon reaching such an agreement that partner fails to sell a large volume of our products, it may
  have a negative impact on our business, financial condition and results of operations.
  We have no experience manufacturing product candidates on a clinical
  or commercial scale and will be dependent on third parties for the manufacture of our product candidates. If we experience problems with
  any of these third parties, they could delay clinical development or marketing approval of our product candidates or our ability to sell
  any approved products.
  We do not have any manufacturing facilities. We
  expect to rely on third-party manufacturers for the manufacture of our product candidates for clinical trials and for commercial supply
  of any product candidate for which we obtain marketing approval.
  79
  We may be unable to establish agreements with
  third-party manufacturers for clinical or commercial supply on terms favorable to us, or at all. Even if we are able to establish agreements
  with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
  ●
  reliance on the third party for regulatory compliance and quality assurance;
  ●
  the possible breach of the manufacturing agreement by the third party, including the inability to supply sufficient quantities or to meet quality standards or timelines; and
  ●
  the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
  Third-party manufacturers may not be able to comply
  with U.S. cGMPs or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party
  manufacturers, to comply with cGMPs or other applicable regulations, even if such failures do not relate specifically to our product candidates
  or approved products, could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties,
  delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and
  criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations.
  Any product that we develop may compete with other
  product candidates and products for access to these manufacturing facilities. There are a limited number of manufacturers that operate
  under cGMPs and that might be capable of manufacturing for us.
  Any performance failure on the part of our manufacturers,
  including a failure that may not relate specifically to our product candidates or approved products, could delay clinical development
  or marketing approval or adversely impact our ability to generate commercial sales. If our contract manufacturers cannot perform as agreed,
  we may be required to replace that manufacturer.
  Our anticipated future dependence upon others
  for the manufacture of our current and future product candidates or products may adversely affect our future profit margins and our ability
  to commercialize any product candidates that receive marketing approval on a timely and competitive basis.
  Furthermore, we expect to rely on third parties
  to release, label, store and distribute drug supplies for our clinical trials. Any performance failure on the part of these third parties,
  including a failure that may not relate specifically to our product candidates, could delay or otherwise adversely impact clinical development
  or marketing approval of our product candidates or commercialization of our drug, producing losses and depriving us of potential revenue.
  Moreover, our manufacturers and suppliers may
  experience difficulties related to their overall businesses and financial stability, which could result in delays or interruptions of
  supply of our product candidates.
  Manufacturing risks may adversely affect our ability to
  manufacture our product and could reduce our gross margin and profitability.
  Our business strategy depends on our ability to
  manufacture our product candidates in sufficient quantities and on a timely basis so as to meet our obligations with respect to our clinical
  trials and upon marketing approval, to meet consumer demand, while adhering to product quality standards, complying with regulatory requirements
  and managing manufacturing costs. We are subject to numerous risks relating to our manufacturing capabilities, including:
  ●
  quality or reliability defects in product components that we source from third-party suppliers, including manufacturing compliance with federal and state regulations;
  ●
  our inability to secure product components in a timely manner, in sufficient quantities or on commercially reasonable terms;
  80
  ●
  our failure to increase production of products to meet demand;
  ●
  our inability to modify production lines to enable us to efficiently produce future products or implement changes in current products in response to regulatory requirements; and
  ●
  Potential damage to or destruction of our manufacturing equipment or manufacturing facility.
  If demand for our product candidates increases
  in the future, we will have to invest additional resources to purchase components, hire and train employees, and enhance our manufacturing processes.
  If we fail to increase our production capacity efficiently, our sales may not increase in line with our forecasts and our operating margins
  could fluctuate or decline. In addition, although we expect some of our product candidates in development to share product features and
  components, manufacturing of some of our product candidates may require the modification of our production lines, the hiring
  of specialized employees, the identification of new suppliers for specific components, or the development of new manufacturing technologies.
  It may not be possible for us to manufacture these product candidates at a cost or in quantities sufficient to make these product candidates
  commercially viable. Any of these factors may affect our ability to manufacture our product and could reduce our gross margin and profitability.
  We maintain single supply relationships for certain key components,
  and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its manufacturing process
  increases.
  We are dependent on sole suppliers or a limited
  number of suppliers for certain components that are integral to its finished products. If these or other suppliers encounter financial,
  operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish or qualify replacement
  sources of supply and could face production interruptions, delays and inefficiencies. In addition, technology changes by our vendors could
  disrupt access to required manufacturing capacity or require expensive, time consuming development efforts to adapt and integrate
  new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipment and materials
  in sufficient quantities to support our growth. Any one of these factors could harm our business and growth prospects.
  We may not be able to manage our manufacturing and
  supply chain effectively, which would harm our results of operations.
  We must accurately forecast our clinical trial
  obligations, and, in the future, market demand, for our product candidates in order to have adequate product inventory available to fulfil
  our timeline and customer orders timely. Our forecasts will be based on multiple assumptions that may cause our estimates to be inaccurate,
  and thus affect our ability to ensure adequate manufacturing capability to satisfy product candidate needs or market demand. Any material
  delay in our ability to obtain timely product inventories from our manufacturing facility and our ingredient suppliers could prevent us
  from satisfying increased consumer demand for our products, resulting in material harm to our clinical trials, brand and business. In
  addition, we will need to continuously monitor our inventory and product mix against forecasted demand to avoid having inadequate product
  inventory or having too much product inventory on hand. If we are unable to manage our supply chain effectively, our operating costs may
  increase materially.
  We may in the future have conflicts with our current or future
  partners or third party providers that could delay or prevent the development or commercialization of our current and future product candidates.
  We may in the future have conflicts with our current
  or future partners or third party providers, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement
  of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership of intellectual
  property developed during our collaboration. If any conflicts arise with any of our partners, such partner may act in a manner that is
  adverse to our best interests. Any such disagreement could result in one or more of the following, each of which could delay or prevent
  the development or commercialization of our current and future product candidates, and in turn prevent us from generating revenues:
  ●
  unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;
  ●
  uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into additional collaborations;
  81
  ●
  unwillingness by the partner to cooperate in the development or manufacture of the product, including providing us with product data or materials;
  ●
  unwillingness on the part of a partner to keep us informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those activities;
  ●
  initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or
  ●
  attempts by either party to terminate the agreement.
  Our product candidates may face competition sooner than anticipated
  from biosimilar products.
  Even if we are successful in achieving regulatory
  approval to commercialize a product candidate faster than our competitors, our product candidates may face competition from biosimilar
  products. In the United States, our product candidates are regulated by the FDA as biologic products and we intend to seek approval
  for these product candidates pursuant to the BLA pathway. The Biologics Price Competition and Innovation Act of 2009, or BPCIA,
  created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway
  establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar
  as "interchangeable" based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar
  product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA. The law is
  complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning
  are subject to uncertainty.
  There is a risk that any exclusivity we may be
  afforded if any of our product candidates are approved as a biologic product under a BLA could be shortened due to congressional action,
  the results of recent litigation, or otherwise, or that the FDA will not consider our product candidates to be reference products for
  competing products, potentially creating the opportunity for generic or biosimilar competition sooner than anticipated. Moreover, the
  extent to which a biosimilar product, once approved, will be substituted for any one of our reference products in a way that is similar
  to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory
  factors that are still developing. In addition, a competitor could decide to forego the biosimilar approval path and submit a full BLA
  after completing its own preclinical studies and clinical trials. In such cases, any exclusivity to which we may be eligible under the
  BPCIA would not prevent the competitor from marketing its product as soon as it is approved.
  In addition, critics of the 12-year exclusivity
  period in the biosimilar pathway law will likely continue to seek to shorten the data exclusivity period and/or to encourage the FDA to
  interpret narrowly the law's provisions regarding which new products receive data exclusivity. In December 2019, the US agreed
  to remove from the United States-Mexico-Canada Agreement a requirement for at least 10 years of data exclusivity for biologic
  products. Also, the FDA is considering whether subsequent changes to a licensed biologic would be protected by the remainder of the reference
  product's original 12-year exclusivity period (a concept known in the generic drug context as "umbrella exclusivity").
  If the FDA were to decide that umbrella exclusivity does not apply to biological reference products or were to make other changes to the
  exclusivity period, this could expose us to biosimilar competition at an earlier time. There also have been, and may continue to be, legislative
  and regulatory efforts to promote competition through policies enabling easier generic and biosimilar approval and commercialization,
  including efforts to lower standards for demonstrating biosimilarity or interchangeability, limit patents that may be litigated and/or
  patent settlements and implement preferential reimbursement policies for biosimilars.
  If competitors are able to obtain marketing approval
  for biosimilars referencing our product candidates, if approved, such products may become subject to competition from such biosimilars,
  with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete
  with us in each indication for which our product candidates may have received approval.
  Our primary competitors have significantly greater resources
  and experience than we do, which may make it difficult for us to successfully develop our vaccine candidates, or may result in others
  discovering, developing or commercializing products before or more successfully than us.
  The vaccine market is intensely competitive and
  is dominated by a small number of multinational, globally established pharmaceutical corporations with significant resources; Pfizer,
  Merck, GlaxoSmithKline and Sanofi together control approximately 75% of the global vaccine market. We may also face competition from many
  different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private
  research institutions. For example, Sanofi and SK Chemicals have partnered to develop a PCV, and Affinivax and Astellas have partnered
  to develop an affinity-bound pneumococcal vaccine.
  82
  Vaccine candidates that we successfully develop
  and commercialize may compete with existing vaccines and new vaccines that may become available in the future. Many of our competitors
  have substantially greater financial, lobbying, technical, human and other resources than we do and may be better equipped to develop,
  manufacture and market technologically superior vaccines, including the potential that our competitors may develop chemical processes
  or utilize novel technologies for developing vaccines that may be superior to those we employ. In addition, many of these competitors
  have significantly greater experience than we have in undertaking preclinical testing and clinical trials of new products and in obtaining
  regulatory approvals, including for many vaccine franchises. Accordingly, our competitors may succeed in obtaining FDA approval or a preferred
  recommendation for their products. For example, Prevnar 13 obtained FDA approval for the prevention of invasive pneumococcal disease,
  or IPD, in infants based on non-inferior IgG antibody responses relative to Prevnar, using the surrogate immune endpoints established
  by the prior Prevnar field efficacy study. Pfizer is currently implementing a similar approach to development of its 20-valent PCV vaccine
  candidate, and may have a more efficient path to regulatory approval given Pfizer's and the FDA's previous experience with
  Prevnar 13.
  Many of our competitors have established distribution
  channels for the commercialization of their vaccine products, whereas we have no such established channels or capabilities. In addition,
  many competitors have greater name recognition, more extensive collaborative relationships or the ability to leverage a broader vaccine
  portfolio. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize vaccines that are safer,
  more effective, more convenient, less expensive or with a more favorable label than any vaccine candidates that we may develop.
  As a result of these factors, our competitors
  may obtain regulatory approval of their products before we are able to, which may limit our ability to develop or commercialize our vaccine
  candidates. Our competitors may also develop vaccines that are safer, more effective, more widely accepted or less expensive than ours,
  and may also be more successful than we are in manufacturing and marketing their products. These advantages could render our vaccine candidates
  obsolete or non-competitive before we can recover the costs of such vaccine candidates' development and commercialization.
  Mergers and acquisitions in the pharmaceutical
  and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and
  early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established
  companies. These third parties compete with us in recruiting and retaining qualified scientific, management and commercial personnel,
  establishing clinical trial sites and subject enrollment for clinical trials, as well as in acquiring technologies complementary to, or
  necessary for, our programs.
  Product liability lawsuits against us could cause us to incur
  substantial liabilities and to limit commercialization of any products that we may develop.
  We face an inherent risk of product liability
  exposure related to the testing of our current product candidates or future product candidates in human clinical trials and will face
  an even greater risk if we commercially sell any products that we may develop. Product liability claims may be brought against us by subjects
  enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our product. If we cannot successfully
  defend ourselves against claims that our product candidates or product caused injuries, we could incur substantial liabilities. Regardless
  of merit or eventual outcome, liability claims may result in:
  ●
  decreased demand for any product candidates or products that we may develop;
  ●
  termination of clinical trial sites or entire clinical trial programs;
  ●
  injury to our reputation and significant negative media attention;
  ●
  withdrawal of clinical trial participants;
  ●
  significant costs to defend the related litigation;
  83
  ●
  substantial monetary awards to trial subjects or patients;
  ●
  loss of revenue;
  ●
  diversion of management and scientific resources from our business operations; and
  ●
  the inability to commercialize any products that we may develop.
  Prior to engaging in future clinical trials, we
  intend to obtain product liability insurance coverage at a level that we believe is customary for similarly situated companies and adequate
  to provide us with insurance coverage for foreseeable risks; however, we may be unable to obtain such coverage at a reasonable cost, if
  at all. If we are able to obtain product liability insurance, we may not be able to maintain insurance coverage at a reasonable cost or
  in an amount adequate to satisfy any liability that may arise and such insurance may not be adequate to cover all liabilities that we
  may incur. Furthermore, we intend to expand our insurance coverage for products to include the sale of commercial products if we obtain
  regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability
  insurance for any products that receive regulatory approval. Large judgments have been awarded in class action lawsuits based on
  drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us, particularly if
  judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.
  We may engage in acquisitions that could disrupt our business,
  cause dilution to our stockholders or reduce our financial resources.
  In the future, we may enter into transactions
  to acquire other businesses, products or technologies. If we do identify suitable candidates, we may not be able to make such acquisitions
  on favorable terms, or at all. Any acquisitions we make may fail to strengthen our competitive position and these transactions may be
  viewed negatively by customers or investors. We may decide to incur debt in connection with an acquisition or issue our common stock or
  other equity securities to the stockholders of the acquired company, which would reduce the percentage ownership of our existing stockholders.
  We could incur losses resulting from undiscovered liabilities of the acquired business that are not covered by the indemnification we
  may obtain from the seller. In addition, we may not be able to successfully integrate the acquired personnel, technologies and operations
  into our existing business in an effective, timely and non-disruptive manner. Acquisitions may also divert management attention from day-to-day
  responsibilities, increase our expenses and reduce our cash available for operations and other uses. We cannot predict the number, timing
  or size of future acquisitions or the effect that any such transactions might have on our operating results.
  Security threats to our information technology infrastructure
  and/or our physical buildings could expose us to liability and damage our reputation and business.
  It is essential to our business strategy that
  our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners
  to be secure. Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security
  threats. We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products
  and services, misappropriate our or our customers' and partners' proprietary information, which may include personally identifiable
  information, or cause interruptions of our internal systems and services. Despite security measures, we also cannot guarantee security
  of our physical buildings. Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network
  infrastructure and our ability to deploy our products and services, harm our relationship with customers and partners that are affected,
  and expose us to financial liability.
  Additionally, there are a number of state, federal
  and international laws protecting the privacy and security of health information and personal data. For example, the Health Insurance
  Portability and Accountability Act of 1996, or HIPAA, imposes limitations on the use and disclosure of an individual's
  healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities,
  and also grants individuals rights with respect to their health information. HIPAA also imposes compliance obligations and corresponding
  penalties for non-compliance on individuals and entities that provide services to healthcare providers and other covered entities.
  As part of the American Recovery and Reinvestment Act of 2009, or ARRA, the privacy and security provisions of HIPAA were amended.
  ARRA also made significant increases in the penalties for improper use or disclosure of an individual's health information under
  HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently by the final omnibus rule adopted
  in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been inappropriately
  accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national
  media. Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured in accordance
  with encryption or other standards developed by the U.S. Department of Health and Human Services. Most states have laws requiring
  notification of affected individuals and/or state regulators in the event of a breach of personal information, which is a broader class
  of information than the health information protected by HIPAA. Many state laws impose significant data security requirements, such
  as encryption or mandatory contractual terms, to ensure ongoing protection of personal information. Activities outside of the U.S. implicate
  local and national data protection standards, impose additional compliance requirements and generate additional risks of enforcement for non-compliance. We may
  be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws,
  to protect against security breaches and hackers or to alleviate problems caused by such breaches.
  84
  We will need to grow the size of our organization in the future,
  and we may experience difficulties in managing this growth.
  As of May 20, 2022, we had 5 full-time and 7 subcontracted
  employees. We will need to grow the size of our organization in order to support our continued development and potential commercialization
  of our product candidates. As our development and commercialization plans and strategies continue to develop, our need for additional
  managerial, operational, manufacturing, sales, marketing, financial and other resources may increase. Our management, personnel and systems
  currently in place may not be adequate to support this future growth. Future growth would impose significant added responsibilities on
  members of management, including:
  ●
  managing our clinical trials effectively;
  ●
  identifying, recruiting, maintaining, motivating and integrating additional employees;
  ●
  managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;
  ●
  improving our managerial, development, operational, information technology, and finance systems; and
  ●
  expanding our facilities.
  If our operations expand, we will also need to
  manage additional relationships with various strategic partners, suppliers and other third parties. Our future financial performance and
  our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future
  growth effectively, as well as our ability to develop a sales and marketing force when appropriate. To that end, we must be able to manage
  our development efforts and pre-clinical studies and clinical trials effectively and hire, train and integrate additional management,
  research and development, manufacturing, administrative and sales and marketing personnel. The failure to accomplish any of these tasks
  could prevent us from successfully growing our company.
  Our future success depends on our ability to retain our executive
  officers and to attract, retain and motivate qualified personnel.
  We are highly dependent upon our personnel, including
  Joseph Hernandez, our Chief Executive Officer and members of our board of directors. The loss of Mr. Hernandez's services could
  impede the achievement of our research, development and commercialization objectives. We have not obtained, do not own, nor are we the
  beneficiary of, key-person life insurance. Our future growth and success depend on our ability to recruit, retain, manage and motivate
  our employees. The loss of any member of our senior management team or the inability to hire or retain experienced management personnel
  could compromise our ability to execute our business plan and harm our operating results. Because of the specialized scientific and managerial
  nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.
  The competition for qualified personnel in the biotechnology field is intense and as a result, we may be unable to continue to attract
  and retain qualified personnel necessary for the development of our business.
  Our Chief Executive Officer, Joseph Hernandez, and our Chief
  Financial Officer, Jon Garfield, also hold certain management positions and directorships of other companies and may allocate their time
  to such other businesses, thereby causing conflicts of interest in their determination as to how much time to devote to our affairs. This
  could have a negative impact on our ability to implement our plan of operation.
  Our Chief Executive Officer, Joseph Hernandez
  is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict of interest
  in allocating his time between our operations and his other businesses. Pursuant to Mr. Hernandez's employment agreement, Mr. Hernandez
  shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business activities.
  Subject to our Board's prior approval, Mr. Hernandez may serve as an officer, stakeholder, or member of the board of directors
  or advisory board (or the equivalent in the case of a non-corporate entity) of non-competing for-profit businesses and charitable organizations,
  provided, however, that such activities do not materially interfere, individually or in the aggregate, with the performance of his duties
  and responsibilities to Blue Water Vaccines Inc. Accordingly, although Mr. Hernandez's primary occupation is his service to
  Blue Water Vaccines Inc., he also holds certain management positions and directorships of other companies, and may allocate his time to
  such other businesses, thereby causing conflicts of interest in his determination as to how much time to devote to our affairs.
  Additionally, our Chief Financial Officer, Jon
  Garfield, is engaged in other business endeavors for which he may be entitled to substantial compensation, which may result in a conflict
  of interest in allocating his time between our operations and his other businesses. Pursuant to Mr. Garfield's employment agreement,
  Mr. Garfield shall be employed with the Company on a full-time basis, but shall be permitted to participate in certain limited business
  activities, subject to the restrictions imposed on Mr. Hernandez as described above. Accordingly, Mr. Garfield holds certain
  management positions and directorships of other companies, and may allocate his time to such other businesses, thereby causing conflicts
  of interest in his determination as to how much time to devote to our affairs
  85
  Each of Messrs. Hernandez and Garfield may also
  have competitive fiduciary obligations and pecuniary interests relating to their other business ventures that conflict with our interests.
  Each of Messrs. Hernandez and Garfield's employment agreement contains certain restrictive covenants while they are employed at
  Blue Water Vaccines Inc. These restrictive covenants, generally, restrict Messrs. Hernandez and Garfield from engaging in any other business
  or occupation that (x) conflicts with the interests of the Company, (y) interferes with the proper and efficient performance
  of his duties for the Company, or (z) interferes with his exercise of judgment in the Company's best interests. Messrs. Hernandez
  and Garfield are further subject to general restrictions regarding the solicitation of employees, certain customers, as well as the use
  or disclosure of any confidential information, of the business of Blue Water Vaccines Inc. Notwithstanding the foregoing, to the extent
  that these additional activities may have a conflict between their interests and ours, this could have a negative impact on our ability
  to implement our plan of operations.
  Certain significant personnel may allocate their time to other
  businesses, which may cause conflicts of interest in their determination as to how much time to devote to our affairs and potentially
  competitive fiduciary and pecuniary interests that conflict with our interests.
  Our executive officers are supported by Ronald
  Cobb, Brian Price and Andrew Skibo, who provide valuable technical and strategic capabilities to us. They are not currently required to
  commit their full time to our affairs. As such, they may allocate their time to other businesses. From time to time, those other commitments
  may limit the nature of services that Messrs. Cobb, Price and Skibo provide to our Company, for instance, where such activities may involve
  overlapping industries and products. If these individuals' other business affairs require them to devote substantial amounts of
  time to such affairs in excess of their current commitment levels, it could limit their ability to devote time or resources to our affairs,
  which may have a negative impact on our ability to complete our plan of operations.
  Members of our management team and board of directors have significant
  experience as founders, board members, officers or executives of other companies. As a result, certain of those persons have been and
  may become involved in proceedings, investigations and litigation relating to the business affairs of the companies with which they were,
  are, or may in the future be, affiliated. This may have an adverse effect on us, could damage our reputation and business.
  During the course of their careers, members of
  our management team and board of directors have had significant experience as founders, board members, officers or executives of other
  companies. As a result of their involvement and positions in these companies, certain persons were, are now, or may in the future become,
  involved in litigation, investigations or other proceedings relating to the business affairs of such companies or transactions entered
  into by such companies. Any such litigation, investigations or other proceedings may divert our management team's and board's
  attention and resources away from our affairs and may negatively affect our reputation and our business.
  Inadequate funding for the FDA, the SEC and other government
  agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being
  developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which
  the operation of our business may rely, which could negatively impact our business.
  The ability of the FDA to review and approve new
  products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel
  and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
  in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may
  rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and
  unpredictable.
  Disruptions at the FDA and other agencies may
  also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect
  our business. For example, over the last several years, including beginning on December 22, 2018, the U.S. government has
  shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other
  government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability
  of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further,
  in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary
  capital in order to properly capitalize and continue our operations.
  86
  We may be adversely affected by natural disasters, pandemics
  and other catastrophic events, some possible related to the increasing effects of climate change, and by man-made problems such as terrorism
  and acts of war, that could disrupt our business operations and our business continuity and disaster recovery plans may not adequately
  protect us from a serious disaster.
  We are vulnerable to the increasing impact of
  climate change and other natural disasters. If a disaster, power outage or other event occurred that prevented us from using all or a
  significant portion of our headquarters, that damaged critical infrastructure, such as enterprise financial systems, manufacturing resource
  planning or enterprise quality systems, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for
  us to continue our business for a substantial period of time. Our contract manufacturers' and suppliers' facilities are located
  in multiple locations, where other natural disasters or similar events, such as blizzards, tornadoes, fires, explosions or large-scale
  accidents or power outages, and other public health emergencies could severely disrupt our operations and have a material adverse effect
  on our business, financial condition, operating results and prospects. For example, the recent COVID-19 pandemic may cause significant
  disruption to our business operations, the operations of our third-party contractors and suppliers and the operations of our clinical
  trials, including as a result of significant restrictions or bans on travel into and within the geographic areas in which our manufacturers
  product our product candidates or where we conduct our clinical trials. A public health emergency could also affect the operations of
  the FDA and other regulatory or public health authorities, resulting in delays to meetings related to planned or completed clinical trials
  and ultimately of reviews and approvals of our product candidates. Such disruption could impede, delay, limit or prevent our employees
  and third-party contractors from beginning or continuing research and development or clinical trial-related activities, which may impede,
  delay, limit or prevent initiation or completion of our ongoing clinical trials and preclinical research and ultimately lead to the delay
  or denial of regulatory approval of our product candidates, which could seriously harm our operations and financial condition.
  Our employees, independent contractors, principal investigators,
  consultants, vendors and clinical research organizations, or CROs, may engage in misconduct or other improper activities, including noncompliance
  with regulatory standards and requirements.
  We are exposed to the risk that our employees,
  independent contractors, principal investigators, consultants, vendors and CROs may engage in fraudulent or other illegal activity. Misconduct
  by these persons could include intentional, reckless or negligent conduct or unauthorized activity that violates: laws or regulations,
  including those laws requiring the reporting of true, complete and accurate information to the FDA or foreign regulatory authorities;
  manufacturing standards; federal, state and foreign healthcare fraud and abuse laws and data privacy; or laws that require the true, complete
  and accurate reporting of financial information or data. In particular, sales, marketing and other business arrangements in the healthcare
  industry are subject to extensive laws intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws may
  restrict or prohibit a wide range of business activities, including research, manufacturing, distribution, pricing, discounting, marketing
  and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve
  the improper use of information obtained in the course of clinical trials, or illegal misappropriation of drug product, which could result
  in regulatory sanctions or other actions or lawsuits stemming from a failure to comply with such laws or regulations, and serious harm
  to our reputation. In addition, federal procurement laws impose substantial penalties for misconduct in connection with government contracts
  and require certain contractors to maintain a code of business ethics and conduct. If any such actions are instituted against us, we may
  have to terminate employees or others involved and the impact of such termination can result in our experiencing delays and additional
  costs associated with replacing the services being provided. If we are not successful in defending ourselves or asserting our rights,
  those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties,
  damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, FDA debarment,
  contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could
  adversely affect our ability to operate our business and our operating results.
  Macroeconomic pressures in the markets in which we operate, including,
  but not limited to, the effect of the COVID-19 pandemic and the current conflict between Ukraine and Russia may alter the ways in which
  we conduct our business operations and manage our financial capacities.
  To varying degrees, the ways in which we conduct
  our business operations and manage our financial capacities are influenced by macroeconomic conditions that affect companies directly
  involved in or providing services related to the drug and biological product development. For example, real GDP growth, business and investor
  confidence, the COVID-19 pandemic, the conflict between Ukraine and Russia, inflation, employment levels, oil prices, interest rates,
  tax rates, availability of consumer and business financing, housing market conditions, foreign currency exchange rate fluctuations, costs
  for items such as fuel and food and other macroeconomic trends can adversely affect not only our decisions and ability to engage in research
  and development and clinical trials, but also those of our management, employees, third-party contractors, manufacturers and suppliers,
  competitors, stockholders and regulatory authorities. In addition, geopolitical issues around the world and how our markets are positioned
  can also impact the macroeconomic conditions and could have a material adverse impact on our financial results.
  87
  Economic uncertainty may adversely affect our access to capital,
  cost of capital and ability to execute our business plan as scheduled.
  Generally, worldwide economic conditions remain
  uncertain. Access to capital markets is critical to our ability to operate. Traditionally, biotechnology companies have funded their research
  and development expenditures through raising capital in the equity markets. Declines and uncertainties in these markets in the past have
  severely restricted raising new capital and have affected companies' ability to continue to expand or fund existing research and
  development efforts. We require significant capital for research and development for our vaccine candidates and clinical trials. The general
  economic and capital market conditions, both in the U.S. and worldwide, have been volatile in the past and at times have adversely
  affected our access to capital and increased the cost of capital. There is no certainty that the capital and credit markets will be available
  to raise additional capital on favorable terms. If economic conditions become worse, our future cost of equity or debt capital and access
  to the capital markets could be adversely affected. In addition, if we are unable to access the capital markets on favorable terms, our
  ability to execute our business plan as scheduled would be compromised. Moreover, we rely and intend to rely on third-parties, including
  clinical research organizations, contract manufacturing organizations and other important vendors and consultants. Global economic conditions
  may result in a disruption or delay in the performance of our third-party contractors and suppliers. If such third-parties are unable
  to adequately satisfy their contractual commitments to us in a timely manner, our business could be adversely affected.
  We may be subject to legal proceedings that may adversely affect
  our Securities.
  On April 15, 2022, the Company received a demand
  letter (the "Demand Letter") from Boustead Securities, LLC ("Boustead"), the Company's underwriter in its
  initial public offering. The Demand Letter alleges that the Company breached the underwriting agreement (the "Underwriting Agreement")
  entered into between Boustead and the Company, dated February 17, 2022 in connection with the Company's IPO. The Demand Letter alleges
  that, by engaging Wainwright as placement agent in the Private Placement, the Company breached the right of first refusal to act as placement
  agent granted to Boustead under the Underwriting Agreement and, as a result of selling securities in the Private Placement, breached the
  12-month lock-up obligation following the consummation of the initial public offering under the Underwriting Agreement. The Demand Letter
  requested that the Company rescind the Private Placement. The Company has not responded to the Demand Letter and no legal action has been
  brought by Boustead to date. There can be no assurance as to whether any litigation will be commenced against the Company with respect
  to the demand letter or that, if any such litigation is commenced, the Company will not incur material losses due to damages, penalties,
  costs and/or expenses as a result of such litigation or that any such losses will not have a material impact on the Company's financial
  condition or results of operations.
  Risks Related to Our Intellectual Property
  It is difficult and costly to protect our proprietary rights,
  and we may not be able to ensure their protection. If our patent position does not adequately protect our product candidates, others could
  compete against us more directly, which would harm our business, possibly materially.
  Our commercial success will depend in part on
  obtaining and maintaining patent protection and trade secret protection of our current product candidates and future product candidates,
  the processes used to manufacture them and the methods for using them, as well as successfully defending these patents against third-party challenges.
  Our ability to stop third parties from making, using, selling, offering to sell or importing our product candidates is dependent upon
  the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.
  The patent positions of biotechnology and pharmaceutical
  companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
  No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the U.S. or in foreign
  jurisdictions outside of the U.S. Changes in either the patent laws or interpretations of patent laws in the U.S. and other
  countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be enforced
  in the patents that may be issued from the applications we currently license or may in the future own or license from third parties. Further,
  if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize or license our product candidates
  or technology could be adversely affected.
  Others may file patent applications covering products
  and technologies that are similar, identical or competitive to ours or important to our business. We cannot be certain that any patent
  application owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our
  licensors will not be involved in interference, opposition, re-examination, review, reissue, post grant review or invalidity proceedings
  before U.S. or non-U.S. patent offices. Such proceedings are also expensive and time consuming.
  88
  The degree of future protection for our proprietary
  rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain
  or keep our competitive advantage. For example:
  ●
  others may be able to make compounds that are similar to our product candidates, but that are not covered by the claims of our licensed patents;
  ●
  any patents that we obtain from licensing or otherwise may not provide us with any competitive advantages;
  ●
  any granted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and
  ●
  the patents of others may have an adverse effect on our business.
  We are dependent on licensed intellectual property. If we were
  to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates,
  if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product
  candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license
  rights that are important to our business.
  We do not currently own any patents, and we are
  heavily reliant upon a number of license agreements under which we are granted rights to intellectual property that are important to our
  business and we may need or choose to enter into additional license agreements in the future. Our existing license agreements impose,
  and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations,
  payment of milestones and/or royalties and other obligations. If we fail to comply with our obligations under these agreements, or we
  are subject to a bankruptcy, the licensor may have the right to terminate the license, in which event we would not be able to market products
  covered by the license. Our business could suffer, for example, if any current or future licenses terminate, if the licensors fail to
  abide by the terms of the license, if the licensed patents or other rights are found to be invalid or unenforceable, or if we are unable
  to enter into necessary licenses on acceptable terms.
  Licensing of intellectual property is of critical
  importance to our business and involves complex legal, business and scientific issues. Disputes may arise between us and our licensors
  regarding intellectual property subject to a license agreement, including:
  ●
  the scope of rights granted under the license agreement and other interpretation-related issues;
  ●
  whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
  ●
  our right to sublicense patent and other rights to third parties;
  ●
  our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations;
  ●
  our obligation to pursue or license others to pursue development of indications we are not currently pursuing;
  ●
  the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;
  ●
  our right to transfer or assign the license; and
  ●
  the effects of termination.
  If disputes over intellectual property that we
  have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully
  develop and commercialize the affected product candidates.
  We have entered into several licenses to support
  our various programs. Termination of any of these license agreements would have a material adverse impact on our ability to develop and
  commercialize derived products under each respective agreement.
  89
  We may enter into additional licenses to third-party
  intellectual property that are necessary or useful to our business. Our current licenses and any future licenses that we may enter into
  impose various royalty payment, milestone, and other obligations on us. Under some license agreements, we may not control prosecution
  of the licensed intellectual property, or may not have the first right to enforce the intellectual property. In those cases, we may not
  be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance
  fees. If we fail to comply with any of our obligations under a current or future license agreement, the licensor may allege that we have
  breached our license agreement, and may accordingly seek to terminate our license. Termination of any of our current or future licenses
  could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to
  develop and commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business
  prospects. Under some license agreements, termination may also result in the transfer of or granting in rights under certain of our intellectual
  property and information related to the product candidate being developed under the license, such as regulatory information.
  The agreements under which we license intellectual
  property or technology to or from third parties are complex, and certain provisions in such agreements may be susceptible to multiple
  interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope
  of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations
  under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations
  and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current
  licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product
  candidates
  In addition, if our licensors fail to abide by
  the terms of the license, if the licensors fail to prevent infringement by third parties, if the licensed patents or other rights are
  found to be invalid or unenforceable, or if we are unable to enter into necessary licenses on acceptable terms, our business could suffer.
  Moreover, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject
  to claims, regardless of their merit, that we are infringing, misappropriating or otherwise violating the licensor's rights.
  Similarly, if we are unable to successfully obtain
  rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have
  to seek alternative options, such as developing new product candidates with design-around technologies, which may require more time and
  investment, or abandon development of the relevant research programs or product candidates and our business, financial condition, results
  of operations and prospects could suffer.
  90
  Some of the intellectual property covered by our licenses concerns
  patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications
  will result in granted patents, nor can we predict how long it will take for such patents to be granted.
  Some of intellectual property covered by our licenses
  concerns certain, specified patent rights (including patent applications, provisional patent applications and PCT patent applications).
  While in some instances, the licensors have agreed to assume responsibility for the preparation, filing, prosecution and maintenance of
  patent applications covered by the licensed patent rights, we cannot be certain as to when or if final patents will be issued for those
  patent applications covered by the licensed patent rights. However, the licensors may not successfully prosecute certain patent applications,
  the prosecution of which they control, under which we are only a licensee and on which our business substantially depends. Even if patents
  issue from these applications, there is no assurance that the patents will be free from defects or survive validity or enforceability
  challenges, the licensors may fail to maintain these patents, may decide not to pursue litigation against third-party infringers, may
  fail to prove infringement or may fail to defend against counterclaims of patent invalidity or unenforceability.
  Moreover, it is possible that the licensed pending
  patent applications will not result in granted patents, and even if such pending patent applications grant as patents, they may not provide
  a basis for intellectual property protection of commercially viable vaccine products or may not provide us with any competitive advantages.
  Further, it is possible that, for any of the patents that may be granted in the future, others will design around the licensed patent
  rights or identify methods for preventing or treating infectious diseases that do not concern the rights covered by our licenses. Further,
  we cannot assure investors that other parties will not challenge any patents granted to the licensors or that courts or regulatory agencies
  will hold licensor's patents to be valid or enforceable. We cannot guarantee investors that, if required to defend the covered patents,
  we will have the funds to or be successful in defending challenges made against the licensed patents and patent applications. Any successful
  third-party challenge to the licensed patents could result in the unenforceability or invalidity of such patents, or to such patents being
  interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological or competitive
  advantage over our competitors may be diminished because of these uncertainties.
  Even if patents are issued based on patent applications to which
  we have been granted a license, because the patent positions of pharmaceutical and biotechnology products are complex and uncertain, we
  cannot predict the scope and extent of patent protection for our product candidates.
  Any patents that may be issued based on patent
  applications that we have been granted licenses to will not ensure sufficient protection with respect to our activities for a number of
  reasons, including without limitation the following:
  ●
  any issued patents may not be broad or strong enough to prevent competition from other vaccine products including identical or similar products;
  ●
  if patents are not issued or if issued patents expire, there would be no protections against competitors making generic equivalents;
  ●
  there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;
  ●
  there may be other patents existing, now or in the future, in the patent landscape for our product candidates that we seek to commercialize or develop, if any, that will affect our freedom to operate;
  ●
  if patents that we have been granted licenses to are challenged, a court could determine that they are not valid or enforceable;
  ●
  a court could determine that a competitor's technology or product does not infringe patents that we have been granted licenses to;
  ●
  patents to which we have been granted licenses could irretrievably lapse due to failure to pay fees or otherwise comply with regulations, or could be subject to compulsory licensing; and
  ●
  if we encounter delays in our development or clinical trials, the period of time during which we could market our products under patent protection would be reduced.
  91
  Obtaining and maintaining patent protection depends on compliance
  with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection
  could be reduced or eliminated for noncompliance with these requirements.
  Periodic maintenance fees on any issued patent
  are due to be paid to the United States Patent and Trademark Office (USPTO) and foreign Intellectual Property Offices in several
  stages over the term of the patent. Maintenance fees are also due for pending patent applications in some countries. The USPTO and various
  foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
  during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means
  in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent
  or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that
  could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to office actions
  within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, our
  competitors might be able to enter the market, which would have a material adverse effect on our business.
  The life of patent protection is limited, and third parties could
  develop and commercialize products and technologies similar or identical to ours and compete directly with us after the patent licensed
  to us expires, which could materially and adversely affect our ability to commercialize our products and technologies.
  The life of a patent and the protection it affords
  is limited. For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally
  20 years from its earliest U.S. non-provisional filing date. In Europe, the expiration of an invention patent is 20 years
  from its filing date. Even if we successfully obtain patent protection for an approved vaccine candidate, it may face competition from
  biosimilar medications. Manufacturers of biosimilar drugs may challenge the scope, validity or enforceability of the patents underlying
  our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectual
  property rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materially
  adversely affect any potential sales of that product.
  Given the amount of time required for the development,
  testing and regulatory review of new vaccine candidates, patents protecting such vaccine candidates might expire before or shortly after
  such vaccine candidates are commercialized. As a result, the patents and patent applications licensed to us may not provide us with sufficient
  rights to exclude others from commercializing products similar or identical to ours. Even if we believe that the patents involved are
  eligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including the
  FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensions
  are available, and such authorities may refuse to grant extensions to such patents, or may grant more limited extensions than requested.
  For example, depending upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop,
  one or more of the U.S. patents licensed to us may be eligible for limited patent term extension under the Drug Price Competition
  and Patent Term Restoration Action of 1984, or Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of
  up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend
  the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and
  only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we may
  not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process,
  failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy
  applicable requirements.
  Moreover, the applicable time period or the scope
  of patent protection afforded could be less than requested. If we are unable to obtain patent term extension or term of any such extension
  is less than requested, our competitors may obtain approval of competing products following our patent expiration, and our business could
  be harmed. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish
  the value of our patents or narrow the scope of our patent protection.
  The patents and pending patent applications licensed
  to us for our product candidates are expected to expire on various dates. Upon the expiration, we will not be able to assert such licensed
  patent rights against potential competitors, which would materially adversely affect our business, financial condition, results of operations
  and prospects.
  92
  We may need to license intellectual property from third parties,
  and such licenses may not be available or may not be available on commercially reasonable terms or at all.
  There may be intellectual property rights existing
  now, or in the future, relevant to our product candidates that we seek to commercialize or develop, if any, that may affect our ability
  to commercialize such product candidates. Although the Company is not aware of any such intellectual property rights, a third-party may
  hold intellectual property rights, including patent rights, that are important or necessary to the development or manufacture of our product
  candidates. Even if all our main product candidates are covered by patents, it may be necessary for us to use the patented or proprietary
  technology of third parties to commercialize our product candidates, in which case we would be required to obtain a license from these
  third parties. Such a license may not be available on commercially reasonable terms, or at all, and we could be forced to accept unfavorable
  contractual terms. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates,
  or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical
  or commercial basis. If we are unable to do so, our business could be harmed.
  The licensing or acquisition of third-party intellectual
  property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third party
  intellectual property rights that we may consider attractive or necessary. These established companies may have a competitive advantage
  over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies
  that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third
  party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable
  to successfully obtain rights to required third party intellectual property rights or maintain the existing intellectual property rights
  we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on
  our business, financial condition, results of operations, and prospects.
  We may infringe the intellectual property rights of others, which
  may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product
  candidates.
  Our success will depend in part on our ability
  to operate without infringing the proprietary rights of third parties. We are not aware of any third party proprietary rights that our
  planned products will infringe or misappropriate, but we have not conducted any freedom to operate study as we are in the earliest stages
  of development. We thus cannot guarantee that our product candidates, or manufacture or use of our product candidates, will not infringe
  third-party patents. Furthermore, a third party may claim that we are using inventions covered by the third party's patent
  rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates.
  These lawsuits are costly and could affect our results of operations and divert the attention of managerial and scientific personnel.
  Some of these third parties may be better capitalized and have more resources than us. There is a risk that a court would decide that
  we are infringing the third party's patents and would order us to stop the activities covered by the patents. In that event, we
  may not have a viable way around the patent and may need to halt commercialization of our product candidates. In addition, there is a
  risk that a court will order us to pay the other party damages for having violated the other party's patents. In addition, we may
  be obligated to indemnify our licensors and collaborators against certain intellectual property infringement claims brought by third parties,
  which could require us to expend additional resources. The pharmaceutical and biotechnology industries have produced a proliferation of
  patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of
  use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
  If we are sued for patent infringement, we would
  need to demonstrate that our product candidates or methods either do not infringe the patent claims of the relevant patent or that the
  patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult. For example, in the U.S., proving invalidity
  requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are
  successful in these proceedings, we may incur substantial costs and diversion of management's time and attention in pursuing these
  proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may
  be required to seek a license, which may not be available, defend an infringement action or challenge the validity of the patents in court.
  Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion.
  In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully
  or have infringed patents declared invalid, we may incur substantial monetary damages, encounter significant delays in bringing our product
  candidates to market and be precluded from manufacturing or selling our product candidates.
  Some of our competitors may be able to sustain
  the costs of complex patent litigation more effectively than us or the third parties from whom we license intellectual property because
  they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation
  could have a material adverse effect on our ability to raise the funds necessary to continue our operations.
  93
  We may become involved in lawsuits to protect or enforce our
  intellectual property, which could be expensive, time consuming and unsuccessful.
  In addition to the possibility of litigation relating
  to infringement claims asserted against it, we may become a party to other patent litigation and other proceedings, including
  inter
  partes
  review proceedings, post-grant review proceedings, derivation proceedings declared by the USPTO and similar proceedings in
  foreign countries, regarding intellectual property rights with respect to our current or future technologies or product candidates or
  products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our
  competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially
  greater financial resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties resulting
  from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace.
  Competitors may infringe or otherwise violate
  our intellectual property, including patents that may issue to or be licensed by us. As a result, we may be required to file claims in
  an effort to stop third-party infringement or unauthorized use. Any such claims could provoke these parties to assert counterclaims against
  us, including claims alleging that we infringe their patents or other intellectual property rights, and/or that any of our intellectual
  property, including licensed intellectual property, is invalid and/or unenforceable. This can be prohibitively expensive, particularly
  for a company of our size, and time-consuming, and even if we are successful, any award of monetary damages or other remedy we may receive
  may not be commercially valuable. In addition, in an infringement proceeding, a court may decide that our asserted intellectual property
  is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our intellectual
  property does not cover its technology. An adverse determination in any litigation or defense proceedings could put our intellectual property
  at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.
  If the breadth or strength of our patent or other
  intellectual property rights is compromised or threatened, it could allow third parties to exploit and, in particular, commercialize our
  technology or products or result in our inability to exploit and/or commercialize our technology and products without infringing third-party
  intellectual property rights. Further, third parties may be dissuaded from collaborating with us.
  Interference or derivation proceedings brought
  by the USPTO or its foreign counterparts may be necessary to determine the priority of inventions with respect to our patent applications,
  and we may also become involved in other proceedings, such as re-examination proceedings, before the USPTO or its foreign counterparts.
  Due to the substantial competition in the pharmaceutical space, the number of such proceedings may increase. This could delay the prosecution
  of our pending patent applications or impact the validity and enforceability of any future patents that we may obtain. In addition, any
  such litigation, submission or proceeding may be resolved adversely to us and, even if successful, may result in substantial costs and
  distraction to our management.
  If we are not able to adequately prevent disclosure of trade
  secrets and other proprietary information, the value of our technology and product could be significantly diminished.
  We also rely on trade secrets to protect our proprietary
  technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult
  to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored
  researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent
  disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential
  information. In addition, others may independently discover our trade secrets and proprietary information. For example, the FDA, as part
  of its transparency initiative, is currently considering whether to make additional information publicly available on a routine basis,
  including information that we may consider to be trade secrets or other proprietary information, and it is not clear at the present time
  how the FDA's disclosure policies may change in the future, if at all. Costly and time-consuming litigation could be necessary
  to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely
  affect our competitive business position.
  We may be subject to claims that our employees or consultants
  have wrongfully used or disclosed alleged trade secrets.
  As is common in the biotechnology and pharmaceutical
  industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors
  or potential competitors. Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of
  others in their work for us, we may be subject to claims that we or our employees or consultants have inadvertently or otherwise used
  or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these
  claims. If we fail in defending any such claims, in addition to paying monetary damages, we could lose valuable intellectual property
  rights or personnel, which could adversely impact our business. Even if we are successful in defending against these claims, litigation
  could result in substantial costs and be a distraction to management.
  94
  Our intellectual property may not be sufficient to protect our
  product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.
  We may be subject to competition despite the existence
  of intellectual property we license or may in the future own. We can give no assurances that our intellectual property claims will be
  sufficient to prevent third parties from designing around patents we own or license and developing and commercializing competitive products.
  The existence of competitive products that avoid our intellectual property could materially adversely affect our operating results and
  financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit the interest of third
  parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable risk to commercialization
  of our product candidates or future product candidates.
  We may elect to sue a third party, or otherwise
  make a claim, alleging infringement or other violation of patents, trademarks, trade dress, copyrights, trade secrets, domain names or
  other intellectual property rights that we either own or license from a third party. If we do not prevail in enforcing our intellectual
  property rights in this type of litigation, we may be subject to:
  ●
  paying monetary damages related to the legal expenses of the third party;
  ●
  facing additional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial condition, and the commercial viability of our product; and
  ●
  restructuring our company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical trial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.
  A third party may also challenge the validity,
  enforceability or scope of the intellectual property rights that we license or own and the result of these challenges may narrow the scope
  or claims of or invalidate patents that are integral to our product candidates in the future. There can be no assurance that we will be
  able to successfully defend patents we own or license in an action against third parties due to the unpredictability of litigation and
  the high costs associated with intellectual property litigation, amongst other factors.
  Intellectual property rights may be less extensive
  and enforcement more difficult in jurisdictions outside of the U.S. Therefore, we may not be able to protect our intellectual property
  and third parties may be able to market competitive products that may use some or all of our intellectual property.
  Changes to patent law, including the Leahy-Smith America
  Invests Act of 2011 and the Patent Reform Act of 2009 and other future article of legislation, may substantially change
  the regulations and procedures surrounding patent applications, issuance of patents and prosecution of patents. We can give no assurances
  that the patents of our licensor can be defended or will protect us against future intellectual property challenges, particularly as they
  pertain to changes in patent law and future patent law interpretations.
  Risks Related to Healthcare Compliance and Other Regulations
  If we fail to comply with healthcare regulations, we could face
  substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be
  adversely affected.
  We could be subject to healthcare fraud and abuse
  laws and patient privacy laws of both the federal government and the states in which we conduct our business. The laws include:
  ●
  the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
  ●
  federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;
  95
  ●
  HIPAA which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
  ●
  the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; and
  ●
  state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.
  If our operations are found to be in violation
  of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including civil and
  criminal penalties, damages, fines and the curtailment or restructuring of our operations. Any penalties, damages, fines, curtailment
  or restructuring of our operations could adversely affect our ability to operate our business and our financial results. Although compliance
  programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated.
  Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal
  expenses and divert management's attention from the operation of our business. Moreover, achieving and sustaining compliance with
  applicable federal and state privacy, security and fraud laws may prove costly.
  Healthcare reform in the United States has been implemented
  in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry.
  Violations of healthcare laws can have an adverse impact on our ability to advance our product candidates and our operating results.
  In the United States, there have been, and
  continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the future
  results of pharmaceutical manufactures' operations. In particular, there have been and continue to be a number of initiatives at
  the federal and state levels that seek to reduce healthcare costs. For example, the Affordable Care Act, or the ACA, which was originally
  enacted in March 2010 and subsequently amended, includes measures to significantly change the way healthcare is financed by both
  governmental and private insurers. Among the provisions of the ACA of greatest importance to the pharmaceutical and biotechnology industry
  are the following:
  ●
  an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
  ●
  implementation of the federal physician payment transparency requirements, sometimes referred to as the "Physician Payments Sunshine Act";
  ●
  a licensure framework for follow-on biologic products;
  ●
  a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
  ●
  establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;
  ●
  an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;
  ●
  a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
  ●
  extension of manufacturers' Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
  ●
  expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers' Medicaid rebate liability;
  96
  ●
  a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D; and
  ●
  expansion of the entities eligible for discounts under the Public Health program.
  Some of the provisions of the ACA have yet to
  be implemented, and there have been legal and political challenges to certain aspects of the ACA. The former Trump administration
  issued certain executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA. Concurrently,
  Congress considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed repeal
  legislation, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared
  responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a
  year that is commonly referred to as the "individual mandate." Congress may consider other legislation to repeal or replace
  elements of the ACA.
  Many of the details regarding the implementation
  of the ACA are yet to be determined, and at this time, the full effect that the ACA would have on a pharmaceutical manufacturer remains
  unclear. In particular, there is uncertainty surrounding the applicability of the biosimilars provisions under the ACA. This uncertainty
  is heightened by President Biden's January 28, 2021 Executive Order on Strengthening Medicaid and the Affordable Care Act,
  which indicates that the Biden administration may significantly modify the ACA and potentially revoke any changes implemented by the Trump
  administration.
  The FDA has issued several guidance documents,
  but no implementing regulations, on biosimilars. A number of biosimilar applications have been approved over the past few years.
  The regulations that are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical
  manufacturers conduct their business and may require changes to current strategies. A biosimilar is a biological product that is highly
  similar to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically
  meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the product.
  Individual states have become increasingly aggressive
  in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price
  or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency
  measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by
  third-party payors or other restrictions could harm a pharmaceutical manufacturer's business, results of operations, financial condition
  and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
  what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could
  reduce ultimate demand for certain products or put pressure product pricing, which could negatively affect a pharmaceutical manufacturer's
  business, results of operations, financial condition and prospects.
  It is also possible that President Biden will
  further reform the ACA and other federal programs in a manner that may impact our operations. For example, the Biden administration has
  indicated that a goal of its administration is to expand and support Medicaid and the ACA and to make high-quality healthcare accessible
  and affordable. The potential increase in patients covered by government funded insurance may impact our pricing. Further, it is possible
  that the Biden administration may further increase the scrutiny on drug pricing.
  In addition, given recent federal and state government
  initiatives directed at lowering the total cost of healthcare, the Biden administration, Congress and state legislatures will likely continue
  to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. For
  example, there have been several recent U.S. congressional inquiries and proposed federal and proposed and enacted state legislation
  designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient
  programs, reduce the costs of drugs under Medicare and reform government program reimbursement methodologies for drug products. Further,
  in July 2020, former President Trump issued a number of executive orders that are intended to lower the costs of prescription drug
  products including one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts
  for plans, pharmacies, and pharmaceutical benefit managers. No assurance can be given whether these orders will remain in effect under
  the Biden administration.
  While no one can predict the full outcome of any
  such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure
  to reduce prescription drug prices. This could harm a pharmaceutical manufacturer's ability to generate revenue. Increases in importation
  or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure
  on a pharmaceutical manufacturer's ability to profitably price products, which, in turn, could adversely affect business, results
  of operations, financial condition and prospects. A pharmaceutical manufacturer might elect not to seek approval for or market products
  in foreign jurisdictions in order to minimize the risk of re-importation, which could also reduce the revenue generated from
  product sales. It is also possible that other legislative proposals having similar effects will be adopted.
  97
  Furthermore, regulatory authorities' assessment
  of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many factors, such as
  the emergence of new information, including on other products, changing policies and agency funding, staffing and leadership. We cannot
  be sure whether future changes to the regulatory environment will be favorable or unfavorable to our business prospects. For example,
  average review times at the FDA for marketing approval applications can be affected by a variety of factors, including budget and funding
  levels and statutory, regulatory and policy changes.
  Our employees may engage in misconduct or other
  improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us
  and harm our reputation.
  We are exposed to the risk of employee fraud or
  other misconduct, including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory
  authorities, provide accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards
  we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established
  and enforced by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities
  to us. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result
  in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the
  precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in
  protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
  or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,
  those actions could have a significant impact on our business and results of operations, including the imposition of significant civil,
  criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare
  and Medicaid, and integrity oversight and reporting obligations.
  We may rely on government funding and collaboration with government
  entities for our vaccine development, which adds uncertainty to our research and development efforts and may impose requirements that
  increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
  Because we anticipate the resources necessary to develop our vaccine
  product candidates will be substantial, we may explore funding and development collaboration opportunities with the U.S. government
  and its agencies. For example, we may apply for certain grant funding from BARDA, the NIH or other government agencies to further the
  research, development, manufacture, testing, and regulatory approval of our vaccine product candidates. We have no control or input over
  whether an application for BARDA grant funding or any other funding will be accepted or approved, in full or in part, and we cannot provide
  investors with any assurances that we will receive such funding.
  Contracts and grants funded by the U.S. government
  and its agencies, contain provisions that reflect the government's substantial rights and remedies, many of which are not typically
  found in commercial contracts, including powers of the government to:
  ●
  reduce or modify the government's obligations under such agreements without the consent of the other party;
  ●
  claim rights, including Intellectual Property rights, in products and data developed under such agreements;
  ●
  audit contract-related costs and fees, including allocated indirect costs;
  ●
  suspend the contractor or grantee from receiving new contracts pending resolution of alleged violations of procurement laws or regulations.
  ●
  impose U.S. manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
  ●
  suspend or debar the contractor or grantee from doing future business with the government;
  ●
  control and potentially prohibit the export of products;
  ●
  pursue criminal or civil remedies under the False Claims Act, False Statements Act, and similar remedy provisions specific to government agreements; and
  ●
  limit the government'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.
  98
  If we received such grants or agreements, we may
  not have the right to prohibit the U.S. government from using certain technologies developed by us, and we may not be able to prohibit
  third-parties, including our competitors, from using those technologies in providing products and services to the U.S. government.
  Further, under such agreements we could be subject to obligations to and the rights of the U.S. government set forth in the Bayh-Dole
  Act of 1980, meaning the U.S. government may have rights in certain inventions developed under these government-funded
  agreements, including a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose.
  In addition, the U.S. government could have the right to require us to grant exclusive, partially exclusive, or nonexclusive licenses
  to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention;
  (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements
  for public use under federal regulations, also referred to as "march-in rights." Although the U.S. government's
  historic restraint with respect to these rights indicates they are unlikely to be used, any exercise of the march-in rights could harm
  our competitive position, business, financial condition, results of operations, and prospects. In the event we would be subject to the
  U.S. government's exercise such march-in rights, we may receive compensation that is deemed reasonable by the U.S. government
  in its sole discretion, which may be less than what we might be able to obtain in the open market.
  Additionally, the U.S. government requires
  that any products embodying any invention generated through the use of U.S. government funding be manufactured substantially in the
  United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable
  but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture
  substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference
  for U.S. manufacturers may limit our ability to contract with non-U.S. manufacturers for products covered by such intellectual
  property.
  Although we may need to comply with some of these
  obligations, not all of the aforementioned obligations may be applicable to us unless and only to the extent that we receive a government
  grant, contract or other agreement. However, as an organization, we are relatively new to government contracting and new to the regulatory
  compliance obligations that such contracting entails. If we were to fail to maintain compliance with those obligations, we may be subject
  to potential liability and to termination of our contracts, which may have a materially adverse effect on our ability to develop our vaccine
  product candidates.
  We are subject to U.S. and certain foreign export and import
  controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal
  standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious
  consequences for violations, which can harm our business.
  We are subject to export control and import laws
  and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade
  sanctions regulations administered by the U.S. Treasury Department's Office of Foreign Assets Controls, the U.S. Foreign
  Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel
  Act, the USA PATRIOT Act and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct
  activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other
  collaborators from authorizing, promising, offering or providing, directly or indirectly, improper payments or anything else of value
  to recipients in the public or private sector. We may engage third parties for clinical trials outside of the United States,
  to sell our products abroad once we enter a commercialization phase and/or to obtain necessary permits, licenses, patent registrations,
  and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated
  hospitals, universities and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents,
  contractors and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations
  of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of
  export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.
  Risks Related to Owning our Common Stock
  The market price of our common stock has been extremely volatile
  and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their
  investment.
  The market price of our common stock may be highly
  volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, which include:
  ●
  whether we achieve our anticipated corporate objectives;
  ●
  actual or anticipated fluctuations in our financial condition and operating results;
  ●
  changes in financial or operational estimates or projections;
  ●
  the development status of our product candidates and when our products receive regulatory approval;
  99
  ●
  our execution of our sales and marketing, manufacturing and other aspects of our business plan;
  ●
  performance of third parties on whom we rely to manufacture our products, product components and product candidates, including their ability to comply with regulatory requirements;
  ●
  the results of our clinical studies and clinical trials;
  ●
  results of operations that vary from those of our competitors and the expectations of securities analysts and investors;
  ●
  changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;
  ●
  our announcement of significant contracts, acquisitions or capital commitments;
  ●
  announcements by our competitors of competing products or other initiatives;
  ●
  announcements by third parties of significant claims or proceedings against us;
  ●
  regulatory and reimbursement developments in the United States and abroad;
  ●
  future sales of our common stock;
  ●
  product liability claims;
  ●
  healthcare reform measures in the United States;
  ●
  additions or departures of key personnel; and
  ●
  general economic or political conditions in the United States or elsewhere.
  In addition, the stock market in general, and the
  stock of medical biotechnology companies like ours, in particular, have experienced extreme price and volume fluctuations that have often
  been unrelated or disproportionate to the operating performance of the issuer. For example, on March 15, 2022 and April 29, 2022, the
  closing price of our common stock on Nasdaq was $67.90 and $3.59, respectively, and daily trading volume on these days was approximately
  12,500 and 988,500 shares, respectively. Additionally, our intraday trading prices have experienced extreme fluctuation. For example,
  on March 16, 2022, the difference between our high and low trading price was $46.49 and on February 22, 2022, the difference between our
  high and low trading price was $40.80 and from February 18, 2022 (the date our shares were initially listed on Nasdaq) to the date hereof,
  the market price of our common stock has fluctuated from an intra-day low on Nasdaq of $3.26 on May 2, 2022 to an intra-day high of $90.90
  per share on February 22, 2022. By comparison, our initial public offering, which closed on February 23, 2022, was conducted at $9.00
  per share. During this time, we have made one announcement regarding certain research developments for our vaccine candidates. Notwithstanding
  the foregoing, since our initial public offering on February 18, 2022, there were no material recent publicly disclosed changes in the
  financial condition or results of operations of the Company, such as our earnings or revenue, that are consistent with or related to the
  changes in our stock price. These broad market fluctuations may adversely affect the trading price of our common stock. In particular,
  a proportion of our common stock may be traded by short sellers which may put pressure on the supply and demand for our common stock,
  further influencing volatility in its market price. Additionally, these and other external factors have caused and may continue to cause
  the market price and demand for our common stock to fluctuate, which may limit or prevent investors from readily selling their shares
  of common stock and may otherwise negatively affect the liquidity of our common stock. While the market price of our common stock may
  respond to developments regarding operating performance and prospects, expansion plans, developments regarding our participation in direct
  contracting, the impacts of COVID-19, and developments regarding our industry, we believe that the extreme volatility we experienced in
  recent periods reflects market and trading dynamics unrelated to our underlying business, our actual or expected operating performance,
  our financial condition, or macro or industry fundamentals, and we do not know if these dynamics will continue or how long they will last
  .. Under these circumstances, we caution you against investing in our common stock, unless you are prepared to incur the risk of losing
  all or a substantial portion of your investment.
  We may be subject to securities litigation, which is expensive
  and could divert our management's attention.
  The market price of our securities may be volatile,
  and in the past, companies that have experienced volatility in the market price of their securities have been subject to securities class
  action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial
  costs and divert our management's attention from other business concerns, which could seriously harm our business.
  100
  Our Amended and Restated Certificate of Incorporation requires,
  to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers, other employees
  or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in the State of Delaware
  and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service of process on such
  stockholder's counsel, which may have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders.
  Our Amended and Restated Certificate of Incorporation
  requires, to the fullest extent permitted by law, that derivative actions brought in our name, actions against our directors, officers,
  other employees or stockholders for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in
  the State of Delaware and, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service
  of process on such stockholder's counsel except any action (A) as to which the Court of Chancery in the State of Delaware determines
  that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent
  to the personal jurisdiction of the Court of Chancery within ten days following such determination), (B) which is vested in
  the exclusive jurisdiction of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have
  subject matter jurisdiction, or (D) any action arising under the Securities Act, as to which the Court of Chancery and the federal
  district court for the District of Delaware shall have concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring
  any interest in shares of our capital stock shall be deemed to have notice of and consented to the forum provisions in our Amended and
  Restated Certificate of Incorporation. This choice of forum provision may make it more costly for a stockholder to bring a claim, and
  it may also limit a stockholder's ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any
  of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although our stockholders
  cannot waive our compliance with federal securities laws and the rules and regulations thereunder. Alternatively, if a court were to find
  the choice of forum provision contained in our Amended and Restated Certificate of Incorporation to be inapplicable or unenforceable in
  an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business,
  operating results and financial condition.
  Our Amended and Restated Certificate of Incorporation
  provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law. Section 27 of the
  Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act
  or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty
  or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. In addition,
  our Amended and Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative forum,
  the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum
  for the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended, or the
  rules and regulations promulgated thereunder. We note, however, that there is uncertainty as to whether a court would enforce this provision
  and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section 22
  of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability
  created by the Securities Act or the rules and regulations thereunder.
  Our principal stockholders and management own a significant percentage
  of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to stockholders
  for approval.
  As of June 6, 2022, our officers and directors,
  together with holders of 5% or more of our outstanding common stock and their respective affiliates, beneficially own or control 9,248,368
  shares of our common stock, which in the aggregate represents approximately 75.6% of the outstanding shares of our common stock. As a
  result, if some of these persons or entities act together, they will have the ability to exercise significant influence over matters submitted
  to our stockholders for approval, including the election and removal of directors, amendments to our Amended and Restated Certificate
  of Incorporation and Amended and Restated Bylaws, the approval of any business combination and any other significant corporate transaction.
  These actions may be taken even if they are opposed by other stockholders. This concentration of ownership may also have the effect of
  delaying or preventing a change of control of our company or discouraging others from making tender offers for our shares, which could
  prevent our stockholders from receiving a premium for their shares. Some of these persons or entities who make up our principal stockholders
  may have interests different from yours.
  There can be no assurance that we will be able to comply with
  the continued listing standards of Nasdaq.
  Our continued eligibility for listing on Nasdaq
  depends on our ability to comply with Nasdaq's continued listing requirements. If Nasdaq delists the common stock from trading on
  its exchange for failure to meet the listing standards, we and our stockholders could face significant material adverse consequences including:
  ●
  a limited availability of market quotations for our securities;
  ●
  a determination that our common stock is a "penny stock," which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock;
  101
  ●
  a limited amount of analyst coverage; and
  ●
  a decreased ability to issue additional securities or obtain additional financing in the future.
  If our shares become subject to the penny stock rules, it would
  become more difficult to trade our shares.
  The SEC has adopted rules that regulate broker-dealer
  practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a price of less than $5.00,
  other than securities registered on certain national securities exchanges or authorized for quotation on certain automated quotation systems,
  provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system.
  If we do not retain a listing on Nasdaq and if the price of our common stock is less than $5.00, our common stock will be deemed a penny
  stock. The penny stock rules require a broker-dealer, before a transaction in a penny stock not otherwise exempt from those rules, to
  deliver a standardized risk disclosure document containing specified information. In addition, the penny stock rules require that before
  effecting any transaction in a penny stock not otherwise exempt from those rules, a broker-dealer must make a special written determination
  that the penny stock is a suitable investment for the purchaser and receive (i) the purchaser's written acknowledgment of the
  receipt of a risk disclosure statement; (ii) a written agreement to transactions involving penny stocks; and (iii) a signed
  and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity
  in the secondary market for our common stock, and therefore stockholders may have difficulty selling their shares.
  Future sales of our shares by existing stockholders could cause
  our stock price to decline.
  If we or our existing stockholders, directors
  and officers sell, or indicate an intent to sell, substantial amounts of our common stock or securities convertible into our common stock
  in the public market after February 17, 2023 in the case of the Company and after August 16, 2022 in the case of directors, officers and
  stockholders, contractual lock-up and other legal restrictions on resale in connection with our initial public offering lapse, the trading
  price of our common stock could decline significantly. Based on 12,229,399 shares of common stock outstanding as of June 6, 2022, 3,403,034
  shares of common stock are freely tradable, without restriction, in the public market. If our existing stockholders sell substantial amounts
  of our common stock in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on
  the market price of our common stock, even if there is no relationship between such sales and the performance of our business. We also
  intend to register all shares of common stock that we may issue under our equity compensation plan. Once we register these shares, they
  can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.
  After the lock-up agreements pertaining to our
  initial public offering expire, an additional 8,826,365 shares will be eligible for sale in the public market. In addition, upon issuance,
  the 1,475,180 shares subject to outstanding options under our stock option plan and the shares reserved for future issuance under our
  stock option plan will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.
  If our existing stockholders sell substantial amounts of our common stock in the public market, or if the public perceives that such sales
  could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such
  sales and the performance of our business.
  We are an "emerging growth company" and the reduced
  disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.
  We are an "emerging growth company,"
  as defined in the JOBS Act. We may remain an "emerging growth company" until as late as December 31, 2027 (the fiscal
  year-end following the fifth anniversary of the completion of our initial public offering), though we may cease to be an "emerging
  growth company" earlier under certain circumstances, including (1) if the market value of our common stock that is held by
  nonaffiliates exceeds $700 million as of any June 30, in which case we would cease to be an "emerging growth company"
  as of the following December 31, or (2) if our gross revenue exceeds $1.07 billion in any fiscal year. "Emerging
  growth companies" may take advantage of certain exemptions from various reporting requirements that are applicable to other public
  companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
  Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from
  the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments
  not previously approved. Investors could find our common stock less attractive because we may rely on these exemptions. If some investors
  find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price
  may be more volatile.
  In addition, Section 102 of the JOBS Act
  also provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of
  the Securities Act, for complying with new or revised accounting standards. An "emerging growth company" can therefore delay
  the adoption of certain accounting standards until those standards would otherwise apply to private companies.
  102
  We are subject to increased costs as a result of operating as
  a public company, and our management is required to devote substantial time to new compliance initiatives.
  As a public company, we incur significant legal,
  accounting and other expenses that we did not incur as a private company, including costs associated with public company reporting requirements.
  The Sarbanes-Oxley Act of 2002, as amended, or Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and The
  Nasdaq Capital Market to implement provisions of the Sarbanes-Oxley Act, impose significant requirements on public companies, including
  requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices.
  Further, in July 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted. There are
  significant corporate governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional
  rules and regulations in these areas, such as "say on pay" and proxy access. Emerging growth companies may implement many
  of these requirements over a longer period of up to five years from the pricing of their initial public offering. We intend to take
  advantage of these extended transition periods but cannot guarantee that we will not be required to implement these requirements sooner
  than budgeted or planned and thereby incur unexpected expenses. Stockholder activism, the current political environment and the current
  high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which
  may lead to additional compliance costs and impact the manner in which we operate our business in ways we cannot currently anticipate.
  Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company
  reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines
  prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote
  additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant
  legal and financial compliance costs and will make some activities more time-consuming and costly.
  To comply with the requirements of being a public
  company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting
  or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control
  over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure
  that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported
  within the time periods specified in SEC rules and forms, and that information required to be disclosed in reports under the Securities
  Exchange Act of 1934, as amended, or the Exchange Act, is accumulated and communicated to our principal executive and financial officers.
  Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial
  reporting may be discovered in the future. Any failure to develop or maintain effective controls when we become subject to this requirement
  could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation
  reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic
  reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, harm our operating results,
  cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that
  we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived
  as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating
  results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may
  not be able to remain listed on Nasdaq.
  The rules and regulations applicable to public
  companies have substantially increased our legal and financial compliance costs and make some activities more time-consuming and costly.
  If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse
  effect on our business, financial condition, and results of operations. The increased costs will decrease our net income and may require
  us to reduce costs in other areas of our business or increase the prices of our products or services. For example, these rules and regulations
  made it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial
  costs in the future to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of additional costs we
  may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain
  qualified persons to serve on our board of directors, our board committees or as executive officers.
  103
  Our management team has limited experience managing a public
  company.
  Most members of our management team have limited
  experience managing a publicly-traded company, interacting with public company investors and complying with the increasingly complex laws
  pertaining to public companies. Our management team may not successfully or efficiently manage our transition to being a public company
  subject to significant regulatory oversight and reporting obligations under the federal securities laws and the continuous scrutiny of
  securities analysts and investors. These new obligations and constituents require significant attention from our senior management and
  could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial
  condition and operating results.
  If we fail to maintain an effective system of internal controls,
  we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our
  business and operating results and cause the trading price of our stock to decline.
  Effective internal controls required under Section 404
  of the Sarbanes-Oxley Act, are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide
  reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed. We have discovered, and may
  in the future discover, areas of our internal controls that need improvement. We cannot be certain that the measures we have taken or
  intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future. Any failure to
  implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions,
  harm our business and operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also harm
  our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the
  trading price of our stock.
  If securities or industry analysts do not publish research, or
  publish inaccurate or unfavorable research, about our business, our stock price and our trading volume could decline.
  The trading market for our common stock depends,
  in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts
  may never publish research on us. If no or few securities or industry analysts commence coverage of us, the price for our common stock
  could be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who cover
  us downgrade our common stock or publish inaccurate or unfavorable research about our business, our stock price could decline. In addition,
  if our operating results fail to meet the forecast of analysts, our stock price could decline. If one or more of these analysts cease
  coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price
  and trading volume to decline.
  Our Amended and Restated Certificate of Incorporation and our
  Amended and Restated Bylaws and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control,
  which may cause our stock price to decline.
  Our Amended and Restated Certificate of Incorporation
  and our Amended and Restated Bylaws and Delaware law could make it more difficult for a third party to acquire us, even if closing such
  a transaction would be beneficial to our stockholders. Our Amended and Restated Certificate of Incorporation authorizes us to issue up
  to 10,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined
  at the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock may
  include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion
  and redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of
  the holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future
  holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve
  control by the present management.
  104
  Provisions of our Amended and Restated Certificate
  of Incorporation, our Amended and Restated Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals
  or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such
  provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, our Amended
  and Restated Certificate of Incorporation, our Amended and Restated Bylaws and Delaware law, as applicable, among other things:
  ●
  provide the board of directors with the ability to alter the bylaws without stockholder approval;
  ●
  place limitations on the removal of directors;
  ●
  establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and
  ●
  provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.
  These provisions, alone or together, could delay
  or prevent hostile takeovers and changes in control or changes in our management.
  As a Delaware corporation, we are also subject
  to provisions of Delaware law, including Section 203 of the Delaware General Corporation law, which prevents certain stockholders
  holding more than 15% of our outstanding capital stock from engaging in certain business combinations without approval of the holders
  of at least two-thirds of our outstanding common stock not held by such stockholder.
  Any provision of our Amended and Restated Certificate
  of Incorporation, Amended and Restated Bylaws or Delaware law that has the effect of delaying, preventing or deterring a change in control
  could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock, and could also affect the
  price that some investors are willing to pay for our common stock.
  We do not anticipate paying any cash dividends on our common
  stock in the foreseeable future and, as such, capital appreciation, if any, of our common stock will be your sole source of gain for the
  foreseeable future.
  We have never declared or paid cash dividends
  on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We currently intend
  to retain all available funds and any future earnings to fund the development and growth of our business. In addition, and any future
  loan arrangements we enter into may contain, terms prohibiting or limiting the amount of dividends that may be declared or paid on our
  common stock. As a result, capital appreciation, if any, of our common stock, which may never occur, will be your sole source of gain
  for the foreseeable future.
  A possible "short squeeze" due to a sudden increase
  in demand of our common stock that largely exceeds supply may lead to price volatility in our common stock.
  Investors may purchase our common stock to hedge
  existing exposure in our common stock or to speculate on the price of our common stock. Speculation on the price of our common stock may
  involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our common stock available for
  purchase in the open market, investors with short exposure may have to pay a premium to repurchase our common stock for delivery to lenders
  of our common stock. Those repurchases may in turn, dramatically increase the price of our common stock until investors with short exposure
  are able to purchase additional common shares to cover their short position. This is often referred to as a "short squeeze."
  A short squeeze could lead to volatile price movements in our common stock that are not directly correlated to the performance or prospects
  of our company and once investors purchase the shares of common stock necessary to cover their short position the price of our common
  stock may decline.
  105
  SELLING STOCKHOLDERS
  The following table sets
  forth (a) the name and position or positions with the Company of each Selling Stockholder; (b) the aggregate of (i) the number of shares
  of Common Stock held by each Selling Stockholder as of the date of this prospectus and (ii) the number of shares issuable upon exercise
  of options granted to each Selling Stockholder under the 2019 Plan and the 2022 Plan that are being registered pursuant to this Registration
  Statement for resale by each Selling Stockholder as of the date of this prospectus; (c) the number of shares of Common Stock issuable
  upon exercise of options that each Selling Stockholder may offer for sale from time to time pursuant to this prospectus, whether or not
  such Selling Stockholder has a present intention to do so; and (d) the number of shares of Common Stock to be beneficially owned by each
  Selling Stockholder following the sale of all shares that may be so offered pursuant to this prospectus, assuming no other change in ownership
  of Common Stock by such Selling Stockholder after the date of this prospectus. Unless otherwise indicated, beneficial ownership is direct
  and the person indicated has sole voting and investment power.
  The Selling Stockholders
  may, from time to time, resell all, a portion or none of the shares of our Common Stock covered by this reoffer prospectus.
  Inclusion of an individual's
  name in the table below does not constitute an admission that such individual is an "affiliate" of the Company.
  Selling Stockholder
  Principal Position with
  the Company (1)
  Shares Owned
  Prior to Resale
  (2)
  Number of Shares
  Offered for Resale
  Shares Beneficially Owned
  After Resale
  Number
  Percent
  Number
  Percent
  Joseph Hernandez
  Chairman and Chief Executive Officer
  3,400,000
  27.35
  %
  200,000
  3,200,000
  25.75
  %
  Erin Henderson
  Chief Business Officer and Secretary
  245,920
  1.97
  %
  245,920
  —
  —
  %
  Jon Garfield
  Chief Financial Officer
  100,000
  *
  %
  100,000
  —
  —
  %
  Kimberly Murphy
  Director
  50,575
  *
  %
  50,575
  —
  —
  %
  Allan Shaw
  Director
  50,575
  *
  %
  50,575
  —
  —
  %
  James Sapirstein
  Director
  50,575
  *
  %
  50,575
  —
  —
  %
  Michael Venerable
  Director
  4,655
  *
  %
  4,655
  —
  —
  %
  Brian Price
  Consultant
  91,840
  *
  %
  91,840
  —
  —
  %
  David Zarley
  Consultant
  45,920
  *
  %
  45,920
  —
  —
  %
  CincyTech Fund IV, LLC
  Consultant
  851,988
  6.94
  %
  45,920
  806,068
  6.57
  %
  Sunetra Gupta
  Advisory Board Member
  459,200
  3.62
  %
  459,200
  —
  —
  %
  *
  Less than 1%.
  (1)
  All positions described are with the Company, unless otherwise indicated.
  (2)
  The number of shares owned prior to resale by each Selling Stockholder shares of Common Stock owned on or about the date hereof by the Selling Stockholders and shares of common stock that are issued or to be issued, or which may be acquired upon the exercise of stock options issued or to be issued, or vesting of restricted stock awards issued or to be issued, pursuant to the 2019 Plan and the 2022 Plan.
  The
  Company may supplement this prospectus from time to time as required by the rules of the Commission to include certain information concerning
  the security ownership of the Selling Stockholders or any new Selling Stockholders, the number of securities offered for resale and the
  position, office or other material relationship which a Selling Stockholder has had within the past three years with the Company or any
  of its predecessors or affiliates.
  106
  USE OF PROCEEDS
  We will not receive any proceeds
  from the resale of our Common Stock by the Selling Stockholders pursuant to this prospectus. However, we will receive the exercise price
  of any Common Stock issued to the Selling Stockholders upon cash exercise by them of their options. We would expect to use these proceeds,
  if any, for general working capital purposes. We have agreed to pay the expenses of registration of these shares.
  PLAN OF DISTRIBUTION
  In this section of the prospectus,
  the term "Selling Stockholder" means and includes:
  ●
  the persons identified in the table above as the Selling Stockholders;
  ●
  those persons whose identities are not known as of the date hereof but may in the future be eligible to receive options under the 2019 Plan or the 2022 Plan; and
  ●
  any of the donees, pledgees, distributees, transferees or other successors in interest of those persons referenced above who may: (a) receive any of the shares of our Common Stock offered hereby after the date of this prospectus and (b) offer or sell those shares hereunder.
  The shares of our Common
  Stock offered by this prospectus may be sold from time to time directly by the Selling Stockholders. Alternatively, the Selling Stockholders
  may from time to time offer such shares through underwriters, brokers, dealers, agents or other intermediaries. The Selling Stockholders
  as of the date of this prospectus have advised us that there were no underwriting or distribution arrangements entered into with respect
  to the Common Stock offered hereby. The distribution of the Common Stock by the Selling Stockholders may be effected: in one or more transactions
  that may take place on The Nasdaq Capital Market (including one or more block transactions) through customary brokerage channels, either
  through brokers acting as agents for the Selling Stockholders, or through market makers, dealers or underwriters acting as principals
  who may resell these shares on The Nasdaq Capital Market; in privately-negotiated sales; by a combination of such methods; or by other
  means. These transactions may be effected at market prices prevailing at the time of sale, at prices related to such prevailing market
  prices or at other negotiated prices. Usual and customary or specifically negotiated brokerage fees or commissions may be paid by the
  Selling Stockholders in connection with sales of our Common Stock.
  The Selling Stockholders
  may enter into hedging transactions with broker-dealers in connection with distributions of the shares or otherwise. In such transactions,
  broker-dealers may engage in short sales of the shares of our Common Stock in the course of hedging the positions they assume with the
  Selling Stockholders. The Selling Stockholders also may sell shares short and redeliver the shares to close out such short positions.
  The Selling Stockholders may enter into option or other transactions with broker-dealers which require the delivery to the broker-dealer
  of shares of our Common Stock. The broker-dealer may then resell or otherwise transfer such shares of Common Stock pursuant to this prospectus.
  At the time a particular
  offering of shares of our Common Stock is made, a prospectus supplement, if required, will be distributed, which will set forth the name
  of the Selling Stockholders, the aggregate amount of shares of our Common Stock being offered and the terms of the offering, including,
  to the extent required, (1) the name or names of any underwriters, broker-dealers or agents, (2) any discounts, commissions and other
  terms constituting compensation from the Selling Stockholders and (3) any discounts, commissions or concessions allowed or reallowed to
  be paid to broker-dealers.
  The Selling Stockholders
  also may lend or pledge shares of our Common Stock to a broker-dealer. The broker-dealer may sell the shares of Common Stock so lent,
  or upon a default the broker-dealer may sell the pledged shares of Common Stock pursuant to this prospectus.
  The Selling Stockholders
  will act independently of us in making decisions with respect to the timing, manner, and size of each resale or other transfer. There
  can be no assurance that the Selling Stockholders will sell any or all of the shares of our Common Stock under this prospectus. Further,
  we cannot assure you that the Selling Stockholders will not transfer, distribute, devise or gift the shares of our Common Stock by other
  means not described in this prospectus. In addition, any Shares covered by this prospectus that qualify for sale under Rule 144 of
  the Securities Act may be sold under Rule 144 rather than under this prospectus.
  107
  The Selling Stockholders
  have advised us that they have not entered into any agreements, understandings or arrangements with any underwriters or broker-dealers
  regarding the sale of their securities. There is no underwriter or coordinating broker acting in connection with the proposed sale of
  shares of Common Stock the Selling Stockholders.
  Although the shares of Common
  Stock covered by this prospectus are not currently being underwritten, the Selling Stockholders or their underwriters, brokers, dealers
  or other agents or other intermediaries, if any, that may participate with the selling security holders in any offering or distribution
  of Common Stock may be deemed "underwriters" within the meaning of the Securities Act and any profits realized or commissions
  received by them may be deemed underwriting compensation thereunder.
  Under applicable rules and
  regulations under the Exchange Act, any person engaged in a distribution of shares of the Common Stock offered hereby may not simultaneously
  engage in market making activities with respect to the Common Stock for a period of up to five days preceding such distribution. The Selling
  Stockholders will be subject to the applicable provisions of the Exchange Act and the rules and regulations promulgated thereunder, including
  without limitation Regulation M, which provisions may limit the timing of purchases and sales by the Selling Stockholders.
  In order to comply with certain
  state securities or blue sky laws and regulations, if applicable, the Common Stock offered hereby will be sold in such jurisdictions only
  through registered or licensed brokers or dealers. In certain states, the Common Stock may not be sold unless they are registered or qualified
  for sale in such state, or unless an exemption from registration or qualification is available and is obtained.
  We will bear all costs, expenses
  and fees in connection with the registration of the Common Stock offered hereby. However, the Selling Stockholders will bear any brokerage
  or underwriting commissions and similar selling expenses, if any, attributable to the sale of the shares of Common Stock offered pursuant
  to this prospectus. We have agreed to indemnify the Selling Stockholders against certain liabilities, including liabilities under the
  Securities Act, or to contribute to payments to which any of those security holders may be required to make in respect thereof.
  LEGAL MATTERS
  The validity of the securities
  being offered herein has been passed upon for us by Ellenoff Grossman & Schole LLP, New York, New York.
  EXPERTS
  The financial statements
  of Blue Water Vaccines Inc. as of and for the years ended December 31, 2021 and 2020, incorporated by reference in this registration
  statement, of which this prospectus forms a part, have been audited by Mayer Hoffman McCann P.C., independent registered public accounting
  firm, and are incorporated in reliance upon such report given on the authority of such firm as experts in auditing and accounting in giving
  said report.
  108
  DISCLOSURE OF COMMISSION POSITION ON
  INDEMNIFICATION FOR SECURITIES LAWS VIOLATIONS
  Section 145 of the DGCL inter
  alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
  pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
  such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
  as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys' fees),
  judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
  if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
  with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
  for such persons against expenses (including attorneys' fees) actually and reasonably incurred in connection with the defense or
  settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
  believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
  otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
  in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
  opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.
  Section 145 further authorizes
  a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
  or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
  against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
  not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
  directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.
  Section 102(b)(7) of the
  DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
  a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
  provision shall not eliminate or limit the liability of a director (i) for any breach of the director's duty of loyalty to the corporation
  or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
  (iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
  any transaction from which the director derived an improper personal benefit.
  Article 6 of the bylaws of
  the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
  full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
  DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
  delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
  determined that such director is not entitled to indemnification.
  109
  You should rely only on
  the information contained in this document. We have not authorized anyone to provide you with information that is different. This document
  may only be used where it is legal to sell these securities. The information in this document may only be accurate on the date of this
  document.
  Additional risks and uncertainties
  not presently known or that are currently deemed immaterial may also impair our business operations. The risks and uncertainties described
  in this document and other risks and uncertainties which we may face in the future will have a greater impact on those who purchase our
  common stock. These purchasers will purchase our common stock at the market price or at a privately negotiated price and will run the
  risk of losing their entire investment.
  BLUE WATER VACCINES INC.
  1,600,000 Shares of
  Common Stock
  PROSPECTUS
  June 24, 2022
  PART II
  INFORMATION NOT REQUIRED IN PROSPECTUS
  Item 3.
  Incorporation of Documents by Reference
  We
  are "incorporating by reference" in this prospectus certain documents we file with the Commission, which means that we can
  disclose important information to you by referring you to those documents. The information in the documents incorporated by reference
  is considered to be part of this prospectus. Statements contained in documents that we file with the Commission and that are incorporated
  by reference in this prospectus will automatically update and supersede information contained in this prospectus, including information
  in previously filed documents or reports that have been incorporated by reference in this prospectus, to the extent the new information
  differs from or is inconsistent with the old information. We have filed or may file the following documents with the Commission and they
  are incorporated herein by reference as of their respective dates of filing.
  (i)
  our Annual Report on
  Form 10-K
  for the fiscal year ended December 31, 2021 as filed with the SEC on March 31, 2022;
  (ii)
  our Quarterly Report on
  Form 10-Q
  for the quarter ended March 31, 2022 as filed with the SEC on May 13, 2022;
  (iii)
  our Current Report on
  Form
      8-K/A
  dated March 4, 2022, our Current Report on
  Form
      8-K
  dated March 22, 2022; our Current Report on
  Form
      8-K
  dated April 19, 2022; our Current Report on
  Form
      8-K
  dated April 20, 2022; our Current Report on
  Form
      8-K
  dated April 20, 2022; our Current Report on
  Form
      8-K
  dated April 21, 2022; our Current Report on
  Form
      8-K
  dated May 25, 2022; our Current Report on
  Form
      8-K
  dated June 1, 2022; and our Current Report on
  Form 8-K
  dated June 24, 2022.
  (iv)
  the description of our securities registered under Section 12 of the Exchange Act as filed as
  Exhibit 4.2
  on Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on March 31, 2022.
  All documents that we file
  with the Commission pursuant to Sections 13(a), 13(c), 14, and 15(d) of the Exchange Act subsequent to the date of this prospectus that
  indicate that all securities offered under this prospectus have been sold, or that deregisters all securities then remaining unsold, will
  be deemed to be incorporated in this prospectus by reference and to be a part hereof from the date of filing of such documents.
  Any statement contained in
  a document incorporated or deemed to be incorporated by reference in this prospectus shall be deemed modified, superseded or replaced
  for purposes of this prospectus to the extent that a statement contained in this prospectus, or in any subsequently filed document that
  also is deemed to be incorporated by reference in this prospectus, modifies, supersedes or replaces such statement. Any statement so modified,
  superseded or replaced shall not be deemed, except as so modified, superseded or replaced, to constitute a part of this prospectus. None
  of the information that we disclose under Items 2.02 or 7.01 of any Current Report on Form 8-K or any corresponding information, either
  furnished under Item 9.01 or included as an exhibit therein, that we may from time to time furnish to the Commission will be incorporated
  by reference into, or otherwise included in, this prospectus, except as otherwise expressly set forth in the relevant document. Subject
  to the foregoing, all information appearing in this prospectus is qualified in its entirety by the information appearing in the documents
  incorporated by reference.
  You may request, orally or in writing, a copy
  of these documents, which will be provided to you at no cost (other than exhibits, unless such exhibits are specifically incorporated
  by reference), by contacting Erin Henderson, c/o Blue Water Vaccines Inc., at 201 E. Fifth Street, Suite 1900, Cincinnati, OH 45202. Our
  telephone number is (513) 620-4101. Information about us is also available at our website at http://www.bluewatervaccines.com. However,
  the information on our website is not a part of this prospectus and is not incorporated by reference.
  Item 4.
  Description of Securities
  Not applicable.
  Item 5.
  Interests of Named Experts and Counsel
  Not applicable.
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  1
  Item 6.
  Indemnification of Officers and Directors
  Section 145 of the DGCL inter
  alia, empowers a Delaware corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened,
  pending or completed action, suit or proceeding (other than an action by or in the right of the corporation) by reason of the fact that
  such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation
  as a director, officer, employee or agent of another corporation or other enterprise, against expenses (including attorneys' fees),
  judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
  if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and,
  with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. Similar indemnity is authorized
  for such persons against expenses (including attorneys' fees) actually and reasonably incurred in connection with the defense or
  settlement of any such threatened, pending or completed action or suit if such person acted in good faith and in a manner he reasonably
  believed to be in or not opposed to the best interests of the corporation, and provided further that (unless a court of competent jurisdiction
  otherwise provides) such person shall not have been adjudged liable to the corporation. Any such indemnification may be made only as authorized
  in each specific case upon a determination by the stockholders or disinterested directors or by independent legal counsel in a written
  opinion that indemnification is proper because the indemnitee has met the applicable standard of conduct.
  Section 145 further authorizes
  a corporation to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation,
  or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation or enterprise,
  against any liability asserted against him and incurred by him in any such capacity, or arising out of his status as such, whether or
  not the corporation would otherwise have the power to indemnify him under Section 145. We maintain policies insuring our officers and
  directors against certain liabilities for actions taken in such capacities, including liabilities under the Securities Act.
  Section 102(b)(7) of the
  DGCL permits a corporation to include in its certificate of incorporation a provision eliminating or limiting the personal liability of
  a director to the corporation or its shareholders for monetary damages for breach of fiduciary duty as a director, provided that such
  provision shall not eliminate or limit the liability of a director (i) for any breach of the director's duty of loyalty to the corporation
  or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law,
  (iii) under Section 174 of the DGCL (relating to unlawful payment of dividends and unlawful stock purchase or redemption) or (iv) for
  any transaction from which the director derived an improper personal benefit.
  Article 6 of the bylaws of
  the Company contains provisions which are designed to provide mandatory indemnification of directors and officers of the Company to the
  full extent permitted by law, as now in effect or later amended. The bylaws further provide that, if and to the extent required by the
  DGCL, an advance payment of expenses to a director or officer of the Company that is entitled to indemnification will only be made upon
  delivery to the Company of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately
  determined that such director is not entitled to indemnification.
  Item 7.
  Exemption from Registration Claimed
  Not applicable.
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  2
  Item 8.
  Exhibits
  The following exhibits are
  filed with this Registration Statement.
  Number
  Description
  4.1
  2019 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.2
  2022 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.3
  2019 Equity Incentive Plan Form of Stock Option Grant Agreement. (Incorporated by reference to Exhibit 10.3 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.4
  2022 Equity Incentive Plan Form of Incentive Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.5
  2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Consultant). (Incorporated by reference to Exhibit 10.5 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.6
  2022 Equity Incentive Plan Form of Nonstatutory Stock Option Agreement (Non-Employee Director). (Incorporated by reference to Exhibit 10.6 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  4.7
  2022 Equity Incentive Plan Form of Nonstatuory Stock Option Agreement (Employee). (Incorporated by reference to Exhibit 10.7 to our Registration Statement on Form S-1/A, dated February 8, 2022.)
  5.1
  Opinion of Ellenoff Grossman & Schole LLP (Filed herewith)
  23.1
  Consent of Mayer Hoffman McCann P.C. (Filed herewith)
  23.2
  Consent of Ellenoff Grossman & Schole LLP (included in Exhibit 5.1)
  24
  Powers of Attorney (included on signature page)
  107
  Filing Fee Table. (Filed herwith)
  Item 9.
  Undertakings.
  (II)
  The undersigned registrant hereby undertakes:
  (II)
  To file, during any period in which offers or sales are being
  made, a post-effective amendment to this registration statement
  (II)
  To include any material information with respect to the plan
  of distribution not previously disclosed in the registration statement or any material change to such information in the registration
  statement.
  (2) That, for the purpose
  of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration
  statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
  bona fide offering thereof.
  (3) To remove from registration
  by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
  (4) That prior to any public reoffering of the
  securities registered hereunder through use of a prospectus which is a part of this registration statement, by any person or party who
  is deemed to be an underwriter within the meaning of Rule 145©, such reoffering prospectus will contain the information called for
  by the applicable registration form with respect to reofferings by persons who may be deemed underwriters, in addition to the information
  called for by the other items of the applicable form.
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  3
  (5) That every prospectus
  (i) that is filed pursuant to paragraph (4) immediately preceding, or (ii) that purports to meet the requirements of Section 10(a)(3)
  of the Securities Act of 1933 and is used in connection with an offering of securities subject to Rule 415, will be filed as a part of
  an amendment to the registration statement and will not be used until such amendment is effective, and that, for purposes of determining
  any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement
  relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide
  offering thereof.
  (6) That, for purposes of
  determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to Section 13(a)
  or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report
  pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall
  be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time
  shall be deemed to be the initial bona fide offering thereof.
  (7) To respond to requests
  for information that is incorporated by reference into the joint proxy statement/prospectus pursuant to Item 4, 10(b), 11 or 13 of this
  form, within one business day of receipt of such request, and to send the incorporated documents by first class mail or other equally
  prompt means. This includes information contained in documents filed subsequent to the effective date of the registration statement through
  the date of responding to the request.
  (8) To supply by means of
  a post-effective amendment all information concerning a transaction, and the company being acquired involved therein, that was not the
  subject of and included in the registration statement when it became effective.
  (b) Insofar as indemnification for liabilities
  arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to
  the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission
  such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a
  claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
  officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director,
  officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel
  the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
  by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
  (c) The undersigned registrant hereby undertakes
  that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report
  pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
  plan's annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the
  registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
  of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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  4
  SIGNATURES
  Pursuant to the requirements of the Securities
  Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for
  filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized,
  on June 24, 2022.
  BLUE WATER VACCINES INC.
  By:
  /s/ Joseph Hernandez
  Joseph Hernandez
  Chief Executive Officer
  II-
  5
  POWER OF ATTORNEY
  KNOW ALL MEN BY THESE PRESENTS
  , that we,
  the undersigned officers and directors of Blue Water Vaccines, Inc., a Delaware corporation, do hereby constitute and appoint Joseph Hernandez,
  as his or her true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, for him and in his name,
  place, and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and
  other documents in connection therewith) to this Registration Statement and any subsequent registration statement filed by the registrant
  pursuant to Rule 462(b) of the Securities Act of 1933, as amended, which relates to this Registration Statement, and to file the
  same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto
  said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be
  done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming
  all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
  Pursuant to the requirements of the Securities Act
  of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
  Name
  Position
  Date
  /s/ Joseph Hernandez
  Chairman of the Board and Chief Executive Officer (Principal Executive Officer)
  June 24, 2022
  Joseph Hernandez
  Chief Financial Officer (Principal Financial Officer)
  /s/ Jon Garfield
  Director
  June 24, 2022
  Jon Garfield
  /s/ Kimberly Murphy
  Director
  June 24, 2022
  Kimberly Murphy
  /s/ James Sapirstein
  Director
  June 24, 2022
  James Sapirstein
  /s/ Allan L. Shaw
  Director
  June 24, 2022
  Allan L. Shaw
  /s/ Michael Venerable
  Director
  June 24, 2022
  Michael Venerable
  II-6