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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>As filed with the Securities and Exchange Commission
  on February 1, 2024</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: right"><B>Registration No. 333-______________</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"></P>
  
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  <P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>
  
  <P STYLE="font: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></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: 14pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM S-8</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>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"><B>Onconetix, Inc.</B></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="border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center; width: 49%"><FONT STYLE="font-size: 10pt"><B>Delaware</B></FONT></TD>
      <TD STYLE="width: 2%">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center; width: 49%"><FONT STYLE="font-size: 10pt"><B>81-2262816</B></FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt">(State or Other Jurisdiction of<BR>
  Incorporation or Organization)</FONT></TD>
      <TD>&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="border-bottom: black 1.5pt solid; width: 49%">
      <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%">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; font-size: 10pt; text-align: center; width: 49%"><FONT STYLE="font-size: 10pt"><B>45202</B></FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt">(Address of Principal Executive Offices)</FONT></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt">(Zip Code)</FONT></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="border-bottom: black 1.5pt solid">
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Onconetix, Inc. 2019 Equity Incentive Plan</B></P>
      <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Onconetix, Inc. 2022 Equity Incentive Plan</B></P></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="font-size: 10pt; text-align: center"><FONT STYLE="font-size: 10pt">(Full Title of the Plan)</FONT></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"><B>Dr. Ralph Schiess</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Interim Chief Executive Officer</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Onconetix, Inc.</B></P>
  
  <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><U>Cincinnati, OH 45202</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">(Name and Address of Agent For Service)</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><U>(513) 620-4101</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Telephone Number, Including Area Code of Agent
  For Service.</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>Copy to:</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Barry I. Grossman, Esq.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Jessica Yuan, Esq.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Ellenoff Grossman &amp; Schole LLP</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>1345 Avenue of the Americas, 11th Floor</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>New York, New York 10105</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Telephone: (212) 370-1300</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; 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="text-align: justify; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">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="font-size: 10pt; width: 25%"><FONT STYLE="font-size: 10pt">Large accelerated filer</FONT></TD>
      <TD STYLE="font-size: 10pt; width: 15%"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">&#9744;</FONT></TD>
      <TD STYLE="font-size: 10pt; width: 25%">&nbsp;</TD>
      <TD STYLE="font-size: 10pt; width: 35%"><FONT STYLE="font-size: 10pt">Accelerated filer</FONT></TD>
      <TD STYLE="font-size: 10pt; width: 15%">&#9744;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="font-size: 10pt"><FONT STYLE="font-size: 10pt">Non-accelerated filer</FONT></TD>
      <TD STYLE="font-size: 10pt">&#9746;</TD>
      <TD STYLE="font-size: 10pt">&nbsp;</TD>
      <TD STYLE="font-size: 10pt"><FONT STYLE="font-size: 10pt">Smaller reporting company</FONT></TD>
      <TD STYLE="font-size: 10pt">&#9746;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD COLSPAN="2" STYLE="font-size: 10pt">&nbsp;</TD>
      <TD STYLE="font-size: 10pt">&nbsp;</TD>
      <TD STYLE="font-size: 10pt"><FONT STYLE="font-size: 10pt">Emerging growth company</FONT></TD>
      <TD STYLE="font-size: 10pt">&#9746;</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">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. &#9744;</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: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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: justify; text-indent: 0.25in">Onconetix, Inc. (the &ldquo;Registrant&rdquo;
  or the &ldquo;Company&rdquo;) is filing this registration statement on Form S-8 under the Company&rsquo;s 2019 Equity Incentive Plan (the
  &ldquo;2019 Plan&rdquo;) and the 2022 Equity Incentive Plan (the &ldquo;2022 Plan&rdquo;) to (i) register 550,000 shares of our common
  stock, par value $0.00001 per share (the &ldquo;Common Stock&rdquo;), to be issued pursuant to the 2022 Plan, as described in more detail
  herein, (ii) register for resale pursuant to a reoffer prospectus 885,796 shares of Common Stock issued to our executive officers and
  directors or to be issued to such officers and directors upon exercise of outstanding options or vesting of outstanding restricted stock
  units as described below, and (iii) serve as a post-effective amendment, pursuant to Rule 429 under the Securities Act of 1933, as amended
  (the &ldquo;Securities Act&rdquo;), to our Registration Statement on Form S-8 (File No. 333-265843) filed with the Securities and Exchange
  Commission (&ldquo;SEC&rdquo;) on June 27, 2022 as amended by the Registration Statement on Form S-8 (File No. 333-268357) filed with
  the SEC on November 14, 2022 (the &ldquo;Prior Registration Statement&rdquo;).</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; text-indent: 0.25in">Pursuant to General Instruction
  E to Form S-8, the contents of the Prior Registration Statement is incorporated herein by reference, except to the extent supplemented,
  amended or superseded by the information set forth in this registration statement on Form S-8.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">This Registration Statement
  includes, pursuant to General Instruction E to Form S-8, a re-offer prospectus in Part I (the &ldquo;Reoffer Prospectus&rdquo;). The Reoffer
  Prospectus may be utilized for reofferings and resales by certain executive officers and directors listed in the Reoffer Prospectus who
  may be deemed &ldquo;affiliates&rdquo; of the Company on a continuous or a delayed basis in the future of up to 885,796 Common Shares
  issued or to be issued under the 2019 and the 2022 Plan. These shares constitute &ldquo;control securities&rdquo; or &ldquo;restricted
  securities&rdquo; which have been issued prior to or issuable after the filing of this Registration Statement. The Reoffer Prospectus
  does not contain all of the information included in the Registration Statement, certain items of which are contained in schedules and
  exhibits to the Registration Statement, as permitted by the rules and regulations of the SEC. Statements contained in the Reoffer Prospectus
  as to the contents of any agreement, instrument or other document referred to are not necessarily complete. With respect to each such
  agreement, instrument or other document filed as an exhibit to the Registration Statement, we refer you to the exhibit for a more complete
  description of the matter involved, and each such statement shall be deemed qualified in its entirety by this reference.</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; 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 144(e) of the Securities Act.</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-top: 0pt; margin-bottom: 0pt; text-align: center"><B>PART I</B></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>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: justify"><B>Item 1. Plan Information.*</B></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>Item 2. Registrant Information and Employee
  Plan Annual Information.*</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B></B>&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>
  
  <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: 0in"></TD><TD STYLE="width: 0.25in; text-align: left">*</TD><TD STYLE="text-align: justify">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 of 1934, as amended (the &ldquo;Securities Act&rdquo;). 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.</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"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>REOFFER 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-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B>Onconetix, Inc.</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: justify; background-color: white"><B>Up to 885,796 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: justify; text-indent: 0.25in; background-color: white">This
  prospectus relates to the resale of up to 885,796 shares (the &ldquo;Shares&rdquo;) of common stock, par value $0.00001 per share (the
  &ldquo;Common Stock&rdquo;), of Onconetix, 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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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 40 of this prospectus.
  Our Common Stock is listed on The Nasdaq Capital Market under the symbol &ldquo;ONCO.&rdquo; On January 30, 2024, the closing price of
  the Common Stock on The Nasdaq Capital Market was $0.207 per share.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">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
  $0.146 on January 24, 2024 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 various announcements regarding certain
  research developments, agreements, acquisitions, a shift in business strategy to focus on oncology, changes in management and other matters.
  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 33 of this prospectus.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">SEE
  &ldquo;RISK FACTORS&rdquo; BEGINNING ON PAGE 33 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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white">The date of this prospectus
  is February 1, 2024.</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: 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"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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="width: 1%">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: center; width: 9%"><FONT STYLE="font-size: 10pt"><B>Page No</B></FONT></TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><A HREF="#b_001"><FONT STYLE="font-size: 10pt">Where You Can Find More Information</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">ii</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: justify"><A HREF="#b_002"><FONT STYLE="font-size: 10pt">Prospectus Summary</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">1</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><A HREF="#b_003"><FONT STYLE="font-size: 10pt">Incorporation of Certain Documents By Reference</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">II-1</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: justify"><A HREF="#b_004"><FONT STYLE="font-size: 10pt">Note on Forward Looking Statements</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">15</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">The Company</FONT></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: justify"><A HREF="#b_005"><FONT STYLE="font-size: 10pt">Risk Factors</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">34</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><A HREF="#b_006"><FONT STYLE="font-size: 10pt">Selling Stockholders</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">41</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: justify"><A HREF="#b_007"><FONT STYLE="font-size: 10pt">Use of Proceeds</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">42</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><A HREF="#b_008"><FONT STYLE="font-size: 10pt">Plan of Distribution</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">42</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: justify"><A HREF="#b_009"><FONT STYLE="font-size: 10pt">Legal Matters</FONT></A></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">43</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Experts</FONT></TD>
      <TD>&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</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: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B><A NAME="b_001"></A>WHERE YOU CAN FIND
  MORE INFORMATION</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: justify; 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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">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; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"></P>
  
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><A NAME="b_002"></A><B>PROSPECTUS SUMMARY</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white"><I>The
  Commission allows us to &ldquo;incorporate by reference&rdquo; certain information that we file with the Commission, which means that
  we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered
  to be part of this prospectus, and information that we file later with the Commission will update automatically, supplement and/or supersede
  the information disclosed in this prospectus. Any statement contained in a document incorporated or deemed to be incorporated by reference
  in this prospectus shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained
  in this prospectus or in any other document that also is or is deemed to be incorporated by reference in this prospectus modifies or supersedes
  such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a
  part of this prospectus. You should read the following summary together with the more detailed information regarding our company, our
  Common Stock and our financial statements and notes to those statements incorporated herein by reference.</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B>Our Company</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">We are a commercial stage biotechnology company
  focused on the research, development, and commercialization of innovative solutions for oncology. We own ENTADFI, an FDA-approved, once
  daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (&ldquo;BPH&rdquo;), a disorder of
  the prostate, and Proclarix, a European CE IVD approval for prostate diagnostics and a lab developed test currently in the U.S., originally
  developed by Proteomedix.</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; text-indent: 0.25in; text-align: justify">ENTADFI allows men to receive treatment for their
  symptoms of BPH without the negative sexual side effects typically seen in patients on finasteride alone. Following a recent business
  strategy shift towards the field of oncology and deprioritization of preclinical vaccine programs, we are building additional assets in
  therapeutics, diagnostics, and clinician services for oncology. ENTADFI will become the inaugural therapeutic drug in the Company&rsquo;s
  expanding portfolio of oncology therapeutics once launched.&nbsp;</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; text-indent: 0.25in; text-align: justify">Proclarix is an easy-to-use next generation protein-based
  blood test that can be done with the same sample as a patient&rsquo;s regular Prostate-Specific Antigen (&ldquo;PSA&rdquo;) test. The
  PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level
  of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate
  stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians. It is
  estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment
  that impacts the physician&rsquo;s routine, our healthcare system, and the quality of patients&rsquo; lives. Proclarix helps doctors and
  patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic
  support for further treatment decisions. No additional intervention is required and results are available quickly. Local diagnostic laboratories
  can easily add this affordable multiparametric test to their existing infrastructure.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Prior to the acquisition of ENTADFI, we managed one distinct business
  segment, which was research and development. Beginning in the second quarter of 2023, as a result of the acquisition of ENTADFI, for which
  we are working towards commercial launch, we operated in two business segments: research and development and commercial. During the third
  quarter of 2023, we deprioritized our vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial.
  Our recent acquisition of Proteomedix during the fourth quarter of 2023 and its related diagnostic product Proclarix was determined to
  be within our commercial segment. The research and development segment was our historical business, and was dedicated to the research
  and development of various vaccines to prevent infectious diseases. The commercial segment was new in the second quarter of 2023 and is
  dedicated to the commercialization of our FDA-approved products, namely ENTADFI and Proclarix.</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>
  
  </DIV>
  
  <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"></P>
  
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify">Recent key developments affecting our business
  include:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Announced Shift in Business Strategy to Focus on the Field of Oncology:</I></B>&nbsp;On October 30, 2023, in a letter to shareholders, former President and CEO, Dr. Neil Campbell, announced that the Company intends to shift its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of oncology. The Company&rsquo;s previous activities in acquiring assets from WraSer and Xspire Pharma, including certain commercial relationships intended for the marketing and sale of these assets, were reassessed and it was decided that they would not align with the new shift towards oncology. Additionally, the Company conducted a strategic and tactical assessment of its preclinical vaccine programs and, considering the immense amount of time and resources needed to pursue these programs as well as evolving market dynamics, these programs have been deprioritized. The Company believes that the strategic shift in business strategy towards the field of oncology, as well as pursuing the launch of ENTADFI&nbsp;in 2024, will enhance shareholder value and enable the Company to provide leading-edge therapeutics, diagnostics, and services to clinicians, patients, and caregivers.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Acquired a Commercial Stage Oncology Company:</I></B>&nbsp;On December 15, 2023, the Company closed its acquisition of Proteomedix AG, a private, commercial-stage diagnostics oncology company (&ldquo;Proteomedix&rdquo;), and introduced Onconetix, Inc. as a new name for the combined Company. The closing of the acquisition of Proteomedix for all stock consideration (the &ldquo;Closing&rdquo;) provides Proteomedix shareholders with an initial 19.9% ownership stake of Onconetix, and Series B preferred stock convertible into 269,672,900 additional common shares of Onconetix subject to Onconetix shareholder approval of the same.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Signed Various Agreements to Support the Commercial Launch of ENTADFI:</I></B>&nbsp;Throughout the third quarter of 2023, the Company signed several agreements and established key relationships to support the commercial launch of ENTADFI. These agreements include the following:</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Marketing and Advertising Support:</I></B>&nbsp;In July 2023, the Company signed a Master Services Agreement with bfw Advertising Inc. (&ldquo;bfw&rdquo;) to generate marketing and advertising material for Onconetix&rsquo;s commercial stage drug portfolio. Bfw will work with Onconetix&rsquo;s commercial team to increase awareness for its commercial products through patient-facing materials, website updates, social ads, targeted provider engagement, as well as materials to support Onconetix&rsquo;s sales team, among other services.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Healthcare Payer Coverage Support:</I></B>&nbsp;In July 2023, Onconetix signed an agreement with Advantage Point Solutions, LLC (&ldquo;APS&rdquo;) to support Onconetix&rsquo;s market access strategy for its commercial pharmaceutical portfolio. APS will support market access for ENTADFI, including assistance in formulary negotiations with key healthcare payers and pharmacy benefit managers in the commercial and government sectors. With its robust network of relationships, APS helps commercial stage pharmaceutical companies build long-term relationships with payers with the goal of maximizing access and reimbursement for approved pharmaceutical products. APS also has decades of experience advising companies on product launches across a broad spectrum of therapeutic areas.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
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    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Telemedicine Channel:</I></B>&nbsp;In July 2023, Onconetix signed an agreement with UpScriptHealth to generate a robust, online telemedicine platform to distribute ENTADFI. Through this platform, UpScriptHealth will help support patients with benign prostatic hyperplasia throughout the prescription and coverage process, as well as provide eligible patients access to ENTADFI<SUP>&nbsp;</SUP>mailed directly to their homes.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Entered into Distribution Agreement</I></B>: On September 21, 2023, the Company entered into an Exclusive Distribution Agreement to engage Cardinal Health 105, LLC as its exclusive third-party logistics distribution agent for sales of all of the Company&rsquo;s commercial assets.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B><I>Granted Pharmaceutical Wholesaler License in Ohio and Tennessee:</I></B>&nbsp;The Ohio State Board of Pharmacy and the Tennessee State Board of Pharmacy, in July 2023 and September 2023, respectively, granted Onconetix a license to operate as a pharmaceutical wholesaler. These licenses allow Onconetix to conduct business in the States of Ohio and Tennessee.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">Since our inception in October 2018 until April
  2023, when we acquired ENTADFI, we 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, acquiring and developing
  our technology and now deprioritized vaccine candidates, organizing and staffing our company, performing business planning, establishing
  our intellectual property portfolio and raising capital to support and expand such activities.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">We are currently focusing our efforts on (i) building
  out our commercial capabilities to launch ENTADFI&nbsp;in the marketplace and (ii) commercializing Proclarix.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 8; Value: 1 -->
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify">Given ENTADFI&nbsp;and Proclarix are currently
  FDA-approved, we expect to generate revenue from sales of ENTADFI&nbsp;and Proclarix in the near term. Although we anticipate these sales
  to offset some expenses relating to commercial scale up and development, we expect our expenses will increase substantially in connection
  with our ongoing activities, as we:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">Commercialize and/</FONT>or <FONT STYLE="font-size: 10pt">launch ENTADFI and Proclarix, and other commercial-stage products,</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">hire additional personnel;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">operate as a public company, and;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
    <TR STYLE="vertical-align: top">
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="padding-right: 0.8pt; text-align: justify"><FONT STYLE="font-size: 10pt">obtain, maintain, expand and protect our intellectual property portfolio.</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; text-indent: 0.25in; text-align: justify">We rely and will continue to rely on third parties
  for the manufacturing of ENTADFI and Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third
  parties, of which the main suppliers are single-source suppliers, for commercial products.</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; text-indent: 0.25in; text-align: justify">As we have a product in commercial stage, we are
  seeking to build a robust and efficient commercial team to accommodate this development. This includes appropriate personnel and third-party
  relationships and contracts to execute our commercialization strategy. We also expect to incur significant commercialization expenses
  related to marketing, manufacturing and distribution for those products.</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; text-indent: 0.25in; text-align: justify">We do not have any products approved for sale,
  aside from ENTADFI, which we have not generated any revenue from product sales from, and Proclarix, which we have generated only minimal
  amounts of revenue from since its acquisition. To date, we have financed our operations primarily with proceeds from our sale of preferred
  securities to seed investors, the close of the IPO, the close of the 2022 Private Placements, the proceeds received from a warrant exercise
  in August 2023, and the proceeds received from the issuance of debt in January 2024. We will continue to require significant additional
  capital to commercialize ENTADFI&nbsp;and Proclarix and fund operations for the foreseeable future. Accordingly, until such time as we
  can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party
  (including government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations,
  strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations.</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; text-indent: 0.25in; text-align: justify">We have incurred net losses since inception and
  expect to continue to incur net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and
  year-to-year, depending in large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures
  on other research and development activities and commercialization activities. As of September 30, 2023, the Company had a working capital
  deficit of approximately $8.1 million and an accumulated deficit of approximately $34.4 million. We will need to raise additional capital
  within the next 12 months to sustain operations. In addition, if Stockholder Approval is not obtained by January 1,
  2025, the Company may be obligated to cash settle the Series B Convertible Preferred Stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Until we generate revenue
  sufficient to support self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued
  operations, including our product development and commercialization activities related to our current and future products. There can
  be no assurance that additional capital will be available to us on acceptable terms, or at all, or that we will ever generate
  revenue sufficient to provide for self-sustaining cash flows. These circumstances raise substantial doubt about our ability to
  continue as a going concern. The September 30, 2023 condensed financial statements incorporated by reference in this Registration
  Statement do not include any adjustment that might be necessary if the Company is unable to continue as a going concern.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Because of the numerous risks and uncertainties
  associated with our business, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve
  or maintain profitability. Additionally, even if we are able to generate revenue from ENTADFI or Proclarix, we may not become profitable.
  If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations
  at planned levels and may be forced to reduce our operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Management and Board Changes</B></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; text-indent: 0.25in; text-align: justify">Effective as of August 16, 2023, Joseph Hernandez
  resigned as Chairman, Chief Executive Officer, and a member of the Board of Directors (the &ldquo;Board&rdquo;) of the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Effective August 16, 2023, the Board appointed
  Jon Garfield, the Company&rsquo;s former Chief Financial Officer, to serve as the Company&rsquo;s interim principal executive officer.
  Effective as of October 4, 2023, Jon Garfield resigned as Chief Financial Officer and interim principal executive officer of the Company.
  The Company and Mr. Garfield entered into a separation agreement, which provided for two months of severance payment.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Effective as of September 2, 2023, Vuk Jeremic
  resigned as a member of the Board of the Company as well as from his positions as a member of the Compensation Committee and Nominating
  and Corporate Governance Committee of the Board. Mr. Jeremic&rsquo;s departure was not the result of any disagreement with management
  or the Board on any matter relating to the Company&rsquo;s operations, policies or practices.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On October 4, 2023 (the &ldquo;Effective Date&rdquo;),
  the Company appointed Dr. Neil Campbell, 63, as President and Chief Executive Officer of the Company and as a member of the Board of Directors
  (the &ldquo;Board&rdquo;) of the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">In connection with Dr.
  Campbell&rsquo;s appointment, the Company and Dr. Campbell entered into an employment agreement (the &ldquo;Campbell Employment
  Agreement&rdquo;), pursuant to which Dr. Campbell&nbsp;would serve as President and Chief Executive Officer of the Company and was
  paid a signing bonus of $75,000 and an annual base salary of $475,000. Pursuant to the Campbell Employment Agreement, Dr.
  Campbell&nbsp;was granted a long-term equity incentive grant in the form of an option to purchase 532,326 shares of the
  Company&rsquo;s common stock. Such award was to vest in quarterly increments over a period of three years, subject to Dr.
  Campbell&rsquo;s continued employment by the Company on the applicable vesting date. Dr. Campbell&rsquo;s option grant has an
  exercise price per share equal to $0.4305, which was the closing price of the Company&rsquo;s common stock on Nasdaq on the grant
  date.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On October 4, 2023, the Company also appointed
  Bruce Harmon, 65, as Chief Financial Officer of the Company, effective immediately.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">In connection with Mr. Harmon&rsquo;s appointment,
  the Company and Mr. Harmon entered into an employment agreement (the &ldquo;Harmon Employment Agreement&rdquo;), pursuant to which Mr.&nbsp;Harmon&nbsp;will
  serve as Chief Financial Officer of the Company and will be paid an annual base salary of $325,000. In addition, Mr.&nbsp;Harmon&nbsp;is
  entitled to receive, subject to employment by the Company on the applicable date of bonus payout, an annual target discretionary bonus
  of up to 30% of his annual base salary, payable at the discretion of the Compensation Committee of the Board. Pursuant to the Harmon Employment
  Agreement, Mr.&nbsp;Harmon&nbsp;is also eligible to receive healthcare benefits as may be provided from time to time by the Company to
  its employees generally, and to receive paid time off annually. Pursuant to the Harmon Employment Agreement, Mr.&nbsp;Harmon&nbsp;was
  granted a long-term equity incentive grant in the form of an option to purchase 177,442 shares of the Company&rsquo;s common stock. Such
  award vests in quarterly increments over a period of three years, subject to Mr.&nbsp;Harmon&rsquo;s continued employment by the Company
  on the applicable vesting date. Mr.&nbsp;Harmon&rsquo;s option grant has an exercise price per share equal to $0.4305, which was the closing
  price of the Company&rsquo;s common stock on Nasdaq on the grant date.</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; text-indent: 0.25in; text-align: justify">In connection with the acquisition of Proteomedix,
  Christian Br&uuml;hlmann was appointed as Chief Strategy Officer and Dr. Ralph Schiess was appointed as Chief Science Officer. Mr. Br&uuml;hlmann
  co-founded Proteomedix and served as its Chief Financial and Operations Officer from March 2010 until November 2018. Beginning in December
  2018, Mr. Br&uuml;hlmann served as Proteomedix&rsquo;s Chief Business Officer until the consummation of the Closing. Dr. Schiess co-founded
  Proteomedix in March 2010 and served as its Chief Executive Officer from its inception until December 2019. Dr. Schiess then served as
  Proteomedix&rsquo;s Chief Scientific Officer from January 2020 to May 2023. Dr. Schiess returned to his role as Chief Executive Officer
  in June 2023 and served until the consummation of the Closing.</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-indent: 0.25in; text-align: justify">On and effective December 21, 2023, Erin Henderson
  resigned as Chief Business Officer to pursue other opportunities. On January 17, 2024, the Company entered into a Separation Agreement
  and General Release with Ms. Henderson, pursuant to which the Company agreed to engage The Aetos Group, a management consulting company
  founded and managed by Ms. Henderson (&ldquo;Aetos&rdquo;), to perform certain consulting services for the Company. On January 17, 2024,
  the Company entered into a Consulting Agreement with Aetos, pursuant to which Aetos will provide consulting services to the Company until
  April 25, 2024 and receive a monthly fee of approximately $27,083.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify">On and effective January 10, 2024, Dr. Neil Campbell
  resigned as Chief Executive Officer, President and Director. The Company entered into a Release of Claims with Dr. Campbell, pursuant
  to which Dr. Campbell will receive a one-time severance payment of $158,333.&nbsp;On January 12, 2024, the Board appointed Dr. Ralph Schiess,
  the Company&rsquo;s Chief Science Officer, to serve as the Company&rsquo;s Interim Chief Executive Officer. As Interim Chief Executive
  Officer, Dr. Schiess shall have general supervision and direction of the business and affairs of the Company.&nbsp;</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>Recent Acquisitions:</B></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>Proteomedix</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On December 15, 2023, Onconetix entered into a
  Share Exchange Agreement (the &ldquo;Share Exchange Agreement&rdquo;), by and among (i) Onconetix, (ii) Proteomedix (iii) each of the
  holders of outstanding capital stock or Proteomedix Convertible Securities (other than Proteomedix Stock Options) named therein (collectively,
  the &ldquo;Sellers&rdquo;) and (iv) Thomas Meier, in the capacity as the representative of Sellers in accordance with the terms and conditions
  of the Share Exchange Agreement (the &ldquo;Sellers&rsquo; Representative&rdquo;).</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; text-indent: 0.25in; text-align: justify">Pursuant to the Share Exchange Agreement,
  subject to the terms and conditions set forth therein,&nbsp;the Sellers agreed to sell to Onconetix, and Onconetix agreed to buy, all
  of the issued and outstanding equity interests of Proteomedix (the &ldquo;Purchased Shares&rdquo;) in exchange for newly issued shares
  of common stock of Onconetix, par value $0.00001 per share (&ldquo;Buyer Common Stock&rdquo;), and newly issued shares of preferred stock
  of Onconetix, par value $0.00001 per share (&ldquo;Series B Convertible Preferred Stock&rdquo;), as further described below (the &ldquo;Share
  Exchange&rdquo; and the other transactions contemplated by the Share Exchange Agreement, the &ldquo;Transactions&rdquo;).</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; text-indent: 0.25in; text-align: justify">The consummation (the &ldquo;Closing&rdquo;)
  of the Share Exchange was subject to customary closing conditions and the execution of the Subscription Agreement (as defined below) entered
  into with an investor (the &ldquo;Investor&rdquo;).&nbsp;The Share Exchange closed on December 15, 2023 (the &ldquo;Closing Date&rdquo;).&nbsp;</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"><I>Consideration</I></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; text-indent: 0.25in; text-align: justify">In full payment for the Purchased Shares, Onconetix
  issued shares (the &ldquo;Exchange Shares&rdquo;) consisting of: (i) 3,675,414 shares of Buyer Common Stock equal to approximately 19.9%
  of the total issued and outstanding Buyer Common Stock and (ii) 2,696,729 shares of Series B Convertible Preferred Stock convertible into
  269,672,900 shares of Buyer Common Stock. The aggregate value of the Exchange Shares at Closing was equal to approximately Seventy-Five
  Million U.S. Dollars ($75,000,000) (the &ldquo;Exchange Consideration&rdquo;) less the value of the Proteomedix Shares for which the Proteomedix
  Stock Options are exercisable immediately prior to the Closing, subject to adjustment for indemnification as described below.</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; text-indent: 0.25in; text-align: justify">Tungsten Advisors acted as financial advisor to
  Proteomedix. As part of compensation for services rendered by Tungsten Advisors, $7,500,000 in Exchange Shares was issued to certain affiliates
  of Tungsten Advisors (the &ldquo;Advisor Parties&rdquo;) out of the total Exchange Consideration issued by Onconetix.</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; text-indent: 0.25in; text-align: justify">As a result of the Transactions, Proteomedix became
  a direct, wholly-owned subsidiary of Onconetix. It is anticipated that, following the Conversion (as defined below) and closing of the
  investment pursuant to the Subscription Agreement (as defined below), Sellers will own 79.8% of the outstanding equity interests of Onconetix,
  the Investor will own 5.9% of the outstanding equity interests of Onconetix, and the stockholders of Buyer immediately prior to the Closing
  will own 5.4% of the outstanding equity interests of Onconetix.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify">Each option to purchase shares of Proteomedix
  (each, a &ldquo;Proteomedix Stock Option&rdquo;) outstanding immediately before the Closing, whether vested or unvested, remains outstanding
  until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion, each outstanding Proteomedix Stock Option,
  whether vested unvested, shall be assumed by Onconetix and converted into the right to receive (a) an option to acquire shares of Buyer
  Common Stock (each, an &ldquo;Assumed Option&rdquo;) or (b) such other derivative security as Onconetix and Proteomedix may agree, subject
  in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock Option immediately before the
  Closing. Each Assumed Option shall: (i) represent the right to acquire a number of shares of Buyer Common Stock equal to the product of
  (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix Option immediately prior to the Closing,
  multiplied by (B) the Exchange Ratio; and (ii) have an exercise price (as rounded down to the nearest whole cent) equal to the quotient
  of (A) the exercise price of the corresponding Proteomedix Option, divided by (B) the Exchange Ratio.</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; text-indent: 0.25in; text-align: justify"><I>Indemnification</I>. Until the earlier of (i)
  Stockholder Approval or (ii) June 30, 2024 (the &ldquo;Claim Deadline&rdquo;), Onconetix may assert Claims against Proteomedix and Sellers
  for any and all Losses incurred by Onconetix with respect to: (i) any inaccuracy in or breach of any of the representations or warranties
  made by Proteomedix contained in the Share Exchange Agreement or (ii) any breach or non-fulfillment of any covenant, agreement or obligation
  to be performed by Proteomedix pursuant to the Share Exchange Agreement. Until the Claim Deadline, the Sellers&rsquo; Representative,
  acting on behalf of the Sellers, may assert Claims against Onconetix for any Loss incurred by the Sellers with respect to: (i) any inaccuracy
  in or breach of any of the representations or warranties of Onconetix contained in the Share Exchange Agreement or (ii) any breach or
  non-fulfillment of any covenant, agreement or obligation to be performed by Onconetix pursuant to the Share Exchange Agreement.</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; text-indent: 0.25in; text-align: justify">The number of shares of Buyer Common Stock issued
  upon Conversion shall be increased or decreased by a number determined by dividing the Net Adjustment by the ten-day volume-weighted average
  price (&ldquo;VWAP&rdquo;) of the Buyer Common Stock for the ten (10)-day period preceding the third day prior to the Closing Date and
  rounding down to the nearest whole share; provided, however, that (i) there shall be no adjustment to the number of shares of Buyer Common
  Stock issued upon Conversion if the Net Adjustment is less than $1,000,000 and (ii) the number of shares of Buyer Common Stock issued
  upon Conversion shall not be increased or decreased by more than 10% of the number of shares of Buyer Common Stock that would be issuable
  absent such adjustment. As used herein, &ldquo;Net Adjustment&rdquo; means the absolute value of the difference between the aggregate
  adjustment in favor of each party with respect to Losses that is agreed by Buyer and the Sellers&rsquo; Representative or determined by
  a mutually acceptable dispute resolution firm.</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; text-indent: 0.25in; text-align: justify">From and after the Closing and until the first
  anniversary of the Closing, Sellers, severally and not jointly, are required to indemnify Onconetix and its affiliates and their respective
  representatives (collectively, the &ldquo;Buyer Indemnitees&rdquo;) against (i) any inaccuracy in or breach of any of the representations
  or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach or non-fulfillment of any covenant, agreement or
  obligation to be performed by such Seller pursuant to the Share Exchange Agreement. Any payment due from any Seller in respect of an indemnification
  claim by any Buyer Indemnitee shall solely be satisfied by recourse to the Exchange Shares and the shares of Buyer Common Stock issuable
  upon the Conversion, with each share of Buyer Common Stock valued at the same price per share of Buyer Common Stock used to determine
  the Exchange Ratio.&nbsp;</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"><I>Shareholder Approval</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">The issuance of the Conversion Shares, amendment
  of Onconetix&rsquo;s certificate of incorporation to authorize sufficient additional shares of Buyer Common Stock to permit the Conversion
  and the appointment of certain individuals to the Board requires the approval of Onconetix&rsquo;s stockholders. Onconetix agreed to prepare
  and file with the Securities and Exchange Commission (&ldquo;SEC&rdquo;) a proxy statement (a &ldquo;Proxy Statement&rdquo;) for the purpose
  of soliciting proxies from the stockholders of Onconetix for the matters to be acted on at the special meeting of the stockholders of
  Onconetix. Onconetix also agreed to prepare a registration statement on Form S-1 or Form S-4 in connection with the registration under
  the Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), of the issuance of Buyer Securities to be issued under the
  Share Exchange Agreement and containing a Proxy Statement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 12; Value: 1 -->
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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"><I>Series B Convertible Preferred Stock&nbsp;</I></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; text-indent: 0.25in; text-align: justify">Upon Stockholder Approval, each share of Series
  B Convertible Preferred Stock shall automatically convert into 100 shares of Buyer Common Stock in accordance with the terms of the Certificate
  of Designation (the &ldquo;Conversion&rdquo;), a copy of which is attached hereto as Exhibit 4.1. If Stockholder Approval is not obtained
  by January 1, 2025, Onconetix shall be obligated to cash settle the Series B Convertible Preferred Stock, as described below. The terms
  of the&nbsp;Series B Convertible Preferred Stock, as described in the Certificate of Designation,&nbsp;are as follows:</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; text-indent: 0.25in; text-align: justify"><I>Voting</I>.&nbsp;The shares of&nbsp;Series
  B Convertible Preferred Stock&nbsp;carry no voting rights except: (i) with respect to the election of the Proteomedix Director (as described
  below) and (ii) that&nbsp;the affirmative vote of the holders of a majority of the outstanding shares of&nbsp;Series B Convertible Preferred
  Stock&nbsp;(the &ldquo;Majority Holders&rdquo;), acting as a single class, shall be necessary to (A) alter or change adversely the powers,
  preferences or rights given to the Series B Convertible Preferred Stock, (B) alter or amend the Certificate of Designation, or amend or
  repeal any provision of, or add any provision to, Onconetix&rsquo;s certificate of incorporation or bylaws, if such action would adversely
  alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the&nbsp;Series B Convertible&nbsp;Preferred
  Stock, (C) issue further shares of Series B Convertible Preferred Stock or increase or decrease (other than by conversion) the number
  of authorized shares of Series B Convertible Preferred Stock, or (D) authorize or create any class or series of stock, or issue shares
  of any class or series of stock, that has powers, preferences or rights senior to the Series B Convertible Preferred Stock</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; text-indent: 0.25in; text-align: justify"><I>Proteomedix Director</I>.&nbsp;The Majority
  Holders, voting exclusively and as a separate class, shall be entitled to elect one (1) director of Onconetix. Any director elected as
  provided in the preceding sentence may be removed without cause by, and only by, the affirmative vote of the holders of the Series B Convertible
  Preferred Stock. If the holders of Series B Convertible Preferred Stock fail to elect a director, then any directorship not so filled
  shall remain vacant until such time as the holders of the Series B Convertible Preferred Stock elect a person to fill such directorship;
  and no such directorship may be filled by stockholders of Onconetix other than by the holders of Series B Convertible Preferred Stock.
  At any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the outstanding
  shares of Series B Convertible Preferred Stock shall constitute a quorum for the purpose of electing such director.</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; text-indent: 0.25in; text-align: justify"><I>Redemption</I>. The shares of Series B Convertible
  Preferred Stock are not redeemable by Onconetix.</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; text-indent: 0.25in; text-align: justify"><I>Liquidation Preference.</I>&nbsp;Upon a liquidation,
  dissolution or winding-up of Onconetix, whether voluntary or involuntary (a &ldquo;Liquidation&rdquo;), the holders of Series B Convertible
  Preferred Stock shall be entitled to receive out of the assets, whether capital or surplus, of Onconetix the same amount that a holder
  of Buyer Common Stock would receive if such Holder&rsquo;s Series B Convertible Preferred Stock were fully converted to Buyer Common Stock
  at the Conversion Ratio (as defined below) plus an additional amount equal to any dividends declared but unpaid to such shares, which
  amounts shall be paid&nbsp;<I>pari passu </I>with all holders of Buyer Common Stock.</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; text-indent: 0.25in; text-align: justify"><I>Dividends</I>. The holders of the Series B
  Convertible Preferred Stock shall be entitled to receive, dividends on shares of Series B Convertible Preferred Stock (on an as-if-converted-to-common-stock
  basis) equal to and in the same form, and in the same manner, as dividends (other than dividends on shares of the Buyer Common Stock payable
  in the form of Buyer Common Stock) actually paid on shares of the Buyer Common Stock when, as and if such dividends (other than dividends
  payable in the form of Buyer Common Stock) are paid on shares of the Buyer Common Stock.</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; text-indent: 0.25in; text-align: justify"><I>Conversion. </I>Following Stockholder Approval,
  each share of Series B Convertible Preferred Stock shall be converted into shares of Buyer Common Stock (the &ldquo;Conversion Shares&rdquo;)
  at a ratio of 100 Conversion Shares for each share of Series B Convertible Preferred Stock (the &ldquo;Conversion Ratio&rdquo;). All shares
  of Series B Convertible Preferred Stock shall automatically and without any further action required be converted into Conversion Shares
  at the Conversion Ratio upon the latest date on which (i) Onconetix has received the Stockholder Approval with respect to the issuance
  of all of the shares of Buyer Common Stock issuable upon Conversion in excess of 20% of the issued and outstanding Buyer Common Stock
  on the Closing Date and (ii) Onconetix has effected an increase in the number of shares of Buyer Common Stock authorized under its certificate
  of incorporation, to the extent required to consummate the Transactions.&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 13; Value: 1 -->
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify"><I>Cash Settlement</I>. If, at any time after
  the earlier of the date of the Stockholder Approval or January 1, 2025 (the earliest such date, the &ldquo;Cash Settlement Date&rdquo;),
  Onconetix (x)&nbsp;has obtained the Stockholder Approval but fails to or has failed to deliver to a holder certificate or certificates
  representing the Conversion Shares, or deliver documentation of book entry form of (or cause its transfer agent to electronically deliver
  such evidence) Conversion Shares on or prior to the fifth business day after the date of the Stockholder Approval, or (y)&nbsp;has failed
  to obtain the Stockholder Approval, Onconetix shall, in either case, at the request of the holder setting forth such holder&rsquo;s request
  to cash settle a number of shares of Series B Convertible Preferred Stock, pay to such holder an amount in cash equal to (i) the Fair
  Value (as defined below) of the shares of Series B Convertible Preferred Stock set forth in such request multiplied by (ii) the Conversion
  Ratio in effect on the trading day on which the request is delivered to Onconetix, with such payment to be made within two (2) business
  days from the date of the request by the holder, whereupon, after payment in full thereon by Onconetix, Onconetix&rsquo;s obligations
  to deliver such shares underlying the request shall be extinguished. &ldquo;Fair Value&rdquo; of shares shall be fixed with reference
  to the last reported closing stock price on the principal trading market of the Buyer Common Stock on which the Buyer Common Stock is
  listed as of the trading day on which the request is delivered to Onconetix.</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; text-indent: 0.25in; text-align: justify"><I>Certain Adjustments</I>. If Onconetix,
  at any time while the&nbsp;Series B Convertible Preferred Stock is outstanding: (A)&nbsp;pays a stock dividend or otherwise makes a distribution
  or distributions payable in shares of Buyer Common Stock; (B) subdivides outstanding shares of Buyer Common Stock into a larger number
  of shares; or (C) combines (including by way of a reverse stock split) outstanding shares of Buyer Common Stock into a smaller number
  of shares, then the Conversion Ratio shall be multiplied by a fraction of which the numerator shall be the number of shares of Buyer Common
  Stock outstanding immediately after such event and of which the denominator shall be the number of shares of Buyer Common Stock outstanding
  immediately before such event (excluding any treasury shares of the Corporation). If, at any time while the&nbsp;Series B Convertible
  Preferred Stock is outstanding, either (A) Onconetix effects any merger or consolidation of Onconetix with or into another person or any
  stock sale to, or other business combination with or into another person (other than such a transaction in which Onconetix is the surviving
  or continuing entity and holds at least a majority of the Buyer Common Stock after giving effect to the transaction and its Buyer Common
  Stock is not exchanged for or converted into other securities, cash or property), (B) Onconetix effects any sale, lease, transfer or exclusive
  license of all or substantially all of its assets in one transaction or a series of related transactions, (C)&nbsp;any tender offer or
  exchange offer (whether by Onconetix or another person) is completed pursuant to which more than 50% of the Buyer Common Stock not held
  by Onconetix or such person is exchanged for or converted into other securities, cash or property, or (D)&nbsp;Onconetix effects any reclassification
  of the Buyer Common Stock or any compulsory share exchange pursuant to which the Buyer Common Stock is effectively converted into or exchanged
  for other securities, cash or property (in any such case, a &ldquo;Fundamental Transaction&rdquo;), then, in connection with such Fundamental
  Transaction, the holders of Series B Convertible Preferred Stock shall receive in the Fundamental Transaction, the same kind and amount
  of securities, cash or property that a holder of Buyer Common Stock would receive if such holder&rsquo;s Series B Convertible Preferred
  Stock were fully converted to Buyer Common Stock, plus an additional amount equal to any dividends declared but unpaid to such shares,
  which amounts shall be paid&nbsp;pari passu&nbsp;with all holders of Buyer Common Stock in the Fundamental Transaction (the &ldquo;Alternate
  Consideration&rdquo;). If holders of Buyer Common Stock are given any choice as to the securities, cash or&nbsp;property to be received
  in a Fundamental Transaction, then the holders of Series B Convertible Preferred Stock shall be given the same choice as to the Alternate
  Consideration it receives in such Fundamental Transaction.</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"><I>Stockholder Subscription Agreement and Debenture</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">In connection with the Transactions, on December
  15, 2023, Onconetix entered into a Subscription Agreement (the &ldquo;Subscription Agreement&rdquo;) with the Investor for a private placement
  of $5.0 million of units (the &ldquo;Units&rdquo;), each unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant
  (collectively, the &ldquo;Warrants&rdquo;) to purchase 0.3 shares of Common Stock at an exercise price of $0.001 per share, for an aggregate
  purchase price per Unit of $0.25 (the &ldquo;Purchase Price&rdquo;). Additional shares are issuable to the Investor to the extent the
  Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than the Purchase
  Price, as set forth in the Subscription Agreement.</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; text-indent: 0.25in; text-align: justify">The offering is expected to close following stockholder
  approval of the issuance of the Conversion Shares. Within 30 days after closing, Onconetix will file a resale registration statement with
  the SEC registering the resale of the Common Stock issuable pursuant to the Subscription Agreement and the Warrants.</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; text-indent: 0.25in; text-align: justify">On January 23, 2024, Onconetix issued a non-convertible
  debenture (the &ldquo;Debenture&rdquo;) to the Investor in the principal sum of $5.0 million, the payment of which shall offset the Purchase
  Price for the Units pursuant to the Subscription Agreement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 14; 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 -->
  
  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify">The Debenture has an interest rate of 4.0% per annum, and the
  principal and accrued interest are repayable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June
  30, 2024. Additionally, the $5.0 million subscription amount under the Subscription Agreement shall be increased by the amount of interest
  payable under the Debenture.</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>ENTADFI</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On April&nbsp;19, 2023, the Company entered into
  the Veru APA. Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets
  related to Veru&rsquo;s ENTADFI&nbsp;business and assumed certain liabilities of Veru. The Transaction closed on April&nbsp;19, 2023.</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; text-indent: 0.25in; text-align: justify">The Company purchased substantially all of Veru&rsquo;s
  assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below). The acquisition
  of ENTADFI capitalizes on the demonstrable success of the FDA-approved drug ENTADFI&nbsp;for treating benign prostatic hyperplasia and
  counteracting negative sexual side effects seen in men on alternative BPH therapies.</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; text-indent: 0.25in; text-align: justify">Pursuant to the terms of the Veru APA, the Company
  agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the
  Transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an
  additional $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April 19,
  2024 and September 30, 2024. On September 29, 2023, the Company entered into an amendment (the &ldquo;Amendment&rdquo;) of the Veru APA.
  Pursuant to the Amendment, the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon
  (1) the payment to Veru of $1 million in immediately available funds on September 29, 2023, and (2) the issuance to Veru by October 3,
  2023 of 3,000 shares of Series A Preferred Stock of the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">The terms of the Series A Preferred Stock are
  set forth in the Certificate of Designations, which was filed with the State of Delaware on September 29, 2023. Pursuant to the Certificate
  of Designations, each share of Series A Preferred Stock will convert one year from the date of issuance of the Series A Preferred Stock
  into that number of shares of the Company&rsquo;s common stock determined by dividing the Stated Value (as defined in the Certificate
  of Designations) of $1,000 per share by the Conversion Price (as defined in the Certificate of Designations) of $0.5254 per share, subject
  to adjustment as provided in the Certificate of Designations, subject to certain shareholder approval limitations. The Series A Preferred
  Stock is entitled to share ratably in any dividends paid on the Company&rsquo;s common stock (on an as-if-converted-to-common-stock basis),
  has no voting rights except as to certain significant matters specified in the Certificate of Designations, and has a liquidation preference
  equal to the Stated Value of $1,000 per share plus any accrued but unpaid dividends thereon. The Series A Preferred Stock is redeemable
  in whole or in part at the Company&rsquo;s option at any time. The Certificate of Designations authorized the issuance of up to 10,000
  shares of Series A Preferred Stock.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">The Series A Preferred Stock issued to Seller
  is initially convertible, in the aggregate, into approximately 5,709,935 shares of the Company&rsquo;s common stock, subject to adjustment
  and certain shareholder approval limitations specified in the Certificate of Designations. Pursuant to the Amendment, the Company agreed
  to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023. The Company also agreed to include the
  shares of common stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the
  SEC.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Additionally, the terms of the Veru APA require
  the Company to pay Veru up to an additional $80.0 million based on the Company&rsquo;s net sales from the ENTADFI&nbsp;business after
  closing. The Milestone Payments are payable as follows: (i)&nbsp;$10.0 million is payable if the Company&rsquo;s annual net sales from
  the ENTADFI&nbsp;business equal or exceed $100.0 million, (ii)&nbsp;$20.0 million is payable if the Company&rsquo;s annual net sales from
  the ENTADFI&nbsp;business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI&nbsp;business
  equal or exceed $500.0 million. No more than one Milestone Payment shall be made for the achievement of each net sales milestone. There
  can be no assurance that the net sales milestones for payment of any of the Milestone Payments will be reached.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">Furthermore, in connection with the Transaction,
  the Company assumed&nbsp;royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered
  into by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017. The Camargo Obligations assumed by the Company include a 6%
  royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million as follows: (i)&nbsp;$5.0 million is
  payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii)&nbsp;$7.5 million
  is payable upon the first time the Company achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $10.0 million
  is payable upon the first time the Company achieves net sales from ENTADFI of $300.0 million during a calendar year.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt"></P>
  
  <!-- Field: Page; Sequence: 15; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>WraSer</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; text-indent: 0.25in; text-align: justify">On June 13, 2023 (the &ldquo;Execution Date&rdquo;),
  the Company entered into an asset purchase agreement with WraSer, LLC,&nbsp;a Mississippi limited liability company,&nbsp;Xspire Pharma,
  LLC,&nbsp;a Mississippi limited liability company (collectively, the &ldquo;Seller&rdquo;), and&nbsp;Legacy-Xspire Holdings, LLC,&nbsp;a
  Delaware limited liability company and the parent company of the Seller (&ldquo;Parent&rdquo;) (the &ldquo;WraSer APA&rdquo;). Pursuant
  to, and subject to the terms and conditions of, the WraSer APA, on the Closing Date (as defined below) the Company will purchase six FDA-approved
  pharmaceutical assets across several indications, including cardiology, otic infections, and pain management (the &ldquo;WraSer Assets&rdquo;).</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; text-indent: 0.25in; text-align: justify">Under the terms of the WraSer APA, the Company
  will purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA (the &ldquo;Signing Cash&rdquo;); (ii) $4.5
  million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the
  WraSer APA are met or otherwise waived (the &ldquo;Closing Date&rdquo;); (iii) 1.0 million shares of the Company&rsquo;s common stock
  (the &ldquo;Closing Shares&rdquo;) issuable on the Closing Date, and (iv) $500,000 in cash one year from the Closing Date. The closing
  of the transaction is subject to certain customary closing conditions and the delivery to the Company of financial statements of Seller
  and Parent for the fiscal years ended December 31, 2022 and 2021 audited by a qualified auditor reasonably acceptable to the Company.</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; text-indent: 0.25in; text-align: justify">Within 90 days of the Closing Date, the Company
  will use its best efforts to file with the SEC, (at its sole cost and expense,) a registration statement to register on Form S-3 registering
  under the Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;), the resale of the Closing Shares and will use its best
  efforts to have the registration statement declared effective as soon as practicable after filing.</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; text-indent: 0.25in; text-align: justify">In conjunction with the WraSer APA, the Company and the Seller entered
  into a Management Services Agreement (the &ldquo;MSA&rdquo;) on the Execution Date. Pursuant to the terms of the MSA, the Company was
  to act as the manager of the Seller&rsquo;s business during the period between the Execution Date and Closing Date. During this period,
  the Company was to make advances to WraSer, if needed to sustain operations. The Company&rsquo;s involvement as manager of the Seller&rsquo;s
  business ended when WraSer filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court (see below). If, on the
  Closing Date, the Seller&rsquo;s cash balance is in excess of the target amount specified in the MSA of $1.1 million (the &ldquo;Cash
  Target&rdquo;), the Company was to apply that excess to the $4.5 million cash payment due upon closing. Conversely, if there is a shortfall,
  the Company would have been required to remit the difference to the Seller over time. Specifically, as the Company collected accounts
  receivable generated after the Closing Date, the Company would have been required to remit 50% of the collections to the Seller until
  the shortfall is paid in full. The MSA terminates on the Closing Date.</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; text-indent: 0.25in; text-align: justify">The WraSer APA can be terminated prior to closing
  as follows (i) upon agreement with all parties; (ii) upon breach of contract of either party, uncured within 20 days of notice. If the
  WraSer APA is terminated upon agreement with all parties or upon uncured breach of contract by the Seller, the initial $3.5 million payment
  is retained by the Sellers. If it is determined that there is an uncured breach of contract by the Seller, and the WraSer APA is terminated,
  the Company will have an unsecured claim against WraSer for the $3.5 million payment made by the Company upon execution of the WraSer
  APA. The closing of the Transaction is subject to various closing conditions, including submission of the FDA transfer documentation to
  transfer ownership of the acquired product regulatory approvals to the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On September 26, 2023, WraSer and its affiliates
  filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court.&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt"></P>
  
  <!-- Field: Page; Sequence: 16; Value: 1 -->
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On October 4, 2023, the parties agreed to amend
  the WraSer APA. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the WraSer APA as amended. The amendment,
  among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million cash payment that the
  Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments
  of $150,000 commencing January 2024 (the &ldquo;Post-Closing Payment&rdquo;) and (iii) 789 shares of Series A Preferred Stock to be paid
  at closing. The amendment also reduced the number of products we were acquiring by excluding pain medications and including only (i) Ciprofloxacin
  0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic Version approved under US FDA NDA No.
  208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity
  approved under US FDA NDA N204886.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">In October 2023, we were alerted by WraSer that
  its sole manufacturer for the active pharmaceutical ingredient (&ldquo;API&rdquo;) for Zontivity, the key driver for the WraSer acquisition,
  would no longer manufacture the API for Zontivity. We believed that this development constituted a Material Adverse Effect under the APA
  enabling us to terminate the APA and MSA. On October 20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy
  Court to exercise our termination rights under the WraSer APA, as amended. On December 18, 2023, the Bankruptcy Court entered an Agreed
  Order lifting the automatic stay to enable us to exercise our rights to terminate the APA and the MSA without prejudice to the parties&rsquo;
  respective rights, remedies, claims and defenses they had against one another under the APA and MSA. On December 21, 2023, we filed a
  Notice with the Bankruptcy Court terminating the APA and MSA. WraSer has advised us that it does not believe that a Material Adverse Event
  occurred. Due to the WraSer bankruptcy filing and our status as an unsecured creditor of WraSer, it is also unlikely that we will recover
  the $3.5 million Signing Cash or any costs and resources in connection with services provided by the Company under the WraSer MSA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Agreement with Cardinal Health</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On September 21, 2023,
  the Company entered into an Exclusive Distribution Agreement (the &ldquo;Exclusive Distribution Agreement&rdquo;), effective as of
  September 20, 2023 (the &ldquo;Effective Date&rdquo;), with Cardinal Health 105, LLC (&ldquo;Cardinal Health&rdquo;). Pursuant to,
  and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its
  exclusive third-party logistics distribution agent for sales of all of the Company&rsquo;s commercial assets. The term of the
  Distribution Agreement is three years from the Effective Date and automatically renews for additional terms of one year each unless
  terminated pursuant to the terms of the Exclusive Distribution Agreement. Under the terms of the Exclusive Distribution Agreement,
  the Company must pay to Cardinal Health a one-time start-up fee of $15,500, and upon launch of ENTADFI, a monthly account management
  fee of $7,000, and other fees for various services, including post-launch program implementation, information systems, warehouse
  operations, and financial services.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>Corporate Name Change and Amendment to Bylaws</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On December 15, 2023, the Company filed an amendment
  to its A&amp;R COI with the Secretary of State of Delaware to change its corporate name from &ldquo;Blue Water Biotech, Inc.&rdquo; to
  &ldquo;Onconetix, Inc.&rdquo;</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; text-indent: 0.25in; text-align: justify">In connection with the name change, the Company
  also amended the Company&rsquo;s bylaws to reflect the new corporate name.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On May 31, 2023, the Board amended the Company&rsquo;s
  bylaws to reduce the quorum requirement at meetings of the Company&rsquo;s stockholders from a majority of the voting power of the outstanding
  shares of stock of the Company entitled to vote, to one-third of the voting power of the outstanding shares of stock of the Company entitled
  to vote, effective immediately. No other changes were made to the bylaws.</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"><B>Warrant Inducement</B>&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">On July 31, 2023, the Company entered into the
  Inducement Letter with the Holder of the Existing PIOs. Pursuant to the Inducement Letter, the Holder agreed to exercise for cash its
  Existing PIOs to purchase an aggregate of 2,486,214 shares of the Company&rsquo;s common stock, at a reduced exercise price of $1.09 per
  share, in exchange for the Company&rsquo;s agreement to issue Inducement PIOs to purchase up to 4,972,428 shares of the Company&rsquo;s
  common stock. The Inducement PIOs have substantially the same terms as the Existing PIOs. On August 2, 2023, the Company consummated the
  Warrant Inducement. The Company received aggregate net proceeds of approximately $2.3 million from the Warrant Inducement, after deducting
  placement agent fees and other offering expenses payable by the Company.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 17; Value: 1 -->
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  <DIV STYLE="padding-right: 3pt; padding-left: 3pt; border: Black 1.5pt solid">
  
  <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; text-indent: 0.25in; text-align: justify">The Company engaged Wainwright to act as its placement
  agent in connection with the Warrant Inducement and paid Wainwright a cash fee equal to 7.5% of the gross proceeds received from the exercise
  of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company
  also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement
  PIOs, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable
  expenses in the amount of $35,000. In addition, the exercise for cash of the Existing PIOs triggered the issuance to Wainwright or its
  designees, warrants to purchase 149,173 shares of common stock, which were issuable in accordance with the terms of Contingent Warrants
  issuable to Wainwright in connection with the August 2022 Private Placement Transaction, and have the same terms as the Inducement PIOs,
  except for an exercise price equal to $1.3625 per share. The Company also agreed to issue warrants to Wainwright upon any exercise for
  cash of the Inducement PIOs, that number of shares of common stock equal to 6.0% of the aggregate number of such shares of common stock
  underlying the Inducement PIOs that have been exercised, also with an exercise price of $1.3625. The maximum number of warrants issuable
  under this provision is 298,346.</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>Nasdaq Compliance</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; text-indent: 0.25in; text-align: justify">On September 18, 2023, we received notice from
  Nasdaq staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were
  not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth
  in Nasdaq Listing Rule 5550(a)(2) (the &ldquo;Bid Price Rule&rdquo;). We have 180 days from September 18, 2023, or through March 16, 2024,
  to regain compliance with the Bid Price Rule.</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; text-indent: 0.25in; text-align: justify">On August 22, 2023, we received a notice from
  Nasdaq that we were not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to timely file all required
  periodic financial reports with the SEC, given our failure to timely file our quarterly report on Form 10-Q for the quarter ended
  June 30, 2023. On October 20, 2023, we filed our Form 10-Q for the period ended June 30, 2023, and on November 1, 2023, we announced that
  we had regained compliance with Nasdaq Listing Rule 5250(c)(1).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 18; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-indent: 0.25in; text-align: justify">&nbsp;</P>
  
  
  
  
  <!-- Field: Split-Segment; Name: 001 -->
  <DIV STYLE="border: white 1pt solid; text-indent: 0.25in; padding: 0cm"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Corporate Information</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in; background-color: white">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 <I>www.onconetix.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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>The Offering</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&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="text-align: justify; width: 28%"><FONT STYLE="font-size: 10pt"><B>Outstanding Common Stock:</B></FONT></TD>
      <TD STYLE="text-align: justify; width: 2%">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 70%"><FONT STYLE="font-size: 10pt">22,324,576 shares of our Common Stock are outstanding as of January 25, 2024.</FONT></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"><FONT STYLE="font-size: 10pt"><B>Common Stock Offered:</B></FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Up to 885,796 shares of Common Stock for sale by the Selling Stockholders (which include our employees, consultants, executive officers and directors) for their own account pursuant to the 2022 Plan.</FONT></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"><FONT STYLE="font-size: 10pt"><B>Selling Stockholders:</B></FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">The Selling Stockholders are set forth in the section entitled &ldquo;Selling Stockholders&rdquo; of this reoffer prospectus on page 40. 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(i).</FONT></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"><FONT STYLE="font-size: 10pt"><B>Use of proceeds:</B></FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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.</FONT></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"><FONT STYLE="font-size: 10pt"><B>Risk Factors:</B></FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">The securities offered hereby involve a high degree of risk. See &ldquo;Risk Factors.&rdquo;</FONT></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"><FONT STYLE="font-size: 10pt"><B>Nasdaq Capital Market trading symbol:</B></FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">ONCO</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  </DIV>
  
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><A NAME="b_004"></A><B>CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
  AND INDUSTRY AND MARKET DATA</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Special Note Regarding Forward-Looking Statements</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our projected financial position and estimated cash burn rate;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our estimates regarding expenses, future revenues and capital requirements;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to continue as a going concern;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our need to raise substantial additional capital to fund our operations;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the success, cost and timing of our future clinical
      trials;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to obtain and maintain the necessary regulatory approvals
      to market and commercialize our products and future product candidates;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the potential that results of pre-clinical and clinical trials indicate any future product candidates we may seek to develop are unsafe or ineffective;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the results of market research conducted by us or others;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to obtain and maintain intellectual property protection for our current product candidates;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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;</FONT></TD></TR>
    </TABLE>
  <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"></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-top: 0pt; margin-bottom: 0pt; 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: 0.25in; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our reliance on third parties, including manufacturers and logistics companies;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the success of competing therapies and products that are or become available;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to commercialize ENTADFI and Proclarix and integrate the assets and commercial operations acquired;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to successfully compete against current and future competitors;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our ability to expand our organization to accommodate growth and our ability to retain and attract key personnel;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">market acceptance of our products and 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</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the successful development of our commercialization capabilities, including sales and marketing capabilities.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Government Regulation and Product Approval</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>United States</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>U. S. Biopharmaceuticals Regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">The process required by the
  FDA before drug and biologic product candidates may be marketed in the United States generally involves the following:</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">submission to the FDA of an investigational new drug application, IND, which must become effective before clinical trials may begin;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">approval by an independent institutional review board or ethics committee at each clinical site before the trial is commenced;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">satisfactory completion of an FDA Advisory Committee review, if applicable;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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 States.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Preclinical and Clinical Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt"><I>&#9679;</I></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><I>Phase 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.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt"><I>&#9679;</I></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><I>Phase 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.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><I>Phase 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.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>NDA/BLA Submission and Review</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Expedited Development and Review Programs</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 months of the 60-day filing date.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Orphan Drug Designation</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Post-Approval Requirements</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">fines, warning or untitled letters or holds on post-approval clinical studies;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">product seizure or detention, or refusal of the FDA to permit the import or export of products;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">mandated modification of promotional materials and labeling and the issuance of corrective information;</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">injunctions or the imposition of civil or criminal penalties.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>U.S. Market Exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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 &ldquo;Written Request&rdquo;
  for such a study.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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. &ldquo;First licensure&rdquo;
  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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Pediatric Study Plan and Pediatric Exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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 &ldquo;Written Request&rdquo; for such a study.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Patent Term Restoration and Extension</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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 &ldquo;remuneration&rdquo; 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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 &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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Healthcare Reform</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>Coverage and Reimbursement</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">The future commercial success
  of our products  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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&rsquo;s product could adversely affect the sales of our product candidates.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">Since its enactment, there
  have been judicial and Congressional challenges to certain aspects of the ACA, and we expect such challenges and amendments to continue.
  Since January 2017, Former 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 &ldquo;individual
  mandate.&rdquo; 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 &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 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 &ldquo;donut hole.&rdquo; 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&rsquo;s budget proposal for fiscal year 2019 contains
  further drug price control measures that could be enacted during the 2019 budget process or in other future legislation. Additionally,
  the Trump administration released a &ldquo;Blueprint&rdquo; to lower drug prices and reduce out of pocket costs of drugs that contains
  additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize
  manufacturers to lower the list price of their products and reduce the out-of-pocket costs of drug products paid by consumers. In August
  2022, Congress passed the Inflation Reduction Act of 2022, which included a provision allowing Medicare to negotiate drug prices directly
  with pharmaceutical manufacturers. This provision may impact pricing strategies and determinations in the future. 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>Foreign Regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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 &euro;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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>European Union</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>European Union Coverage Reimbursement and
  Pricing</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>EU Drug regulation</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Non-clinical studies and clinical trials</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">Similarly to the United 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Marketing Authorizations</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; 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">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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. 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</FONT></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>&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify"><FONT 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.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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&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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Data and marketing exclusivity</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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&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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I></I></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Pediatric Development</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Post-Approval Requirements</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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).</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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. 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Privacy and data protection laws</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">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 &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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Japan</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><I>Japanese drug regulation</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Non-clinical studies and clinical trials</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 States or EU.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 States.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><I>&nbsp;</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Product approval</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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) 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><I>Licensing requirement</I></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 years.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Employees</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">As of January 25, 2024, we
  had 5 full-time and 11 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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Properties and Facilities</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">We currently lease an office
  located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">Additionally, Proteomedix leases
  office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expires on June 30, 2025, subject to renewal for
  successive two-year terms.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B>Legal Proceedings</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">From time to time we may be
  involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any
  material legal proceedings.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: left"><B><U>Other</U></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; text-indent: 0.25in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: justify; 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 <I>www.onconetix.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; text-indent: 0.25in; margin-top: 0pt; margin-bottom: 0pt; text-align: justify">&nbsp;</P>
  
  
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  <!-- Field: Split-Segment; Name: 002 -->
  <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-top: 0pt; margin-bottom: 0pt; text-align: center"><B><A NAME="b_005"></A>RISK FACTORS</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; 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: 36pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; text-align: justify; 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 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; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>There is substantial doubt about our ability
  to continue as a &ldquo;going concern.&rdquo;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company has incurred substantial operating
  losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2023,
  the Company had cash of approximately $7.7&nbsp;million, a working capital deficit of approximately $8.1&nbsp;million and an accumulated
  deficit of approximately $34.4 million.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The Company will require significant additional capital to fund its
  continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the Company&rsquo;s working capital
  needs and business activities, including making the remaining payments to Veru, the commercialization of ENTADFI and Proclarix, and the
  development and commercialization of its current product candidates and future product candidates. In addition, if Stockholder Approval
  is not obtained by January 1, 2025, the Company may be obligated to cash settle the Series B Convertible Preferred Stock. Management&rsquo;s
  plans include generating product revenue from sales of ENTADFI, which is subject to further successful commercialization activities, and
  Proclarix, which may still be subject to further successful commercialization activities within certain jurisdictions. Certain of the
  commercialization activities are outside of the Company&rsquo;s control, including but not limited to, securing contracts with wholesalers
  and third party payers, securing contracts with third-party logistics providers, obtaining required licensure in various jurisdictions,
  as well as attempting to secure additional required funding through equity or debt financings if available. However, there are currently
  no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable
  terms, if at all. If the Company is unable to secure additional capital, it may be required to delay or curtail any future clinical trials,
  development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order
  to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These conditions raise substantial doubt about
  the Company&rsquo;s ability to continue as a going concern for a period of time within one year after the date of the issuance of the
  condensed financial statements incorporated by reference in this Registration Statement.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We entered into an asset purchase agreement
  and management services agreement with WraSer, which have been terminated because we believe that a material adverse event has occurred
  with respect to the WraSer Assets. However, the termination is subject to WraSer&rsquo;s right to challenge the termination and assert
  claims against us</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On June 13, 2023, we entered into the WraSer APA
  and MSA with WraSer in connection with the purchase of the WraSer Assets. Under the WraSer APA, we paid $3.5 million in cash to WraSer
  at signing (the &ldquo;Signing Cash&rdquo;).In October 2023, we were alerted by WraSer that its sole manufacturer for the active pharmaceutical
  ingredient (&ldquo;API&rdquo;) for Zontivity, the key driver for the WraSer acquisition, would no longer manufacture the API for Zontivity.
  We believed that this development constituted a Material Adverse Effect under the APA enabling us to terminate the APA and MSA. On October
  20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy Court to exercise our termination rights under the WraSer
  APA, as amended. On December 18, 2023, the Bankruptcy Court entered an Agreed Order lifting the automatic stay to enable us to exercise
  our rights to terminate the APA and the MSA without prejudice to the parties&rsquo; respective rights, remedies, claims and defenses they
  had against one another under the APA and MSA. On December 21, 2023, we filed a Notice with the Bankruptcy Court terminating the APA and
  MSA. WraSer has advised us that it does not believe that a Material Adverse Event occurred. Due to the WraSer bankruptcy filing and our
  status as an unsecured creditor of WraSer, it is also unlikely that we will recover the $3.5 million Signing Cash or any costs and resources
  in connection with services provided by the Company under the WraSer MSA.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Company shareholders may not realize a benefit
  from the ENTADFI&nbsp;or Proteomedix acquisitions commensurate with the ownership dilution they will experience in connection with the
  transactions.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If the Company is unable to realize the full strategic
  and financial benefits currently anticipated from the recent ENTADFI and Proteomedix acquisitions, our shareholders may experience a dilution
  of their ownership interests our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit
  to the extent the Company is able to realize only part of the strategic and financial benefits currently anticipated from the transactions.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>The issuance or conversion of securities
  would result in significant dilution in the equity interest of existing shareholders and adversely affect the marketplace of the securities.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">The issuance or conversion of common shares or
  other securities convertible into common shares would result in significant dilution in the equity interest of existing shareholders and
  adversely affect the market price of the common shares. We have issued 3,000 shares of Series A Preferred Stock to Veru which are initially
  convertible one year from issuance, in the aggregate, into 5,709,935 shares of the Company&rsquo;s common stock, subject to adjustment
  and certain shareholder approval limitations specified in the Certificate of Designations. We have issued <FONT STYLE="background-color: white">2,696,729
  </FONT>shares of Series B Preferred Stock to former shareholders of Proteomedix which are initially convertible, in the aggregate, into
  <FONT STYLE="background-color: white">269,672,900 </FONT>shares of the Company&rsquo;s common stock, subject to adjustment and certain
  shareholder approval limitations specified in the Certificate of Designations.</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"><B><I>We may have violated Section 13(k) of the
  Exchange Act (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Section 13(k) of the Exchange Act provides that
  it is unlawful for a company that has a class of securities registered under Section 12 of the Exchange Act to, directly or indirectly,
  including through any subsidiary, extend or maintain credit in the form of a personal loan to or for any of its directors or executive
  officers. In the fiscal year ended December 31, 2022 and the nine months ended September 30, 2023, we paid certain expenses of our former
  Chief Executive Officer and Chairman of the Board, which may be deemed to be personal loans made by us to our former Chief Executive Officer
  and Chairman of the Board that are not permissible under Section 13(k) of the Exchange Act. Issuers that are found to have violated Section
  13(k) of the Exchange Act may be subject to civil sanctions, including injunctive remedies and monetary penalties, as well as criminal
  sanctions. The imposition of any of such sanctions on us could have a material adverse effect on our business, financial position, results
  of operations or cash flows.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>Misconduct and errors by our current and
  former employees and our third-party service providers could cause a material adverse effect on our business and reputation.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our employees and third-party service providers
  are integral to our business operations, including confidential information. If any such information were leaked to unintended recipients
  due to human error, theft, malicious sabotage or fraudulent manipulation, we may be subject to liability for loss of such information.
  Further, if any of our employees or third-party service providers absconded with our proprietary data or know-how in order to compete
  with us, our competitive position may be materially and adversely affected.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Any improper conduct or use of funds&nbsp;by any
  of our employees or third-party service providers in contravention of our protocols and policies may lead to regulatory and disciplinary
  proceedings involving us. We may be perceived to have facilitated or participated in such conduct and we could be subject to liability,
  damages, penalties and reputational damage. It is impossible to completely identify and eradicate all risks of misconduct or human errors,
  and our precautionary measures may not be able to effectively detect and prevent such risks from happening.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Occurrence of any of the above risks could result
  in a material adverse effect on our business and results of operations, as we are exposed to potential liability to borrowers and investors,
  reputational damage, regulatory intervention, financial harm. Our ability to attract new and retain existing borrowers and investors and
  operate as an ongoing concern may be impaired.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I></I></B></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may consider strategic alternatives in
  order to maximize stockholder value, including financing, 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 not be successful.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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 business activities because they may be
  deemed to be at too early of a stage of development for collaborative effort. Any delays in entering into new strategic partnership agreements
  harm our business prospects, financial condition and results of operations.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">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; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>As a result of our failure to timely file
  our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, we are currently&nbsp;ineligible&nbsp;to file new short form registration
  statements on Form&nbsp;S-3, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Form S-3 permits eligible issuers to conduct registered
  offerings using a short form registration statement that allows the issuer to incorporate by reference its past and future filings and
  reports made under the&nbsp;Securities Exchange Act of 1934, as amended, or the&nbsp;Exchange Act. In addition, Form S-3 enables eligible
  issuers to conduct primary offerings &ldquo;off the shelf&rdquo; under Rule 415 of the&nbsp;Securities Act of 1933, as amended, or the&nbsp;Securities
  Act. The shelf registration process, combined with the ability to forward incorporate information, allows issuers to avoid delays and
  interruptions in the offering process and to access the capital markets in a more expeditious and efficient manner than raising capital
  in a standard registered offering pursuant to a Registration Statement on Form S-1.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As a result of our failure to timely file our
  Quarterly Report on Form 10-Q for quarter ended June 30, 2023, we are currently&nbsp;ineligible&nbsp;to file new short form registration
  statements on Form&nbsp;S-3&nbsp;and we will be unable to conduct &ldquo;off the shelf&rdquo; offerings under Rule&nbsp;415&nbsp;of the&nbsp;Securities
  Act&nbsp;using our currently effective Registration Statement on Form S-3 (File No. 333-270383) after we file our annual report for the
  fiscal year ending December 31, 2023. As a result, we may be unable to conduct an &ldquo;at the market&rdquo; offering pursuant to our
  At The Market Offering Agreement with H.C. Wainwright &amp; Co., LLC after such date. In addition, if we seek to access the capital markets
  through a registered offering during the period of time that we are unable to use Form S-3, we may be required to publicly disclose the
  proposed offering and the material terms thereof before the offering commences, we may experience delays in the offering process due to
  SEC review of a Form S-1 registration statement and we may incur increased offering and transaction costs and other considerations. Disclosing
  a public offering prior to the formal commencement of an offering may result in downward pressure on our stock price. In addition, our
  inability to conduct an offering &ldquo;off the shelf&rdquo; may require us to offer terms that may not be advantageous (or may be less
  advantageous) to us or may generally reduce our ability to raise capital in a registered offering. If we are unable to raise capital through
  a registered offering, we would be required to conduct our financing transactions on a private placement basis, which may be subject to
  pricing, size and other limitations imposed under Nasdaq rules.</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: 41; Value: 1 -->
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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: justify"><B><I>If we fail to maintain proper and effective
  internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. 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-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are subject to the reporting requirements of
  the Exchange Act, the Sarbanes-Oxley Act and Nasdaq rules and regulations. The Sarbanes-Oxley Act requires, among other things, that we
  maintain effective disclosure controls and procedures and internal control over financial reporting. Effective internal control over financial
  reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is
  designed to prevent fraud. We must perform system and process evaluation and testing of our internal controls over financial reporting
  to allow&nbsp;management to report on the effectiveness of our internal controls over financial reporting in our Annual Report on Form
  10-K for each year, as required by Section 404 of the Sarbanes-Oxley Act (&ldquo;Section 404&rdquo;). This requires significant management
  efforts and requires us to incur substantial professional fees and internal costs to expand our accounting and finance functions. Any
  failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to
  meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404, or any
  subsequent testing by our independent registered public accounting firm, as and when required, may reveal deficiencies in our internal
  controls over financial reporting that are deemed to be significant deficiencies or material weaknesses or that may require prospective
  or retroactive changes to our financial statements, or may identify other areas for further attention or improvement. Furthermore, we
  cannot be certain that our efforts will be sufficient to remediate or prevent future material weaknesses or significant deficiencies from
  occurring.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We do not yet have effective disclosure controls
  and procedures, or internal controls over all aspects of our financial reporting. Specifically, we have identified the following control
  deficiencies which we believe are material weaknesses.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">We did not maintain an effective
  control environment as there was an inadequate segregation of duties with respect to certain cash disbursements. The processing and the
  approval for payment of credit card transactions and certain bank wires were being handled by the former CEO and an accounting employee,
  and the accounting employee was responsible for the reconciliation of credit card statements and bank statements. This allowed these
  individuals to submit unauthorized payments to unauthorized third parties.</FONT></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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">We did not have an effective
  risk assessment process over the identification of fraud risks surrounding the authorization, identification, approval and reporting
  of personal expenses charged to the Company&rsquo;s corporate credit cards.</FONT></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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify">We did not design and maintain effective monitoring of compliance
  with established accounting policies and procedures.</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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Our controls over the approval
  and reporting of expenses paid with the Company&rsquo;s credit cards and certain bank wires were not designed and maintained to achieve
  the Company&rsquo;s objectives.</FONT></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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">We&nbsp;failed to employ a
  sufficient number of staff to maintain optimal segregation of duties, maintain adequate internal controls surrounding information technology
  procedures, such as a lack of a written information security policy, maintain adequate controls over the approval and posting of journal
  entries, and to provide optimal levels of oversight in order to process financial information in a timely manner,&nbsp;analyze and account
  for complex, non-routine transactions,&nbsp;and prepare financial statements.</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">We do not yet have adequate
  internal controls in place for the timely identification, approval or reporting of related party transactions.</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We cannot provide assurances that these weaknesses
  will be effectively remediated or that additional material weaknesses will not occur in the future.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">As a result of the material weaknesses in our
  internal controls over financial reporting described above, and other matters raised or that may in the future be raised by the SEC, we
  may face for the prospect of litigation or other disputes which may include, among others, claims invoking the federal and state securities
  laws, contractual claims or other claims arising from the material weaknesses in our internal control over financial reporting and the
  preparation of our financial statements, any of which claims could result in adverse effects to our business. As of the date hereof, we
  have no knowledge of any such litigation or dispute.</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: justify"><B><I>We expect to rely on third party manufacturers
  for ENTADFI and Proclarix.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">For the foreseeable future, we expect to and do
  rely on third-party manufacturers and other third parties to produce, package and store sufficient quantities of ENTADFI and Proclarix
  to meet demand. ENTADFI and Proclarix is complicated and expensive to manufacture. If our third-party manufacturers fail to deliver ENTADFI
  or Proclarix for commercial sale on a timely basis, with sufficient quality, and at commercially reasonable prices, we may be required
  to delay or suspend commercial sales and/or production of ENTADFI and Proclarix. While we may be able to identify replacement third-party
  manufacturers or develop our own manufacturing capabilities for ENTADFI and Proclarix, this process would likely cause a delay in the
  availability of ENTADFI and/or Proclarix and an increase in costs. In addition, third-party manufacturers may have a limited number of
  facilities in which ENTADFI and Proclarix can be produced, and any interruption of the operation of those facilities due to events such
  as equipment malfunction or failure or damage to the facility by natural disasters could result in the cancellation of shipments, loss
  of product in the manufacturing process or a shortfall in ENTADFI and Proclarix.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, regulatory requirements could pose
  barriers to the manufacture of ENTADFI and Proclarix. Third-party manufacturers are required to comply with the FDA&rsquo;s cGMPs. As
  a result, the facilities used by any manufacturers of ENTADFI Proclarix, must maintain a compliance status acceptable to the FDA. Holders
  of NDAs, or other forms of FDA approvals or clearances, or those distributing a regulated product under their own name, are responsible
  for manufacturing even though that manufacturing is conducted by a third-party contract manufacturing organization (&ldquo;CMO&rdquo;).
  Our third-party manufacturers will be required to produce ENTADFI and Proclarix under FDA cGMPs in order to meet acceptable standards.
  Our third-party manufacturers may not perform their obligations under their agreements with us or may discontinue their business before
  the time required by us to commercialize our drug candidates. In addition, our manufacturers will be subject to ongoing periodic unannounced
  inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. Failure
  by any of our manufacturers to comply with applicable cGMPs could result in sanctions being imposed on us, including fines, injunctions,
  civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply, recalls, withdrawals,
  issuance of safety alerts and criminal prosecutions, any of which could have a material adverse effect on our business, financial condition,
  results of operations and prospects. Finally, we also could experience manufacturing delays if our CMOs give greater priority to the supply
  of other products over ENTADFI or Proclarix or otherwise do not satisfactorily perform according to the terms of their agreements with
  us.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If any supplier for ENTADFI or Proclarix experiences
  any significant difficulties in its manufacturing processes, does not comply with the terms of the agreement between us or does not devote
  sufficient time, energy and care to providing our manufacturing needs, we could experience significant interruptions in the supply of
  ENTADFI and/or Proclarix, which could impair our ability to supply ENTADFI and/or Proclarix at the levels required for commercialization
  and prevent or delay its successful development and commercialization.</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"><B><I>Disruptions to or significantly increased
  costs associated with transportation and other distribution channels for ENTADFI and/or Proclarix may adversely affect our margins and
  profitability.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We expect to rely on the uninterrupted and efficient
  operation of third-party logistics companies to transport and deliver ENTADFI and Proclarix. These third-party logistics companies may
  experience disruptions to the transportation channels used to distribute our products, including disruptions caused by the COVID-19 pandemic,
  increased airport and shipping port congestion, a lack of transportation capacity, increased fuel expenses, and a shortage of manpower
  or capital or due to other business interruptions. Disruptions to the transportation channels experienced by our third-party logistics
  companies may result in increased costs, including the additional use of airfreight to meet demand. Disruptions to this business model
  or our relationship with the third party if, for example, performance fails to meet our expectations, could harm our business.</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"><B><I>We may fail or elect not to commercialize
  our products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may not successfully commercialize our products.
  We or our collaboration partners in any potential commercial marketing efforts of our products may not be successful in achieving widespread
  patient or physician awareness or acceptance of this product. Also, we may be subject to pricing pressures from competitive products or
  from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our products.
  Any failure to commercialize our products could have a material adverse effect on our future revenue and our business.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If we fail to commercialize our products, our
  business, financial condition, results of operations and prospects may be materially adversely affected and our reputation in the industry
  and in the investment community would likely be damaged.</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: justify"><B><I>We may not be able to gain and retain market
  acceptance for our products.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Physicians may not prescribe our products, which
  would prevent our products from generating revenue. Market acceptance of our products by physicians, patients and payors, will depend
  on a number of factors, many of which are beyond our control, including the following:</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">&#9679;<FONT STYLE="font-size: 10pt"></FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the clinical indications for
  which our products are approved, if at all;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">acceptance by physicians and
  payors of our products as safe and effective treatment or test;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the cost in relation to alternative
  treatments or tests;</FONT></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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the relative convenience and
  ease of administration of our products for the conditions for which they are intended;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the availability and efficacy
  of competitive drugs or tests;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the effectiveness of our sales
  and marketing efforts;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the extent to which our products
  are approved for inclusion on formularies of hospitals and managed care organizations;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the availability of coverage
  and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care programs,
  including Medicare and Medicaid;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">limitations or warnings contained
  in a product&rsquo;s FDA or other applicable regulatory agency&rsquo;s approved labeling; and</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">prevalence and severity of
  adverse side effects.</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Even if the medical community accepts that our
  products are safe and efficacious for its approved indications, physicians may not immediately be receptive to the use or may be slow
  to adopt such products as an accepted treatment or test for the conditions for which it is intended. Without head-to-head comparative
  data, we will also not be able to promote our products as being superior to competing products. If our products do not achieve an adequate
  level of acceptance by physicians and payors, we may not generate sufficient or any revenue from this product. In addition, our efforts
  to educate the medical community and third-party payors on the benefits of our product may require significant resources and may never
  be successful.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">In addition, even if our products achieve market
  acceptance, we may not be able to maintain that market acceptance over time if:</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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">new products or technologies
  are introduced that are more favorably received than our products, are more cost effective or render our products obsolete;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 34.4pt; 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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Unforeseen complications arise
  with respect to use of our products or</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 32.4pt; 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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">sufficient third-party insurance
  coverage or reimbursement does not remain available.</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: 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: justify"><B><I>ENTADFI is subject to competition from other
  BPH drugs and larger, well-established companies with substantially greater resources than us.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>&nbsp;</I></B></P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We are engaged in the marketing of a product in
  industries, including the pharmaceutical industry, that are highly competitive. The pharmaceutical industry is also characterized by extensive
  research and rapid technological progress. Potential competitors with respect to ENTADFI in North America, Europe and elsewhere include
  major pharmaceutical companies, specialty pharmaceutical companies and biotechnology firms, universities and other research institutions
  and government agencies. Many of our competitors have substantially greater research and development and regulatory capabilities and experience,
  and substantially greater management, manufacturing, distribution, marketing and financial resources, than we have. We may be unable to
  compete successfully against current and future competitors, and competitive pressures could have a negative effect on our net revenues
  and profit margins.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Other parties have developed and marketed drugs
  for BPH that have been accepted by the physician, patient and payor communities. Many of these other products have also reached the point
  where they are now generic drugs, which means that they are sold at a very low price, a price which ENTADFI may not be able to meet which
  could limit the reach of ENTADFI into the physician, patient and payor communities, including government payors.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B><I>We may not be able to successfully implement
  our strategy to grow sales of ENTADFI and Proclarix in the U.S. market or, if authorized, in any foreign market.</I></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">We may not be able to expand sales of ENTADFI
  or Proclarix through partnering with telemedicine or other partners or with commercial diagnostic providers or through our own commercialization
  efforts. We may not be able to command a price with private and government payors for ENTADFI or Proclarix that would justify our devotion
  of significant resources to attempting to grow sales of ENTADFI or Proclarix. We may not be able to compete efficiently or effectively
  in a mature BPH market which is heavily generic. Failure to grow sales of ENTADFI or Proclarix would have a negative effect on our revenue
  and future plans.</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"><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-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">Our continued eligibility for listing on Nasdaq
  depends on our ability to comply with Nasdaq&rsquo;s continued listing requirements.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On September 18, 2023, we received notice from
  Nasdaq staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were
  not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth
  in Nasdaq Listing Rule 5550(a)(2). We have 180 days from September 18, 2023, or through March 16, 2024, to regain compliance with the
  Bid Price Rule.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 16.2pt">&nbsp;</P>
  
  <P STYLE="text-indent: 0.25in; font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">If Nasdaq delists our common stock from trading
  on its exchange for failure to meet the Bid Price Rule or any other 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 32.4pt; text-align: justify; text-indent: -16.2pt">&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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a limited availability of market
  quotations for our securities;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 32.4pt; 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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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;</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 32.4pt; 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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a limited amount of analyst
  coverage; and</FONT></TD>
  </TR></TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 32.4pt; 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"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">a decreased ability to issue
  additional securities or obtain additional financing in the future.</FONT></TD>
  </TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><B></B></P>
  
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      <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"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B><A NAME="b_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-align: justify; text-indent: 0.25in">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: 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">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: 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">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-align: justify; 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">
      <TD STYLE="border-bottom: Black 1.5pt solid; vertical-align: bottom; font-weight: bold; text-align: left">Selling Stockholder</TD><TD STYLE="font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Principal<BR>
   Position with<BR> the Company (1)</TD><TD STYLE="font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="6" STYLE="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Shares Owned<BR> Prior to Resale</TD><TD STYLE="padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Number of <BR>
  Shares<BR> Offered for Resale</TD><TD STYLE="padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD><TD STYLE="font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="6" STYLE="font-weight: bold; text-align: center; border-bottom: Black 1.5pt solid">Shares Beneficially Owned<BR> After Resale</TD><TD STYLE="padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: center">&nbsp;</TD><TD STYLE="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Number(2)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD><TD STYLE="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Percent(3)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Number</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD><TD STYLE="text-align: center; font-weight: bold; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Percent(3)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt; font-weight: bold">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; width: 15%; text-align: left">Erin Henderson</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 24%; text-align: left">Former&nbsp;Chief&nbsp;Business&nbsp;Officer</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">342,682</TD><TD STYLE="width: 1%; text-align: left"><SUP>(4)</SUP></TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.5</TD><TD STYLE="width: 1%; text-align: left">%</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">&nbsp;&nbsp;317,930</TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">24,752</TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">James Sapirstein</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">56,935</TD><TD STYLE="text-align: left"><SUP>(5)</SUP></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">56,935</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">Simon Tarsh</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">10,433</TD><TD STYLE="text-align: left"><SUP>(6)</SUP></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">10,433</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">Timothy Ramdeen</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">8,746</TD><TD STYLE="text-align: left"><SUP>(7)</SUP></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">8,746</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">Brian Price</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Consultant</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">32,552</TD><TD STYLE="text-align: left"><SUP>(8)</SUP></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">32,552</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-indent: -10pt; padding-left: 10pt; vertical-align: top; text-align: left">Sunetra Gupta</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Advisory Board Member</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">459,200</TD><TD STYLE="text-align: left"><SUP>(9)</SUP></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">2.1</TD><TD STYLE="text-align: left">%</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">459,200</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&mdash;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  </TABLE>
  
  <P STYLE="margin: 0"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></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"><FONT STYLE="font-size: 10pt">*</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Less than 1%.</FONT></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 CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(1)</TD><TD STYLE="text-align: justify">All positions described are with the Company, unless otherwise indicated.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(2)</TD><TD STYLE="text-align: justify">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 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(3)</TD><TD STYLE="text-align: justify">Percentage is computed with reference to 22,324,576 shares of our Common Stock outstanding as of January
  30, 2024. In addition, we deemed outstanding shares of Common Stock subject to options or warrants held by each person for purposes of
  computing the percentage of ownership for such person. However, we did not deem such shares outstanding for the purpose of computing the
  percentage ownership of any other person.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(4)</TD><TD STYLE="text-align: justify">Includes 24,752 shares of Common Stock, 150,000 restricted shares of Common Stock, and 167,930 shares
  of Common Stock underlying options.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(5)</TD><TD STYLE="text-align: justify">Includes 6,360 restricted shares of Common Stock and 50,575 shares of Common Stock underlying options.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(6)</TD><TD STYLE="text-align: justify">Includes 6,360 restricted shares of Common Stock and 4,073 shares of Common Stock underlying options.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(7)</TD><TD STYLE="text-align: justify">Includes 6,360 restricted shares of Common Stock and 2,386 shares of Common Stock underlying options.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(8)</TD><TD STYLE="text-align: justify">Includes 32,552 shares of Common Stock underlying options.</TD></TR></TABLE>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 36pt; text-align: justify">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
  <TD STYLE="width: 0.25in"></TD><TD STYLE="width: 0.25in">(9)</TD><TD>Includes 459,200 shares of Common Stock underlying options.</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: justify; text-indent: 0.25in">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: 46; 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; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B><A NAME="b_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-align: justify; text-indent: 0.25in">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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><A NAME="b_008"></A><B>PLAN OF DISTRIBUTION</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: justify; text-indent: 0.25in">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; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR>
      <TD STYLE="padding-right: 0.9pt; text-align: justify; width: 0.25in">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.9pt; text-align: justify; width: 0.25in"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="vertical-align: top; padding-right: 1.05pt; text-align: justify"><FONT STYLE="font-size: 10pt">the persons identified in the table above as the Selling Stockholders;</FONT></TD></TR>
    <TR>
      <TD STYLE="padding-right: 0.9pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 0.9pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; text-align: justify">&nbsp;</TD></TR>
    <TR>
      <TD STYLE="padding-right: 1.1pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 1.1pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="vertical-align: top; padding-right: 1.05pt; text-align: justify"><FONT STYLE="font-size: 10pt">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</FONT></TD></TR>
    <TR>
      <TD STYLE="padding-right: 1.1pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 1.1pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 1.3pt; text-align: justify">&nbsp;</TD></TR>
    <TR>
      <TD STYLE="padding-right: 1.1pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: top; padding-right: 1.1pt; text-align: justify"><FONT STYLE="font-size: 10pt">&#9679;</FONT></TD>
      <TD STYLE="vertical-align: top; padding-right: 1.1pt; text-align: justify"><FONT STYLE="font-size: 10pt">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.</FONT></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: justify; text-indent: 0.25in">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: 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">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: 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">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: 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: justify; text-indent: 0.25in">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: justify; text-indent: 36pt; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">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.</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">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: 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">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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">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: 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">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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.25in">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-top: 0pt; margin-bottom: 0pt; text-align: center"><B><A NAME="b_009"></A>LEGAL MATTERS</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: justify; text-indent: 0.25in">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: justify"></P>
  
  <!-- Field: Page; Sequence: 48; Value: 1 -->
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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; text-align: center"><B>DISCLOSURE OF COMMISSION POSITION ON</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: 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">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: 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">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: 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">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>
  
  <!-- Field: Page; Sequence: 49; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="border-top: Black 2.5pt double; 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; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>ONCONETIX, INC.</B></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>885,796 Shares of</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Common Stock</B></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">&nbsp;</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>PROSPECTUS</B></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">&nbsp;</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">February 1, 2024</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="border-bottom: Black 2.5pt double; 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: 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: 50 -->
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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-top: 0pt; margin-bottom: 0pt; text-align: center"><B>PART II</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-top: 0pt; margin-bottom: 0pt; text-align: center"><A NAME="b_003"></A><B>INFORMATION NOT REQUIRED IN 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: justify"><B>Item 3. 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: justify; 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: justify; text-indent: 32.4pt; 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; text-align: justify">&nbsp;</TD>
      <TD STYLE="width: 0.25in; text-align: justify"><FONT STYLE="font-size: 10pt">(i)</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our Annual Report on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023018635/f10k2022_bluewater.htm">Form 10-K</A> for the fiscal year ended December 31,
      2022 as filed with the SEC on March 9, 2023;</FONT></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>&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">(ii)</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
      as filed with the SEC on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023039141/f10q0323_bluewater.htm">May 12, 2023</A>; the quarter ended June 30, 2023 as filed with the SEC on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000101376223005521/f10q0623_bluewater.htm">October 20, 2023</A>; and the quarter
      ended September 30, 2023 as filed with the SEC on <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023088387/f10q0923_bluewater.htm">November 17, 2023</A>;</FONT></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">(iii)</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">our Current Reports on Form 8-K dated <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023024177/ea175921-8k_bluewater.htm">March 29, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023031189/ea177216-8k_bluewater.htm">April 20, 2023</A>,
      <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023031827/ea177344-8k_bluewater.htm">April 24, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023046841/ea179858-8k_bluewater.htm">June 6, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023048740/ea180344-8k_bluewater.htm">June 14, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023055208/ea181447-8k_bluewater.htm">July 6, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023056042/ea181608-8k_bluewater.htm">July 11, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023059436/ea182294-8k_bluewater.htm">July 25, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023059436/ea182294-8k_bluewater.htm">July 25, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023061031/ea182603-8k_bluewater.htm">July 31, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023061642/ea182607-8k_bluewater.htm">August 1, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023062922/ea182728-8k_bluewater.htm">August 3, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023065302/ea183230-8k_bluewater.htm">August 10, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023069983/ea184059-8k_bluewater.htm">August 22, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023071247/ea184317-8k_bluewater.htm">August 28, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023075413/ea184934-8k_bluewater.htm">September 8, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023078811/ea185612-8k_bluewater.htm">September 22, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000101376223000742/ea186204-8k_bluewater.htm">October 3, 2023</A>,
      <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023081324/ea186383-8k_bluewater.htm">October 10, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023096298/ea190227-8k_onconetix.htm">December 18, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023098928/ea190756-8ka1_onconetix.htm">December 27, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390023099224/ea190830-8k_onconetix.htm">December 28, 2023</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390024003413/ea191591-8k_onconetix.htm">January 12, 2024</A>, <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390024004855/ea191886-8k_onconetix.htm">January 19, 2024</A> and <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390024007414/ea192391-8k_onconetix.htm">January 29, 2024</A>.</FONT></TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">(iv)</FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">the description of our securities registered under Section 12 of the
      Exchange Act as filed as <A HREF="http://www.sec.gov/Archives/edgar/data/1782107/000121390022016672/f10k2021ex4-2_bluewater.htm">Exhibit 4.2</A> on Annual Report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on
      March 31, 2022.</FONT></TD></TR>
    </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 32.4pt; background-color: white">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: 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">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 Bruce Harmon, c/o Onconetix, 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.onconetix.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: 0pt 0; text-align: justify"><B>Item 4. 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; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 51; Options: NewSection; 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: justify"><B>Item 5. 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"><B>Item 6. 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: justify; 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: 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">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: 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">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: 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">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"><B>Item 7. 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; 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>
  
  <!-- Field: Page; Sequence: 52; 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: justify"><B>Item 8. 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; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
    <TR>
      <TD STYLE="vertical-align: bottom; border-bottom: black 1.5pt solid; text-align: justify; width: 9%"><FONT STYLE="font-size: 10pt"><B>Number</B></FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; width: 1%">&nbsp;</TD>
      <TD STYLE="vertical-align: top; border-bottom: black 1.5pt solid; text-align: justify; width: 90%"><FONT STYLE="font-size: 10pt"><B>Description</B></FONT></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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.1</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.2</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.3</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.4</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.5</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.6</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">4.7</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><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></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">5.1</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea192581ex5-1_onconetix.htm"><FONT STYLE="font-size: 10pt">Opinion of Ellenoff Grossman &amp; Schole LLP (Filed herewith)</FONT></A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">23.1</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><A HREF="ea192581ex23-1_onconetix.htm">Consent of Mayer Hoffman McCann P.C. (Filed herewith)</A></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">23.2</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea192581ex5-1_onconetix.htm"><FONT STYLE="font-size: 10pt">Consent of Ellenoff Grossman &amp; Schole LLP (included in Exhibit 5.1)</FONT></A></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">24</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt"><A HREF="#b_010">Powers of Attorney (included on signature page)</A></FONT></TD></TR>
    <TR STYLE="vertical-align: top; background-color: white">
      <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; background-color: #CCEEFF">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">107</FONT></TD>
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><A HREF="ea192581ex-fee_onconetix.htm"><FONT STYLE="font-size: 10pt">Filing Fee Table. (Filed herewith)</FONT></A></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>Item 9. 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; text-align: left"><FONT STYLE="font-size: 10pt">(II)</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">The undersigned registrant
  hereby undertakes:</FONT></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; text-align: left"><FONT STYLE="font-size: 10pt">(II)</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">To file, during any period
  in which offers or sales are being made, a post-effective amendment to this registration statement</FONT></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; text-align: left"><FONT STYLE="font-size: 10pt">(II)</FONT></TD><TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">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.</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: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: 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: justify; 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(c), 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; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(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: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">(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; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 54; 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-top: 0pt; margin-bottom: 0pt; text-align: center"><B><A NAME="b_010"></A>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-align: justify; 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 February 1, 2024.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&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"><FONT STYLE="font-size: 10pt"><B>ONCONETIX, INC.</B></FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify; width: 60%">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 4%">&nbsp;</TD>
      <TD STYLE="text-align: justify; width: 36%">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
      <TD STYLE="border-bottom: black 1.5pt solid; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ Dr. Ralph Schiess</FONT></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"><FONT STYLE="font-size: 10pt">Dr. Ralph Schiess</FONT></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"><FONT STYLE="font-size: 10pt">Interim Chief Executive Officer</FONT></TD></TR>
    </TABLE>
  <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-top: 0pt; margin-bottom: 0pt; text-align: center; background-color: white"><B>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: justify; text-indent: 0.25in"><B>KNOW ALL MEN BY THESE PRESENTS</B>,
  that we, the undersigned officers and directors of Onconetix, Inc., a Delaware corporation, do hereby constitute and appoint Dr. Ralph
  Schiess 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.</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 24pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; 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-align: justify; 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: 28%; border-bottom: black 1.5pt solid; padding-right: 3pt; text-align: justify"><FONT STYLE="font-size: 10pt"><B>Name</B></FONT></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 47%; text-align: center"><FONT STYLE="font-size: 10pt"><B>Position</B></FONT></TD>
      <TD STYLE="white-space: nowrap; width: 1%; padding-bottom: 1.5pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="border-bottom: black 1.5pt solid; width: 23%; 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; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ Dr. Ralph Schiess</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Interim Chief Executive Officer</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">February 1, 2024</FONT></TD></TR>
    <TR>
      <TD STYLE="vertical-align: top; text-align: justify"><FONT STYLE="font-size: 10pt">Dr. Ralph Schiess</FONT></TD>
      <TD STYLE="white-space: nowrap; vertical-align: top; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; text-align: justify"><FONT STYLE="font-size: 10pt">(Principal Executive Officer)</FONT></TD>
      <TD STYLE="white-space: nowrap; vertical-align: bottom; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="vertical-align: bottom; padding-bottom: 2.25pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ Bruce Harmon</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Chief Financial Officer </FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">February 1, 2024</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt; background-color: white">Bruce Harmon</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: justify"><FONT STYLE="font-size: 10pt">&nbsp;(Principal Financial Officer)</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ James Sapirstein</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Non-Executive Chairman of the Board </FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">February 1, 2024</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">James Sapirstein </FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ Timothy Ramdeen</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">February 1, 2024</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Timothy Ramdeen</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: center">&nbsp;</TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="border-bottom: black 1.5pt solid; padding-top: 8pt; text-align: justify"><FONT STYLE="font-size: 10pt">/s/ Simon Tarsh</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Director</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">February 1, 2024</FONT></TD></TR>
    <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: justify"><FONT STYLE="font-size: 10pt">Simon Tarsh</FONT></TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="white-space: nowrap; padding-bottom: 2.25pt; text-align: justify">&nbsp;</TD>
      <TD STYLE="padding-bottom: 2.25pt; text-align: center">&nbsp;</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">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center">II-5</P>
  
  <!-- Field: Rule-Page --><DIV STYLE="margin-top: 0pt; margin-bottom: 0pt; width: 100%"><DIV STYLE="font-size: 1pt; border-top: Black 1.5pt solid">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"></P>
  
  </BODY>
  </HTML>
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metadata_filer: {"company-data": {"conformed-name": "Onconetix, Inc.", "cik": "0001782107", "assigned-sic": "2834", "organization-name": "03 Life Sciences", "irs-number": "000000000", "state-of-incorporation": "DE", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "S-8", "act": "33", "file-number": "333-276824", "film-number": "24587843"}, "business-address": {"street1": "201 E. FIFTH STREET", "street2": "SUITE 1900", "city": "CINCINNATI", "state": "OH", "zip": "45202", "phone": "513-620-4101"}, "mail-address": {"street1": "201 E. FIFTH STREET", "street2": "SUITE 1900", "city": "CINCINNATI", "state": "OH", "zip": "45202"}, "former-company": [{"former-conformed-name": "Blue Water Biotech, Inc.", "date-changed": "20230424"}, {"former-conformed-name": "Blue Water Vaccines Inc.", "date-changed": "20190710"}]}
text: As filed with the Securities and Exchange Commission
  on February 1, 2024
  Registration No. 333-______________
  UNITED STATES
  SECURITIES AND EXCHANGE COMMISSION
  Washington, D.C. 20549
  FORM S-8
  REGISTRATION STATEMENT UNDER THE SECURITIES
  ACT OF 1933
  Onconetix, 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)
  Onconetix, Inc. 2019 Equity Incentive Plan
  Onconetix, Inc. 2022 Equity Incentive Plan
  (Full Title of the Plan)
  Dr. Ralph Schiess
  Interim Chief Executive Officer
  Onconetix, 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
  Onconetix, Inc. (the "Registrant"
  or the "Company") is filing this registration statement on Form S-8 under the Company's 2019 Equity Incentive Plan (the
  "2019 Plan") and the 2022 Equity Incentive Plan (the "2022 Plan") to (i) register 550,000 shares of our common
  stock, par value $0.00001 per share (the "Common Stock"), to be issued pursuant to the 2022 Plan, as described in more detail
  herein, (ii) register for resale pursuant to a reoffer prospectus 885,796 shares of Common Stock issued to our executive officers and
  directors or to be issued to such officers and directors upon exercise of outstanding options or vesting of outstanding restricted stock
  units as described below, and (iii) serve as a post-effective amendment, pursuant to Rule 429 under the Securities Act of 1933, as amended
  (the "Securities Act"), to our Registration Statement on Form S-8 (File No. 333-265843) filed with the Securities and Exchange
  Commission ("SEC") on June 27, 2022 as amended by the Registration Statement on Form S-8 (File No. 333-268357) filed with
  the SEC on November 14, 2022 (the "Prior Registration Statement").
  Pursuant to General Instruction
  E to Form S-8, the contents of the Prior Registration Statement is incorporated herein by reference, except to the extent supplemented,
  amended or superseded by the information set forth in this registration statement on Form S-8.
  This Registration Statement
  includes, pursuant to General Instruction E 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 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 885,796 Common Shares
  issued or to be issued under the 2019 and the 2022 Plan. These shares constitute "control securities" or "restricted
  securities" which have been issued prior to or issuable after the filing of this Registration Statement. The Reoffer Prospectus
  does not contain all of the information included in the Registration Statement, certain items of which are contained in schedules and
  exhibits to the Registration Statement, as permitted by the rules and regulations of the SEC. Statements contained in the Reoffer Prospectus
  as to the contents of any agreement, instrument or other document referred to are not necessarily complete. With respect to each such
  agreement, instrument or other document filed as an exhibit to the Registration Statement, we refer you to the exhibit for a more complete
  description of the matter involved, and each such statement shall be deemed qualified in its entirety by this reference.
  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
  Item 1. Plan Information.*
  Item 2. Registrant Information and Employee
  Plan Annual Information.*
  *
  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 of 1934, as amended (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
  Onconetix, Inc.
  Up to 885,796 shares
  of Common Stock under the 2019 Equity Incentive Plan and 2022 Equity Incentive Plan
  This
  prospectus relates to the resale of up to 885,796 shares (the "Shares") of common stock, par value $0.00001 per share (the
  "Common Stock"), of Onconetix, 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 40 of this prospectus.
  Our Common Stock is listed on The Nasdaq Capital Market under the symbol "ONCO." On January 30, 2024, the closing price of
  the Common Stock on The Nasdaq Capital Market was $0.207 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
  $0.146 on January 24, 2024 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 various announcements regarding certain
  research developments, agreements, acquisitions, a shift in business strategy to focus on oncology, changes in management and other matters.
  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 33 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 33 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 February 1, 2024.
  TABLE OF CONTENTS
  Page No
  Where You Can Find More Information
  ii
  Prospectus Summary
  1
  Incorporation of Certain Documents By Reference
  II-1
  Note on Forward Looking Statements
  15
  The Company
  Risk Factors
  34
  Selling Stockholders
  41
  Use of Proceeds
  42
  Plan of Distribution
  42
  Legal Matters
  43
  Experts
  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 commercial stage biotechnology company
  focused on the research, development, and commercialization of innovative solutions for oncology. We own ENTADFI, an FDA-approved, once
  daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia ("BPH"), a disorder of
  the prostate, and Proclarix, a European CE IVD approval for prostate diagnostics and a lab developed test currently in the U.S., originally
  developed by Proteomedix.
  ENTADFI allows men to receive treatment for their
  symptoms of BPH without the negative sexual side effects typically seen in patients on finasteride alone. Following a recent business
  strategy shift towards the field of oncology and deprioritization of preclinical vaccine programs, we are building additional assets in
  therapeutics, diagnostics, and clinician services for oncology. ENTADFI will become the inaugural therapeutic drug in the Company's
  expanding portfolio of oncology therapeutics once launched.
  Proclarix is an easy-to-use next generation protein-based
  blood test that can be done with the same sample as a patient's regular Prostate-Specific Antigen ("PSA") test. The
  PSA test is a well-established prostate specific marker that measures the concentration of PSA molecules in a blood sample. A high level
  of PSA can be a sign of prostate cancer. However, PSA levels can also be elevated for many other reasons including infections, prostate
  stimulation, vigorous exercise or even certain medications. PSA results can be confusing for many patients and even physicians. It is
  estimated over 50% of biopsies with elevated PSA are negative or clinically insignificant resulting in an overdiagnosis and overtreatment
  that impacts the physician's routine, our healthcare system, and the quality of patients' lives. Proclarix helps doctors and
  patients with unclear PSA test results through the use of our proprietary Proclarix Risk Score which delivers clear and immediate diagnostic
  support for further treatment decisions. No additional intervention is required and results are available quickly. Local diagnostic laboratories
  can easily add this affordable multiparametric test to their existing infrastructure.
  Prior to the acquisition of ENTADFI, we managed one distinct business
  segment, which was research and development. Beginning in the second quarter of 2023, as a result of the acquisition of ENTADFI, for which
  we are working towards commercial launch, we operated in two business segments: research and development and commercial. During the third
  quarter of 2023, we deprioritized our vaccine discovery and development programs, and accordingly, we now operate in one segment: commercial.
  Our recent acquisition of Proteomedix during the fourth quarter of 2023 and its related diagnostic product Proclarix was determined to
  be within our commercial segment. The research and development segment was our historical business, and was dedicated to the research
  and development of various vaccines to prevent infectious diseases. The commercial segment was new in the second quarter of 2023 and is
  dedicated to the commercialization of our FDA-approved products, namely ENTADFI and Proclarix.
  1
  Recent key developments affecting our business
  include:
  ●
  Announced Shift in Business Strategy to Focus on the Field of Oncology:
  On October 30, 2023, in a letter to shareholders, former President and CEO, Dr. Neil Campbell, announced that the Company intends to shift its focus toward building a foundation of therapeutic, diagnostic, and service products in the field of oncology. The Company's previous activities in acquiring assets from WraSer and Xspire Pharma, including certain commercial relationships intended for the marketing and sale of these assets, were reassessed and it was decided that they would not align with the new shift towards oncology. Additionally, the Company conducted a strategic and tactical assessment of its preclinical vaccine programs and, considering the immense amount of time and resources needed to pursue these programs as well as evolving market dynamics, these programs have been deprioritized. The Company believes that the strategic shift in business strategy towards the field of oncology, as well as pursuing the launch of ENTADFI in 2024, will enhance shareholder value and enable the Company to provide leading-edge therapeutics, diagnostics, and services to clinicians, patients, and caregivers.
  ●
  Acquired a Commercial Stage Oncology Company:
  On December 15, 2023, the Company closed its acquisition of Proteomedix AG, a private, commercial-stage diagnostics oncology company ("Proteomedix"), and introduced Onconetix, Inc. as a new name for the combined Company. The closing of the acquisition of Proteomedix for all stock consideration (the "Closing") provides Proteomedix shareholders with an initial 19.9% ownership stake of Onconetix, and Series B preferred stock convertible into 269,672,900 additional common shares of Onconetix subject to Onconetix shareholder approval of the same.
  ●
  Signed Various Agreements to Support the Commercial Launch of ENTADFI:
  Throughout the third quarter of 2023, the Company signed several agreements and established key relationships to support the commercial launch of ENTADFI. These agreements include the following:
  ●
  Marketing and Advertising Support:
  In July 2023, the Company signed a Master Services Agreement with bfw Advertising Inc. ("bfw") to generate marketing and advertising material for Onconetix's commercial stage drug portfolio. Bfw will work with Onconetix's commercial team to increase awareness for its commercial products through patient-facing materials, website updates, social ads, targeted provider engagement, as well as materials to support Onconetix's sales team, among other services.
  ●
  Healthcare Payer Coverage Support:
  In July 2023, Onconetix signed an agreement with Advantage Point Solutions, LLC ("APS") to support Onconetix's market access strategy for its commercial pharmaceutical portfolio. APS will support market access for ENTADFI, including assistance in formulary negotiations with key healthcare payers and pharmacy benefit managers in the commercial and government sectors. With its robust network of relationships, APS helps commercial stage pharmaceutical companies build long-term relationships with payers with the goal of maximizing access and reimbursement for approved pharmaceutical products. APS also has decades of experience advising companies on product launches across a broad spectrum of therapeutic areas.
  ●
  Telemedicine Channel:
  In July 2023, Onconetix signed an agreement with UpScriptHealth to generate a robust, online telemedicine platform to distribute ENTADFI. Through this platform, UpScriptHealth will help support patients with benign prostatic hyperplasia throughout the prescription and coverage process, as well as provide eligible patients access to ENTADFI
  mailed directly to their homes.
  ●
  Entered into Distribution Agreement
  : On September 21, 2023, the Company entered into an Exclusive Distribution Agreement to engage Cardinal Health 105, LLC as its exclusive third-party logistics distribution agent for sales of all of the Company's commercial assets.
  ●
  Granted Pharmaceutical Wholesaler License in Ohio and Tennessee:
  The Ohio State Board of Pharmacy and the Tennessee State Board of Pharmacy, in July 2023 and September 2023, respectively, granted Onconetix a license to operate as a pharmaceutical wholesaler. These licenses allow Onconetix to conduct business in the States of Ohio and Tennessee.
  Since our inception in October 2018 until April
  2023, when we acquired ENTADFI, we 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, acquiring and developing
  our technology and now deprioritized vaccine candidates, organizing and staffing our company, performing business planning, establishing
  our intellectual property portfolio and raising capital to support and expand such activities.
  We are currently focusing our efforts on (i) building
  out our commercial capabilities to launch ENTADFI in the marketplace and (ii) commercializing Proclarix.
  2
  Given ENTADFI and Proclarix are currently
  FDA-approved, we expect to generate revenue from sales of ENTADFI and Proclarix in the near term. Although we anticipate these sales
  to offset some expenses relating to commercial scale up and development, we expect our expenses will increase substantially in connection
  with our ongoing activities, as we:
  ●
  Commercialize and/
  or
  launch ENTADFI and Proclarix, and other commercial-stage products,
  ●
  hire additional personnel;
  ●
  operate as a public company, and;
  ●
  obtain, maintain, expand and protect our intellectual property portfolio.
  We rely and will continue to rely on third parties
  for the manufacturing of ENTADFI and Proclarix. We have no internal manufacturing capabilities, and we will continue to rely on third
  parties, of which the main suppliers are single-source suppliers, for commercial products.
  As we have a product in commercial stage, we are
  seeking to build a robust and efficient commercial team to accommodate this development. This includes appropriate personnel and third-party
  relationships and contracts to execute our commercialization strategy. We also expect to incur significant commercialization expenses
  related to marketing, manufacturing and distribution for those products.
  We do not have any products approved for sale,
  aside from ENTADFI, which we have not generated any revenue from product sales from, and Proclarix, which we have generated only minimal
  amounts of revenue from since its acquisition. To date, we have financed our operations primarily with proceeds from our sale of preferred
  securities to seed investors, the close of the IPO, the close of the 2022 Private Placements, the proceeds received from a warrant exercise
  in August 2023, and the proceeds received from the issuance of debt in January 2024. We will continue to require significant additional
  capital to commercialize ENTADFI and Proclarix and fund operations for the foreseeable future. Accordingly, until such time as we
  can generate significant revenue, if ever, we expect to finance our cash needs through public or private equity or debt financings, third-party
  (including government) funding and to rely on third-party resources for marketing and distribution arrangements, as well as other collaborations,
  strategic alliances and licensing arrangements, or any combination of these approaches, to support our operations.
  We have incurred net losses since inception and
  expect to continue to incur net losses in the foreseeable future. Our net losses may fluctuate significantly from quarter-to-quarter and
  year-to-year, depending in large part on the timing of our preclinical studies, clinical trials and manufacturing activities, our expenditures
  on other research and development activities and commercialization activities. As of September 30, 2023, the Company had a working capital
  deficit of approximately $8.1 million and an accumulated deficit of approximately $34.4 million. We will need to raise additional capital
  within the next 12 months to sustain operations. In addition, if Stockholder Approval is not obtained by January 1,
  2025, the Company may be obligated to cash settle the Series B Convertible Preferred Stock.
  Until we generate revenue
  sufficient to support self-sustaining cash flows, if ever, we will need to raise additional capital to fund our continued
  operations, including our product development and commercialization activities related to our current and future products. There can
  be no assurance that additional capital will be available to us on acceptable terms, or at all, or that we will ever generate
  revenue sufficient to provide for self-sustaining cash flows. These circumstances raise substantial doubt about our ability to
  continue as a going concern. The September 30, 2023 condensed financial statements incorporated by reference in this Registration
  Statement do not include any adjustment that might be necessary if the Company is unable to continue as a going concern.
  Because of the numerous risks and uncertainties
  associated with our business, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve
  or maintain profitability. Additionally, even if we are able to generate revenue from ENTADFI or Proclarix, we may not become profitable.
  If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations
  at planned levels and may be forced to reduce our operations.
  3
  Management and Board Changes
  Effective as of August 16, 2023, Joseph Hernandez
  resigned as Chairman, Chief Executive Officer, and a member of the Board of Directors (the "Board") of the Company.
  Effective August 16, 2023, the Board appointed
  Jon Garfield, the Company's former Chief Financial Officer, to serve as the Company's interim principal executive officer.
  Effective as of October 4, 2023, Jon Garfield resigned as Chief Financial Officer and interim principal executive officer of the Company.
  The Company and Mr. Garfield entered into a separation agreement, which provided for two months of severance payment.
  Effective as of September 2, 2023, Vuk Jeremic
  resigned as a member of the Board of the Company as well as from his positions as a member of the Compensation Committee and Nominating
  and Corporate Governance Committee of the Board. Mr. Jeremic's departure was not the result of any disagreement with management
  or the Board on any matter relating to the Company's operations, policies or practices.
  On October 4, 2023 (the "Effective Date"),
  the Company appointed Dr. Neil Campbell, 63, as President and Chief Executive Officer of the Company and as a member of the Board of Directors
  (the "Board") of the Company.
  In connection with Dr.
  Campbell's appointment, the Company and Dr. Campbell entered into an employment agreement (the "Campbell Employment
  Agreement"), pursuant to which Dr. Campbell would serve as President and Chief Executive Officer of the Company and was
  paid a signing bonus of $75,000 and an annual base salary of $475,000. Pursuant to the Campbell Employment Agreement, Dr.
  Campbell was granted a long-term equity incentive grant in the form of an option to purchase 532,326 shares of the
  Company's common stock. Such award was to vest in quarterly increments over a period of three years, subject to Dr.
  Campbell's continued employment by the Company on the applicable vesting date. Dr. Campbell's option grant has an
  exercise price per share equal to $0.4305, which was the closing price of the Company's common stock on Nasdaq on the grant
  date.
  On October 4, 2023, the Company also appointed
  Bruce Harmon, 65, as Chief Financial Officer of the Company, effective immediately.
  In connection with Mr. Harmon's appointment,
  the Company and Mr. Harmon entered into an employment agreement (the "Harmon Employment Agreement"), pursuant to which Mr. Harmon will
  serve as Chief Financial Officer of the Company and will be paid an annual base salary of $325,000. In addition, Mr. Harmon is
  entitled to receive, subject to employment by the Company on the applicable date of bonus payout, an annual target discretionary bonus
  of up to 30% of his annual base salary, payable at the discretion of the Compensation Committee of the Board. Pursuant to the Harmon Employment
  Agreement, Mr. Harmon is also eligible to receive healthcare benefits as may be provided from time to time by the Company to
  its employees generally, and to receive paid time off annually. Pursuant to the Harmon Employment Agreement, Mr. Harmon was
  granted a long-term equity incentive grant in the form of an option to purchase 177,442 shares of the Company's common stock. Such
  award vests in quarterly increments over a period of three years, subject to Mr. Harmon's continued employment by the Company
  on the applicable vesting date. Mr. Harmon's option grant has an exercise price per share equal to $0.4305, which was the closing
  price of the Company's common stock on Nasdaq on the grant date.
  In connection with the acquisition of Proteomedix,
  Christian Brühlmann was appointed as Chief Strategy Officer and Dr. Ralph Schiess was appointed as Chief Science Officer. Mr. Brühlmann
  co-founded Proteomedix and served as its Chief Financial and Operations Officer from March 2010 until November 2018. Beginning in December
  2018, Mr. Brühlmann served as Proteomedix's Chief Business Officer until the consummation of the Closing. Dr. Schiess co-founded
  Proteomedix in March 2010 and served as its Chief Executive Officer from its inception until December 2019. Dr. Schiess then served as
  Proteomedix's Chief Scientific Officer from January 2020 to May 2023. Dr. Schiess returned to his role as Chief Executive Officer
  in June 2023 and served until the consummation of the Closing.
  On and effective December 21, 2023, Erin Henderson
  resigned as Chief Business Officer to pursue other opportunities. On January 17, 2024, the Company entered into a Separation Agreement
  and General Release with Ms. Henderson, pursuant to which the Company agreed to engage The Aetos Group, a management consulting company
  founded and managed by Ms. Henderson ("Aetos"), to perform certain consulting services for the Company. On January 17, 2024,
  the Company entered into a Consulting Agreement with Aetos, pursuant to which Aetos will provide consulting services to the Company until
  April 25, 2024 and receive a monthly fee of approximately $27,083.
  4
  On and effective January 10, 2024, Dr. Neil Campbell
  resigned as Chief Executive Officer, President and Director. The Company entered into a Release of Claims with Dr. Campbell, pursuant
  to which Dr. Campbell will receive a one-time severance payment of $158,333. On January 12, 2024, the Board appointed Dr. Ralph Schiess,
  the Company's Chief Science Officer, to serve as the Company's Interim Chief Executive Officer. As Interim Chief Executive
  Officer, Dr. Schiess shall have general supervision and direction of the business and affairs of the Company.
  Recent Acquisitions:
  Proteomedix
  On December 15, 2023, Onconetix entered into a
  Share Exchange Agreement (the "Share Exchange Agreement"), by and among (i) Onconetix, (ii) Proteomedix (iii) each of the
  holders of outstanding capital stock or Proteomedix Convertible Securities (other than Proteomedix Stock Options) named therein (collectively,
  the "Sellers") and (iv) Thomas Meier, in the capacity as the representative of Sellers in accordance with the terms and conditions
  of the Share Exchange Agreement (the "Sellers' Representative").
  Pursuant to the Share Exchange Agreement,
  subject to the terms and conditions set forth therein, the Sellers agreed to sell to Onconetix, and Onconetix agreed to buy, all
  of the issued and outstanding equity interests of Proteomedix (the "Purchased Shares") in exchange for newly issued shares
  of common stock of Onconetix, par value $0.00001 per share ("Buyer Common Stock"), and newly issued shares of preferred stock
  of Onconetix, par value $0.00001 per share ("Series B Convertible Preferred Stock"), as further described below (the "Share
  Exchange" and the other transactions contemplated by the Share Exchange Agreement, the "Transactions").
  The consummation (the "Closing")
  of the Share Exchange was subject to customary closing conditions and the execution of the Subscription Agreement (as defined below) entered
  into with an investor (the "Investor"). The Share Exchange closed on December 15, 2023 (the "Closing Date").
  Consideration
  In full payment for the Purchased Shares, Onconetix
  issued shares (the "Exchange Shares") consisting of: (i) 3,675,414 shares of Buyer Common Stock equal to approximately 19.9%
  of the total issued and outstanding Buyer Common Stock and (ii) 2,696,729 shares of Series B Convertible Preferred Stock convertible into
  269,672,900 shares of Buyer Common Stock. The aggregate value of the Exchange Shares at Closing was equal to approximately Seventy-Five
  Million U.S. Dollars ($75,000,000) (the "Exchange Consideration") less the value of the Proteomedix Shares for which the Proteomedix
  Stock Options are exercisable immediately prior to the Closing, subject to adjustment for indemnification as described below.
  Tungsten Advisors acted as financial advisor to
  Proteomedix. As part of compensation for services rendered by Tungsten Advisors, $7,500,000 in Exchange Shares was issued to certain affiliates
  of Tungsten Advisors (the "Advisor Parties") out of the total Exchange Consideration issued by Onconetix.
  As a result of the Transactions, Proteomedix became
  a direct, wholly-owned subsidiary of Onconetix. It is anticipated that, following the Conversion (as defined below) and closing of the
  investment pursuant to the Subscription Agreement (as defined below), Sellers will own 79.8% of the outstanding equity interests of Onconetix,
  the Investor will own 5.9% of the outstanding equity interests of Onconetix, and the stockholders of Buyer immediately prior to the Closing
  will own 5.4% of the outstanding equity interests of Onconetix.
  5
  Each option to purchase shares of Proteomedix
  (each, a "Proteomedix Stock Option") outstanding immediately before the Closing, whether vested or unvested, remains outstanding
  until the Conversion unless otherwise terminated in accordance with its terms. At the Conversion, each outstanding Proteomedix Stock Option,
  whether vested unvested, shall be assumed by Onconetix and converted into the right to receive (a) an option to acquire shares of Buyer
  Common Stock (each, an "Assumed Option") or (b) such other derivative security as Onconetix and Proteomedix may agree, subject
  in either case to substantially the same terms and conditions as were applicable to such Proteomedix Stock Option immediately before the
  Closing. Each Assumed Option shall: (i) represent the right to acquire a number of shares of Buyer Common Stock equal to the product of
  (A) the number of Proteomedix Common Shares that were subject to the corresponding Proteomedix Option immediately prior to the Closing,
  multiplied by (B) the Exchange Ratio; and (ii) have an exercise price (as rounded down to the nearest whole cent) equal to the quotient
  of (A) the exercise price of the corresponding Proteomedix Option, divided by (B) the Exchange Ratio.
  Indemnification
  . Until the earlier of (i)
  Stockholder Approval or (ii) June 30, 2024 (the "Claim Deadline"), Onconetix may assert Claims against Proteomedix and Sellers
  for any and all Losses incurred by Onconetix with respect to: (i) any inaccuracy in or breach of any of the representations or warranties
  made by Proteomedix contained in the Share Exchange Agreement or (ii) any breach or non-fulfillment of any covenant, agreement or obligation
  to be performed by Proteomedix pursuant to the Share Exchange Agreement. Until the Claim Deadline, the Sellers' Representative,
  acting on behalf of the Sellers, may assert Claims against Onconetix for any Loss incurred by the Sellers with respect to: (i) any inaccuracy
  in or breach of any of the representations or warranties of Onconetix contained in the Share Exchange Agreement or (ii) any breach or
  non-fulfillment of any covenant, agreement or obligation to be performed by Onconetix pursuant to the Share Exchange Agreement.
  The number of shares of Buyer Common Stock issued
  upon Conversion shall be increased or decreased by a number determined by dividing the Net Adjustment by the ten-day volume-weighted average
  price ("VWAP") of the Buyer Common Stock for the ten (10)-day period preceding the third day prior to the Closing Date and
  rounding down to the nearest whole share; provided, however, that (i) there shall be no adjustment to the number of shares of Buyer Common
  Stock issued upon Conversion if the Net Adjustment is less than $1,000,000 and (ii) the number of shares of Buyer Common Stock issued
  upon Conversion shall not be increased or decreased by more than 10% of the number of shares of Buyer Common Stock that would be issuable
  absent such adjustment. As used herein, "Net Adjustment" means the absolute value of the difference between the aggregate
  adjustment in favor of each party with respect to Losses that is agreed by Buyer and the Sellers' Representative or determined by
  a mutually acceptable dispute resolution firm.
  From and after the Closing and until the first
  anniversary of the Closing, Sellers, severally and not jointly, are required to indemnify Onconetix and its affiliates and their respective
  representatives (collectively, the "Buyer Indemnitees") against (i) any inaccuracy in or breach of any of the representations
  or warranties of such Seller contained in the Share Exchange Agreement and (ii) breach or non-fulfillment of any covenant, agreement or
  obligation to be performed by such Seller pursuant to the Share Exchange Agreement. Any payment due from any Seller in respect of an indemnification
  claim by any Buyer Indemnitee shall solely be satisfied by recourse to the Exchange Shares and the shares of Buyer Common Stock issuable
  upon the Conversion, with each share of Buyer Common Stock valued at the same price per share of Buyer Common Stock used to determine
  the Exchange Ratio.
  Shareholder Approval
  The issuance of the Conversion Shares, amendment
  of Onconetix's certificate of incorporation to authorize sufficient additional shares of Buyer Common Stock to permit the Conversion
  and the appointment of certain individuals to the Board requires the approval of Onconetix's stockholders. Onconetix agreed to prepare
  and file with the Securities and Exchange Commission ("SEC") a proxy statement (a "Proxy Statement") for the purpose
  of soliciting proxies from the stockholders of Onconetix for the matters to be acted on at the special meeting of the stockholders of
  Onconetix. Onconetix also agreed to prepare a registration statement on Form S-1 or Form S-4 in connection with the registration under
  the Securities Act of 1933, as amended (the "Securities Act"), of the issuance of Buyer Securities to be issued under the
  Share Exchange Agreement and containing a Proxy Statement.
  6
  Series B Convertible Preferred Stock
  Upon Stockholder Approval, each share of Series
  B Convertible Preferred Stock shall automatically convert into 100 shares of Buyer Common Stock in accordance with the terms of the Certificate
  of Designation (the "Conversion"), a copy of which is attached hereto as Exhibit 4.1. If Stockholder Approval is not obtained
  by January 1, 2025, Onconetix shall be obligated to cash settle the Series B Convertible Preferred Stock, as described below. The terms
  of the Series B Convertible Preferred Stock, as described in the Certificate of Designation, are as follows:
  Voting
  . The shares of Series
  B Convertible Preferred Stock carry no voting rights except: (i) with respect to the election of the Proteomedix Director (as described
  below) and (ii) that the affirmative vote of the holders of a majority of the outstanding shares of Series B Convertible Preferred
  Stock (the "Majority Holders"), acting as a single class, shall be necessary to (A) alter or change adversely the powers,
  preferences or rights given to the Series B Convertible Preferred Stock, (B) alter or amend the Certificate of Designation, or amend or
  repeal any provision of, or add any provision to, Onconetix's certificate of incorporation or bylaws, if such action would adversely
  alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series B Convertible Preferred
  Stock, (C) issue further shares of Series B Convertible Preferred Stock or increase or decrease (other than by conversion) the number
  of authorized shares of Series B Convertible Preferred Stock, or (D) authorize or create any class or series of stock, or issue shares
  of any class or series of stock, that has powers, preferences or rights senior to the Series B Convertible Preferred Stock
  Proteomedix Director
  . The Majority
  Holders, voting exclusively and as a separate class, shall be entitled to elect one (1) director of Onconetix. Any director elected as
  provided in the preceding sentence may be removed without cause by, and only by, the affirmative vote of the holders of the Series B Convertible
  Preferred Stock. If the holders of Series B Convertible Preferred Stock fail to elect a director, then any directorship not so filled
  shall remain vacant until such time as the holders of the Series B Convertible Preferred Stock elect a person to fill such directorship;
  and no such directorship may be filled by stockholders of Onconetix other than by the holders of Series B Convertible Preferred Stock.
  At any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the outstanding
  shares of Series B Convertible Preferred Stock shall constitute a quorum for the purpose of electing such director.
  Redemption
  . The shares of Series B Convertible
  Preferred Stock are not redeemable by Onconetix.
  Liquidation Preference.
  Upon a liquidation,
  dissolution or winding-up of Onconetix, whether voluntary or involuntary (a "Liquidation"), the holders of Series B Convertible
  Preferred Stock shall be entitled to receive out of the assets, whether capital or surplus, of Onconetix the same amount that a holder
  of Buyer Common Stock would receive if such Holder's Series B Convertible Preferred Stock were fully converted to Buyer Common Stock
  at the Conversion Ratio (as defined below) plus an additional amount equal to any dividends declared but unpaid to such shares, which
  amounts shall be paid
  pari passu
  with all holders of Buyer Common Stock.
  Dividends
  . The holders of the Series B
  Convertible Preferred Stock shall be entitled to receive, dividends on shares of Series B Convertible Preferred Stock (on an as-if-converted-to-common-stock
  basis) equal to and in the same form, and in the same manner, as dividends (other than dividends on shares of the Buyer Common Stock payable
  in the form of Buyer Common Stock) actually paid on shares of the Buyer Common Stock when, as and if such dividends (other than dividends
  payable in the form of Buyer Common Stock) are paid on shares of the Buyer Common Stock.
  Conversion.
  Following Stockholder Approval,
  each share of Series B Convertible Preferred Stock shall be converted into shares of Buyer Common Stock (the "Conversion Shares")
  at a ratio of 100 Conversion Shares for each share of Series B Convertible Preferred Stock (the "Conversion Ratio"). All shares
  of Series B Convertible Preferred Stock shall automatically and without any further action required be converted into Conversion Shares
  at the Conversion Ratio upon the latest date on which (i) Onconetix has received the Stockholder Approval with respect to the issuance
  of all of the shares of Buyer Common Stock issuable upon Conversion in excess of 20% of the issued and outstanding Buyer Common Stock
  on the Closing Date and (ii) Onconetix has effected an increase in the number of shares of Buyer Common Stock authorized under its certificate
  of incorporation, to the extent required to consummate the Transactions.
  7
  Cash Settlement
  . If, at any time after
  the earlier of the date of the Stockholder Approval or January 1, 2025 (the earliest such date, the "Cash Settlement Date"),
  Onconetix (x) has obtained the Stockholder Approval but fails to or has failed to deliver to a holder certificate or certificates
  representing the Conversion Shares, or deliver documentation of book entry form of (or cause its transfer agent to electronically deliver
  such evidence) Conversion Shares on or prior to the fifth business day after the date of the Stockholder Approval, or (y) has failed
  to obtain the Stockholder Approval, Onconetix shall, in either case, at the request of the holder setting forth such holder's request
  to cash settle a number of shares of Series B Convertible Preferred Stock, pay to such holder an amount in cash equal to (i) the Fair
  Value (as defined below) of the shares of Series B Convertible Preferred Stock set forth in such request multiplied by (ii) the Conversion
  Ratio in effect on the trading day on which the request is delivered to Onconetix, with such payment to be made within two (2) business
  days from the date of the request by the holder, whereupon, after payment in full thereon by Onconetix, Onconetix's obligations
  to deliver such shares underlying the request shall be extinguished. "Fair Value" of shares shall be fixed with reference
  to the last reported closing stock price on the principal trading market of the Buyer Common Stock on which the Buyer Common Stock is
  listed as of the trading day on which the request is delivered to Onconetix.
  Certain Adjustments
  . If Onconetix,
  at any time while the Series B Convertible Preferred Stock is outstanding: (A) pays a stock dividend or otherwise makes a distribution
  or distributions payable in shares of Buyer Common Stock; (B) subdivides outstanding shares of Buyer Common Stock into a larger number
  of shares; or (C) combines (including by way of a reverse stock split) outstanding shares of Buyer Common Stock into a smaller number
  of shares, then the Conversion Ratio shall be multiplied by a fraction of which the numerator shall be the number of shares of Buyer Common
  Stock outstanding immediately after such event and of which the denominator shall be the number of shares of Buyer Common Stock outstanding
  immediately before such event (excluding any treasury shares of the Corporation). If, at any time while the Series B Convertible
  Preferred Stock is outstanding, either (A) Onconetix effects any merger or consolidation of Onconetix with or into another person or any
  stock sale to, or other business combination with or into another person (other than such a transaction in which Onconetix is the surviving
  or continuing entity and holds at least a majority of the Buyer Common Stock after giving effect to the transaction and its Buyer Common
  Stock is not exchanged for or converted into other securities, cash or property), (B) Onconetix effects any sale, lease, transfer or exclusive
  license of all or substantially all of its assets in one transaction or a series of related transactions, (C) any tender offer or
  exchange offer (whether by Onconetix or another person) is completed pursuant to which more than 50% of the Buyer Common Stock not held
  by Onconetix or such person is exchanged for or converted into other securities, cash or property, or (D) Onconetix effects any reclassification
  of the Buyer Common Stock or any compulsory share exchange pursuant to which the Buyer Common Stock is effectively converted into or exchanged
  for other securities, cash or property (in any such case, a "Fundamental Transaction"), then, in connection with such Fundamental
  Transaction, the holders of Series B Convertible Preferred Stock shall receive in the Fundamental Transaction, the same kind and amount
  of securities, cash or property that a holder of Buyer Common Stock would receive if such holder's Series B Convertible Preferred
  Stock were fully converted to Buyer Common Stock, plus an additional amount equal to any dividends declared but unpaid to such shares,
  which amounts shall be paid pari passu with all holders of Buyer Common Stock in the Fundamental Transaction (the "Alternate
  Consideration"). If holders of Buyer Common Stock are given any choice as to the securities, cash or property to be received
  in a Fundamental Transaction, then the holders of Series B Convertible Preferred Stock shall be given the same choice as to the Alternate
  Consideration it receives in such Fundamental Transaction.
  Stockholder Subscription Agreement and Debenture
  In connection with the Transactions, on December
  15, 2023, Onconetix entered into a Subscription Agreement (the "Subscription Agreement") with the Investor for a private placement
  of $5.0 million of units (the "Units"), each unit comprised of (i) one share of Common Stock and (ii) one pre-funded warrant
  (collectively, the "Warrants") to purchase 0.3 shares of Common Stock at an exercise price of $0.001 per share, for an aggregate
  purchase price per Unit of $0.25 (the "Purchase Price"). Additional shares are issuable to the Investor to the extent the
  Investor continues to hold Common Stock included in the Units and if the VWAP during the 270 days following closing is less than the Purchase
  Price, as set forth in the Subscription Agreement.
  The offering is expected to close following stockholder
  approval of the issuance of the Conversion Shares. Within 30 days after closing, Onconetix will file a resale registration statement with
  the SEC registering the resale of the Common Stock issuable pursuant to the Subscription Agreement and the Warrants.
  On January 23, 2024, Onconetix issued a non-convertible
  debenture (the "Debenture") to the Investor in the principal sum of $5.0 million, the payment of which shall offset the Purchase
  Price for the Units pursuant to the Subscription Agreement.
  8
  The Debenture has an interest rate of 4.0% per annum, and the
  principal and accrued interest are repayable in full upon the earlier of (i) the closing under the Subscription Agreement and (ii) June
  30, 2024. Additionally, the $5.0 million subscription amount under the Subscription Agreement shall be increased by the amount of interest
  payable under the Debenture.
  ENTADFI
  On April 19, 2023, the Company entered into
  the Veru APA. Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets
  related to Veru's ENTADFI business and assumed certain liabilities of Veru. The Transaction closed on April 19, 2023.
  The Company purchased substantially all of Veru's
  assets, rights and property related to ENTADFI for a total possible consideration of $100.0 million (as described below). The acquisition
  of ENTADFI capitalizes on the demonstrable success of the FDA-approved drug ENTADFI for treating benign prostatic hyperplasia and
  counteracting negative sexual side effects seen in men on alternative BPH therapies.
  Pursuant to the terms of the Veru APA, the Company
  agreed to provide Veru with initial consideration totaling $20.0 million, consisting of (i) $6.0 million paid upon the closing of the
  Transaction, (ii) an additional $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) an
  additional $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April 19,
  2024 and September 30, 2024. On September 29, 2023, the Company entered into an amendment (the "Amendment") of the Veru APA.
  Pursuant to the Amendment, the $4.0 million note payable originally due on September 30, 2023, was deemed paid and fully satisfied upon
  (1) the payment to Veru of $1 million in immediately available funds on September 29, 2023, and (2) the issuance to Veru by October 3,
  2023 of 3,000 shares of Series A Preferred Stock of the Company.
  The terms of the Series A Preferred Stock are
  set forth in the Certificate of Designations, which was filed with the State of Delaware on September 29, 2023. Pursuant to the Certificate
  of Designations, each share of Series A Preferred Stock will convert one year from the date of issuance of the Series A Preferred Stock
  into that number of shares of the Company's common stock determined by dividing the Stated Value (as defined in the Certificate
  of Designations) of $1,000 per share by the Conversion Price (as defined in the Certificate of Designations) of $0.5254 per share, subject
  to adjustment as provided in the Certificate of Designations, subject to certain shareholder approval limitations. The Series A Preferred
  Stock is entitled to share ratably in any dividends paid on the Company's common stock (on an as-if-converted-to-common-stock basis),
  has no voting rights except as to certain significant matters specified in the Certificate of Designations, and has a liquidation preference
  equal to the Stated Value of $1,000 per share plus any accrued but unpaid dividends thereon. The Series A Preferred Stock is redeemable
  in whole or in part at the Company's option at any time. The Certificate of Designations authorized the issuance of up to 10,000
  shares of Series A Preferred Stock.
  The Series A Preferred Stock issued to Seller
  is initially convertible, in the aggregate, into approximately 5,709,935 shares of the Company's common stock, subject to adjustment
  and certain shareholder approval limitations specified in the Certificate of Designations. Pursuant to the Amendment, the Company agreed
  to use commercially reasonable efforts to obtain such shareholder approval by December 31, 2023. The Company also agreed to include the
  shares of common stock issuable upon conversion of the Series A Preferred Stock in the next resale registration statement filed with the
  SEC.
  Additionally, the terms of the Veru APA require
  the Company to pay Veru up to an additional $80.0 million based on the Company's net sales from the ENTADFI business after
  closing. The Milestone Payments are payable as follows: (i) $10.0 million is payable if the Company's annual net sales from
  the ENTADFI business equal or exceed $100.0 million, (ii) $20.0 million is payable if the Company's annual net sales from
  the ENTADFI business equal or exceed $200.0 million, and (3) $50.0 million is payable if annual net sales from the ENTADFI business
  equal or exceed $500.0 million. No more than one Milestone Payment shall be made for the achievement of each net sales milestone. There
  can be no assurance that the net sales milestones for payment of any of the Milestone Payments will be reached.
  Furthermore, in connection with the Transaction,
  the Company assumed royalty and milestone obligations under an asset purchase agreement for tadalafil-finasteride combination entered
  into by Veru and Camargo Pharmaceutical Services, LLC on December 11, 2017. The Camargo Obligations assumed by the Company include a 6%
  royalty on all sales of tadalafil-finasteride and sales milestone payments of up to $22.5 million as follows: (i) $5.0 million is
  payable upon the first time the Company achieves net sales from ENTADFI of $100.0 million during a calendar year, (ii) $7.5 million
  is payable upon the first time the Company achieves net sales from ENTADFI of $200.0 million during a calendar year, and (3) $10.0 million
  is payable upon the first time the Company achieves net sales from ENTADFI of $300.0 million during a calendar year.
  9
  WraSer
  On June 13, 2023 (the "Execution Date"),
  the Company entered into an asset purchase agreement with WraSer, LLC, a Mississippi limited liability company, Xspire Pharma,
  LLC, a Mississippi limited liability company (collectively, the "Seller"), and Legacy-Xspire Holdings, LLC, a
  Delaware limited liability company and the parent company of the Seller ("Parent") (the "WraSer APA"). Pursuant
  to, and subject to the terms and conditions of, the WraSer APA, on the Closing Date (as defined below) the Company will purchase six FDA-approved
  pharmaceutical assets across several indications, including cardiology, otic infections, and pain management (the "WraSer Assets").
  Under the terms of the WraSer APA, the Company
  will purchase the WraSer Assets for (i) $3.5 million in cash at signing of the WraSer APA (the "Signing Cash"); (ii) $4.5
  million in cash on the later of (x) 90 days after the signing of the WraSer APA or (y) the date that all closing conditions under the
  WraSer APA are met or otherwise waived (the "Closing Date"); (iii) 1.0 million shares of the Company's common stock
  (the "Closing Shares") issuable on the Closing Date, and (iv) $500,000 in cash one year from the Closing Date. The closing
  of the transaction is subject to certain customary closing conditions and the delivery to the Company of financial statements of Seller
  and Parent for the fiscal years ended December 31, 2022 and 2021 audited by a qualified auditor reasonably acceptable to the Company.
  Within 90 days of the Closing Date, the Company
  will use its best efforts to file with the SEC, (at its sole cost and expense,) a registration statement to register on Form S-3 registering
  under the Securities Act of 1933, as amended (the "Securities Act"), the resale of the Closing Shares and will use its best
  efforts to have the registration statement declared effective as soon as practicable after filing.
  In conjunction with the WraSer APA, the Company and the Seller entered
  into a Management Services Agreement (the "MSA") on the Execution Date. Pursuant to the terms of the MSA, the Company was
  to act as the manager of the Seller's business during the period between the Execution Date and Closing Date. During this period,
  the Company was to make advances to WraSer, if needed to sustain operations. The Company's involvement as manager of the Seller's
  business ended when WraSer filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court (see below). If, on the
  Closing Date, the Seller's cash balance is in excess of the target amount specified in the MSA of $1.1 million (the "Cash
  Target"), the Company was to apply that excess to the $4.5 million cash payment due upon closing. Conversely, if there is a shortfall,
  the Company would have been required to remit the difference to the Seller over time. Specifically, as the Company collected accounts
  receivable generated after the Closing Date, the Company would have been required to remit 50% of the collections to the Seller until
  the shortfall is paid in full. The MSA terminates on the Closing Date.
  The WraSer APA can be terminated prior to closing
  as follows (i) upon agreement with all parties; (ii) upon breach of contract of either party, uncured within 20 days of notice. If the
  WraSer APA is terminated upon agreement with all parties or upon uncured breach of contract by the Seller, the initial $3.5 million payment
  is retained by the Sellers. If it is determined that there is an uncured breach of contract by the Seller, and the WraSer APA is terminated,
  the Company will have an unsecured claim against WraSer for the $3.5 million payment made by the Company upon execution of the WraSer
  APA. The closing of the Transaction is subject to various closing conditions, including submission of the FDA transfer documentation to
  transfer ownership of the acquired product regulatory approvals to the Company.
  On September 26, 2023, WraSer and its affiliates
  filed for relief under chapter 11 of the U.S. Bankruptcy Code in the Bankruptcy Court.
  10
  On October 4, 2023, the parties agreed to amend
  the WraSer APA. Shortly after its bankruptcy filing, WraSer filed a motion seeking approval of the WraSer APA as amended. The amendment,
  among other things, eliminates the $500,000 post-closing payment due June 13, 2024 and staggers the $4.5 million cash payment that the
  Company would otherwise have to pay at closing to: (i) $2.2 million to be paid at closing, (ii) $2.3 million, to be paid in monthly installments
  of $150,000 commencing January 2024 (the "Post-Closing Payment") and (iii) 789 shares of Series A Preferred Stock to be paid
  at closing. The amendment also reduced the number of products we were acquiring by excluding pain medications and including only (i) Ciprofloxacin
  0.3% and Fluocinolone 0.025% Otic Solution, under the trademark OTOVEL and its Authorized Generic Version approved under US FDA NDA No.
  208251, (ii) Ciprofloxacin 0.2% Otic solution, under the trademark CETRAXAL, and (iii) Vorapaxar Sulfate tablets under the trademark Zontivity
  approved under US FDA NDA N204886.
  In October 2023, we were alerted by WraSer that
  its sole manufacturer for the active pharmaceutical ingredient ("API") for Zontivity, the key driver for the WraSer acquisition,
  would no longer manufacture the API for Zontivity. We believed that this development constituted a Material Adverse Effect under the APA
  enabling us to terminate the APA and MSA. On October 20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy
  Court to exercise our termination rights under the WraSer APA, as amended. On December 18, 2023, the Bankruptcy Court entered an Agreed
  Order lifting the automatic stay to enable us to exercise our rights to terminate the APA and the MSA without prejudice to the parties'
  respective rights, remedies, claims and defenses they had against one another under the APA and MSA. On December 21, 2023, we filed a
  Notice with the Bankruptcy Court terminating the APA and MSA. WraSer has advised us that it does not believe that a Material Adverse Event
  occurred. Due to the WraSer bankruptcy filing and our status as an unsecured creditor of WraSer, it is also unlikely that we will recover
  the $3.5 million Signing Cash or any costs and resources in connection with services provided by the Company under the WraSer MSA.
  Agreement with Cardinal Health
  On September 21, 2023,
  the Company entered into an Exclusive Distribution Agreement (the "Exclusive Distribution Agreement"), effective as of
  September 20, 2023 (the "Effective Date"), with Cardinal Health 105, LLC ("Cardinal Health"). Pursuant to,
  and subject to the terms and conditions of, the Exclusive Distribution Agreement, the Company engaged Cardinal Health as its
  exclusive third-party logistics distribution agent for sales of all of the Company's commercial assets. The term of the
  Distribution Agreement is three years from the Effective Date and automatically renews for additional terms of one year each unless
  terminated pursuant to the terms of the Exclusive Distribution Agreement. Under the terms of the Exclusive Distribution Agreement,
  the Company must pay to Cardinal Health a one-time start-up fee of $15,500, and upon launch of ENTADFI, a monthly account management
  fee of $7,000, and other fees for various services, including post-launch program implementation, information systems, warehouse
  operations, and financial services.
  Corporate Name Change and Amendment to Bylaws
  On December 15, 2023, the Company filed an amendment
  to its A&R COI with the Secretary of State of Delaware to change its corporate name from "Blue Water Biotech, Inc." to
  "Onconetix, Inc."
  In connection with the name change, the Company
  also amended the Company's bylaws to reflect the new corporate name.
  On May 31, 2023, the Board amended the Company's
  bylaws to reduce the quorum requirement at meetings of the Company's stockholders from a majority of the voting power of the outstanding
  shares of stock of the Company entitled to vote, to one-third of the voting power of the outstanding shares of stock of the Company entitled
  to vote, effective immediately. No other changes were made to the bylaws.
  Warrant Inducement
  On July 31, 2023, the Company entered into the
  Inducement Letter with the Holder of the Existing PIOs. Pursuant to the Inducement Letter, the Holder agreed to exercise for cash its
  Existing PIOs to purchase an aggregate of 2,486,214 shares of the Company's common stock, at a reduced exercise price of $1.09 per
  share, in exchange for the Company's agreement to issue Inducement PIOs to purchase up to 4,972,428 shares of the Company's
  common stock. The Inducement PIOs have substantially the same terms as the Existing PIOs. On August 2, 2023, the Company consummated the
  Warrant Inducement. The Company received aggregate net proceeds of approximately $2.3 million from the Warrant Inducement, after deducting
  placement agent fees and other offering expenses payable by the Company.
  11
  The Company engaged Wainwright to act as its placement
  agent in connection with the Warrant Inducement and paid Wainwright a cash fee equal to 7.5% of the gross proceeds received from the exercise
  of the Existing PIOs as well as a management fee equal to 1.0% of the gross proceeds from the exercise of the Existing PIOs. The Company
  also agreed to reimburse Wainwright for its expenses in connection with the exercise of the Existing PIOs and the issuance of the Inducement
  PIOs, up to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses and agreed to pay Wainwright for non-accountable
  expenses in the amount of $35,000. In addition, the exercise for cash of the Existing PIOs triggered the issuance to Wainwright or its
  designees, warrants to purchase 149,173 shares of common stock, which were issuable in accordance with the terms of Contingent Warrants
  issuable to Wainwright in connection with the August 2022 Private Placement Transaction, and have the same terms as the Inducement PIOs,
  except for an exercise price equal to $1.3625 per share. The Company also agreed to issue warrants to Wainwright upon any exercise for
  cash of the Inducement PIOs, that number of shares of common stock equal to 6.0% of the aggregate number of such shares of common stock
  underlying the Inducement PIOs that have been exercised, also with an exercise price of $1.3625. The maximum number of warrants issuable
  under this provision is 298,346.
  Nasdaq Compliance
  On September 18, 2023, we received notice from
  Nasdaq staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were
  not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth
  in Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule"). We have 180 days from September 18, 2023, or through March 16, 2024,
  to regain compliance with the Bid Price Rule.
  On August 22, 2023, we received a notice from
  Nasdaq that we were not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to timely file all required
  periodic financial reports with the SEC, given our failure to timely file our quarterly report on Form 10-Q for the quarter ended
  June 30, 2023. On October 20, 2023, we filed our Form 10-Q for the period ended June 30, 2023, and on November 1, 2023, we announced that
  we had regained compliance with Nasdaq Listing Rule 5250(c)(1).
  12
  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.onconetix.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:
  22,324,576 shares of our Common Stock are outstanding as of January 25, 2024.
  Common Stock Offered:
  Up to 885,796 shares of Common Stock for sale by the Selling Stockholders (which include our employees, consultants, executive officers and directors) for their own account pursuant to the 2022 Plan.
  Selling Stockholders:
  The Selling Stockholders are set forth in the section entitled "Selling Stockholders" of this reoffer prospectus on page 40. 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(i).
  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:
  ONCO
  13
  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 operations;
  ●
  the success, cost and timing of our future clinical
      trials;
  ●
  our ability to obtain and maintain the necessary regulatory approvals
      to market and commercialize our products and future product candidates;
  ●
  the potential that results of pre-clinical and clinical trials indicate 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;
  14
  ●
  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;
  ●
  our reliance on third parties, including manufacturers and logistics companies;
  ●
  the success of competing therapies and products that are or become available;
  ●
  our ability to commercialize ENTADFI and Proclarix and integrate the assets and commercial operations acquired;
  ●
  our ability to successfully compete against current and future competitors;
  ●
  our ability to expand our organization to accommodate 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 products and 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.
  15
  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.
  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.
  16
  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.
  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
  .
  17
  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.
  18
  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.
  19
  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;
  20
  ●
  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.
  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.
  21
  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.
  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.
  22
  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.
  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.
  23
  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.
  Healthcare Reform
  Coverage and Reimbursement
  The future commercial success
  of our products  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.
  24
  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.
  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, and we expect such challenges and amendments to continue.
  Since January 2017, Former 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.
  25
  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.
  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. 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. In August
  2022, Congress passed the Inflation Reduction Act of 2022, which included a provision allowing Medicare to negotiate drug prices directly
  with pharmaceutical manufacturers. This provision may impact pricing strategies and determinations in the future. 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.
  26
  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.
  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.
  27
  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.
  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.
  28
  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.
  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.
  29
  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).
  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,
  30
  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.
  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.
  31
  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.
  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.
  Employees
  As of January 25, 2024, we
  had 5 full-time and 11 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 currently lease an office
  located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.
  Additionally, Proteomedix leases
  office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expires on June 30, 2025, subject to renewal for
  successive two-year terms.
  Legal Proceedings
  From time to time we may be
  involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any
  material legal proceedings.
  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.onconetix.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.
  32
  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.
  There is substantial doubt about our ability
  to continue as a "going concern."
  The Company has incurred substantial operating
  losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2023,
  the Company had cash of approximately $7.7 million, a working capital deficit of approximately $8.1 million and an accumulated
  deficit of approximately $34.4 million.
  The Company will require significant additional capital to fund its
  continuing operations, satisfy existing and future obligations and liabilities, and otherwise support the Company's working capital
  needs and business activities, including making the remaining payments to Veru, the commercialization of ENTADFI and Proclarix, and the
  development and commercialization of its current product candidates and future product candidates. In addition, if Stockholder Approval
  is not obtained by January 1, 2025, the Company may be obligated to cash settle the Series B Convertible Preferred Stock. Management's
  plans include generating product revenue from sales of ENTADFI, which is subject to further successful commercialization activities, and
  Proclarix, which may still be subject to further successful commercialization activities within certain jurisdictions. Certain of the
  commercialization activities are outside of the Company's control, including but not limited to, securing contracts with wholesalers
  and third party payers, securing contracts with third-party logistics providers, obtaining required licensure in various jurisdictions,
  as well as attempting to secure additional required funding through equity or debt financings if available. However, there are currently
  no commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable
  terms, if at all. If the Company is unable to secure additional capital, it may be required to delay or curtail any future clinical trials,
  development and/or commercialization of products and product candidates, and it may take additional measures to reduce expenses in order
  to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These conditions raise substantial doubt about
  the Company's ability to continue as a going concern for a period of time within one year after the date of the issuance of the
  condensed financial statements incorporated by reference in this Registration Statement.
  We entered into an asset purchase agreement
  and management services agreement with WraSer, which have been terminated because we believe that a material adverse event has occurred
  with respect to the WraSer Assets. However, the termination is subject to WraSer's right to challenge the termination and assert
  claims against us
  On June 13, 2023, we entered into the WraSer APA
  and MSA with WraSer in connection with the purchase of the WraSer Assets. Under the WraSer APA, we paid $3.5 million in cash to WraSer
  at signing (the "Signing Cash").In October 2023, we were alerted by WraSer that its sole manufacturer for the active pharmaceutical
  ingredient ("API") for Zontivity, the key driver for the WraSer acquisition, would no longer manufacture the API for Zontivity.
  We believed that this development constituted a Material Adverse Effect under the APA enabling us to terminate the APA and MSA. On October
  20, 2023, we filed a motion for relief from the automatic stay in the Bankruptcy Court to exercise our termination rights under the WraSer
  APA, as amended. On December 18, 2023, the Bankruptcy Court entered an Agreed Order lifting the automatic stay to enable us to exercise
  our rights to terminate the APA and the MSA without prejudice to the parties' respective rights, remedies, claims and defenses they
  had against one another under the APA and MSA. On December 21, 2023, we filed a Notice with the Bankruptcy Court terminating the APA and
  MSA. WraSer has advised us that it does not believe that a Material Adverse Event occurred. Due to the WraSer bankruptcy filing and our
  status as an unsecured creditor of WraSer, it is also unlikely that we will recover the $3.5 million Signing Cash or any costs and resources
  in connection with services provided by the Company under the WraSer MSA.
  33
  Company shareholders may not realize a benefit
  from the ENTADFI or Proteomedix acquisitions commensurate with the ownership dilution they will experience in connection with the
  transactions.
  If the Company is unable to realize the full strategic
  and financial benefits currently anticipated from the recent ENTADFI and Proteomedix acquisitions, our shareholders may experience a dilution
  of their ownership interests our Company without receiving any commensurate benefit, or only receiving part of the commensurate benefit
  to the extent the Company is able to realize only part of the strategic and financial benefits currently anticipated from the transactions.
  The issuance or conversion of securities
  would result in significant dilution in the equity interest of existing shareholders and adversely affect the marketplace of the securities.
  The issuance or conversion of common shares or
  other securities convertible into common shares would result in significant dilution in the equity interest of existing shareholders and
  adversely affect the market price of the common shares. We have issued 3,000 shares of Series A Preferred Stock to Veru which are initially
  convertible one year from issuance, in the aggregate, into 5,709,935 shares of the Company's common stock, subject to adjustment
  and certain shareholder approval limitations specified in the Certificate of Designations. We have issued
  2,696,729
  shares of Series B Preferred Stock to former shareholders of Proteomedix which are initially convertible, in the aggregate, into
  269,672,900
  shares of the Company's common stock, subject to adjustment and certain
  shareholder approval limitations specified in the Certificate of Designations.
  We may have violated Section 13(k) of the
  Exchange Act (implementing Section 402 of the Sarbanes-Oxley Act of 2002) and may be subject to sanctions as a result.
  Section 13(k) of the Exchange Act provides that
  it is unlawful for a company that has a class of securities registered under Section 12 of the Exchange Act to, directly or indirectly,
  including through any subsidiary, extend or maintain credit in the form of a personal loan to or for any of its directors or executive
  officers. In the fiscal year ended December 31, 2022 and the nine months ended September 30, 2023, we paid certain expenses of our former
  Chief Executive Officer and Chairman of the Board, which may be deemed to be personal loans made by us to our former Chief Executive Officer
  and Chairman of the Board that are not permissible under Section 13(k) of the Exchange Act. Issuers that are found to have violated Section
  13(k) of the Exchange Act may be subject to civil sanctions, including injunctive remedies and monetary penalties, as well as criminal
  sanctions. The imposition of any of such sanctions on us could have a material adverse effect on our business, financial position, results
  of operations or cash flows.
  Misconduct and errors by our current and
  former employees and our third-party service providers could cause a material adverse effect on our business and reputation.
  Our employees and third-party service providers
  are integral to our business operations, including confidential information. If any such information were leaked to unintended recipients
  due to human error, theft, malicious sabotage or fraudulent manipulation, we may be subject to liability for loss of such information.
  Further, if any of our employees or third-party service providers absconded with our proprietary data or know-how in order to compete
  with us, our competitive position may be materially and adversely affected.
  Any improper conduct or use of funds by any
  of our employees or third-party service providers in contravention of our protocols and policies may lead to regulatory and disciplinary
  proceedings involving us. We may be perceived to have facilitated or participated in such conduct and we could be subject to liability,
  damages, penalties and reputational damage. It is impossible to completely identify and eradicate all risks of misconduct or human errors,
  and our precautionary measures may not be able to effectively detect and prevent such risks from happening.
  Occurrence of any of the above risks could result
  in a material adverse effect on our business and results of operations, as we are exposed to potential liability to borrowers and investors,
  reputational damage, regulatory intervention, financial harm. Our ability to attract new and retain existing borrowers and investors and
  operate as an ongoing concern may be impaired.
  34
  We may consider strategic alternatives in
  order to maximize stockholder value, including financing, 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 not be successful.
  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 business activities because they may be
  deemed to be at too early of a stage of development for collaborative effort. Any delays in entering into new strategic partnership agreements
  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.
  As a result of our failure to timely file
  our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, we are currently ineligible to file new short form registration
  statements on Form S-3, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all.
  Form S-3 permits eligible issuers to conduct registered
  offerings using a short form registration statement that allows the issuer to incorporate by reference its past and future filings and
  reports made under the Securities Exchange Act of 1934, as amended, or the Exchange Act. In addition, Form S-3 enables eligible
  issuers to conduct primary offerings "off the shelf" under Rule 415 of the Securities Act of 1933, as amended, or the Securities
  Act. The shelf registration process, combined with the ability to forward incorporate information, allows issuers to avoid delays and
  interruptions in the offering process and to access the capital markets in a more expeditious and efficient manner than raising capital
  in a standard registered offering pursuant to a Registration Statement on Form S-1.
  As a result of our failure to timely file our
  Quarterly Report on Form 10-Q for quarter ended June 30, 2023, we are currently ineligible to file new short form registration
  statements on Form S-3 and we will be unable to conduct "off the shelf" offerings under Rule 415 of the Securities
  Act using our currently effective Registration Statement on Form S-3 (File No. 333-270383) after we file our annual report for the
  fiscal year ending December 31, 2023. As a result, we may be unable to conduct an "at the market" offering pursuant to our
  At The Market Offering Agreement with H.C. Wainwright & Co., LLC after such date. In addition, if we seek to access the capital markets
  through a registered offering during the period of time that we are unable to use Form S-3, we may be required to publicly disclose the
  proposed offering and the material terms thereof before the offering commences, we may experience delays in the offering process due to
  SEC review of a Form S-1 registration statement and we may incur increased offering and transaction costs and other considerations. Disclosing
  a public offering prior to the formal commencement of an offering may result in downward pressure on our stock price. In addition, our
  inability to conduct an offering "off the shelf" may require us to offer terms that may not be advantageous (or may be less
  advantageous) to us or may generally reduce our ability to raise capital in a registered offering. If we are unable to raise capital through
  a registered offering, we would be required to conduct our financing transactions on a private placement basis, which may be subject to
  pricing, size and other limitations imposed under Nasdaq rules.
  35
  If we fail to maintain proper and effective
  internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. 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.
  We are subject to the reporting requirements of
  the Exchange Act, the Sarbanes-Oxley Act and Nasdaq rules and regulations. The Sarbanes-Oxley Act requires, among other things, that we
  maintain effective disclosure controls and procedures and internal control over financial reporting. Effective internal control over financial
  reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is
  designed to prevent fraud. We must perform system and process evaluation and testing of our internal controls over financial reporting
  to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual Report on Form
  10-K for each year, as required by Section 404 of the Sarbanes-Oxley Act ("Section 404"). This requires significant management
  efforts and requires us to incur substantial professional fees and internal costs to expand our accounting and finance functions. Any
  failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to
  meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404, or any
  subsequent testing by our independent registered public accounting firm, as and when required, may reveal deficiencies in our internal
  controls over financial reporting that are deemed to be significant deficiencies or material weaknesses or that may require prospective
  or retroactive changes to our financial statements, or may identify other areas for further attention or improvement. Furthermore, we
  cannot be certain that our efforts will be sufficient to remediate or prevent future material weaknesses or significant deficiencies from
  occurring.
  We do not yet have effective disclosure controls
  and procedures, or internal controls over all aspects of our financial reporting. Specifically, we have identified the following control
  deficiencies which we believe are material weaknesses.
  ●
  We did not maintain an effective
  control environment as there was an inadequate segregation of duties with respect to certain cash disbursements. The processing and the
  approval for payment of credit card transactions and certain bank wires were being handled by the former CEO and an accounting employee,
  and the accounting employee was responsible for the reconciliation of credit card statements and bank statements. This allowed these
  individuals to submit unauthorized payments to unauthorized third parties.
  ●
  We did not have an effective
  risk assessment process over the identification of fraud risks surrounding the authorization, identification, approval and reporting
  of personal expenses charged to the Company's corporate credit cards.
  ●
  We did not design and maintain effective monitoring of compliance
  with established accounting policies and procedures.
  ●
  Our controls over the approval
  and reporting of expenses paid with the Company's credit cards and certain bank wires were not designed and maintained to achieve
  the Company's objectives.
  ●
  We failed to employ a
  sufficient number of staff to maintain optimal segregation of duties, maintain adequate internal controls surrounding information technology
  procedures, such as a lack of a written information security policy, maintain adequate controls over the approval and posting of journal
  entries, 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.
  ●
  We do not yet have adequate
  internal controls in place for the timely identification, approval or reporting of related party transactions.
  We cannot provide assurances that these weaknesses
  will be effectively remediated or that additional material weaknesses will not occur in the future.
  As a result of the material weaknesses in our
  internal controls over financial reporting described above, and other matters raised or that may in the future be raised by the SEC, we
  may face for the prospect of litigation or other disputes which may include, among others, claims invoking the federal and state securities
  laws, contractual claims or other claims arising from the material weaknesses in our internal control over financial reporting and the
  preparation of our financial statements, any of which claims could result in adverse effects to our business. As of the date hereof, we
  have no knowledge of any such litigation or dispute.
  36
  We expect to rely on third party manufacturers
  for ENTADFI and Proclarix.
  For the foreseeable future, we expect to and do
  rely on third-party manufacturers and other third parties to produce, package and store sufficient quantities of ENTADFI and Proclarix
  to meet demand. ENTADFI and Proclarix is complicated and expensive to manufacture. If our third-party manufacturers fail to deliver ENTADFI
  or Proclarix for commercial sale on a timely basis, with sufficient quality, and at commercially reasonable prices, we may be required
  to delay or suspend commercial sales and/or production of ENTADFI and Proclarix. While we may be able to identify replacement third-party
  manufacturers or develop our own manufacturing capabilities for ENTADFI and Proclarix, this process would likely cause a delay in the
  availability of ENTADFI and/or Proclarix and an increase in costs. In addition, third-party manufacturers may have a limited number of
  facilities in which ENTADFI and Proclarix can be produced, and any interruption of the operation of those facilities due to events such
  as equipment malfunction or failure or damage to the facility by natural disasters could result in the cancellation of shipments, loss
  of product in the manufacturing process or a shortfall in ENTADFI and Proclarix.
  In addition, regulatory requirements could pose
  barriers to the manufacture of ENTADFI and Proclarix. Third-party manufacturers are required to comply with the FDA's cGMPs. As
  a result, the facilities used by any manufacturers of ENTADFI Proclarix, must maintain a compliance status acceptable to the FDA. Holders
  of NDAs, or other forms of FDA approvals or clearances, or those distributing a regulated product under their own name, are responsible
  for manufacturing even though that manufacturing is conducted by a third-party contract manufacturing organization ("CMO").
  Our third-party manufacturers will be required to produce ENTADFI and Proclarix under FDA cGMPs in order to meet acceptable standards.
  Our third-party manufacturers may not perform their obligations under their agreements with us or may discontinue their business before
  the time required by us to commercialize our drug candidates. In addition, our manufacturers will be subject to ongoing periodic unannounced
  inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. Failure
  by any of our manufacturers to comply with applicable cGMPs could result in sanctions being imposed on us, including fines, injunctions,
  civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply, recalls, withdrawals,
  issuance of safety alerts and criminal prosecutions, any of which could have a material adverse effect on our business, financial condition,
  results of operations and prospects. Finally, we also could experience manufacturing delays if our CMOs give greater priority to the supply
  of other products over ENTADFI or Proclarix or otherwise do not satisfactorily perform according to the terms of their agreements with
  us.
  If any supplier for ENTADFI or Proclarix experiences
  any significant difficulties in its manufacturing processes, does not comply with the terms of the agreement between us or does not devote
  sufficient time, energy and care to providing our manufacturing needs, we could experience significant interruptions in the supply of
  ENTADFI and/or Proclarix, which could impair our ability to supply ENTADFI and/or Proclarix at the levels required for commercialization
  and prevent or delay its successful development and commercialization.
  Disruptions to or significantly increased
  costs associated with transportation and other distribution channels for ENTADFI and/or Proclarix may adversely affect our margins and
  profitability.
  We expect to rely on the uninterrupted and efficient
  operation of third-party logistics companies to transport and deliver ENTADFI and Proclarix. These third-party logistics companies may
  experience disruptions to the transportation channels used to distribute our products, including disruptions caused by the COVID-19 pandemic,
  increased airport and shipping port congestion, a lack of transportation capacity, increased fuel expenses, and a shortage of manpower
  or capital or due to other business interruptions. Disruptions to the transportation channels experienced by our third-party logistics
  companies may result in increased costs, including the additional use of airfreight to meet demand. Disruptions to this business model
  or our relationship with the third party if, for example, performance fails to meet our expectations, could harm our business.
  We may fail or elect not to commercialize
  our products.
  We may not successfully commercialize our products.
  We or our collaboration partners in any potential commercial marketing efforts of our products may not be successful in achieving widespread
  patient or physician awareness or acceptance of this product. Also, we may be subject to pricing pressures from competitive products or
  from governmental or commercial payors or regulatory bodies that could make it difficult or impossible for us to commercialize our products.
  Any failure to commercialize our products could have a material adverse effect on our future revenue and our business.
  If we fail to commercialize our products, our
  business, financial condition, results of operations and prospects may be materially adversely affected and our reputation in the industry
  and in the investment community would likely be damaged.
  37
  We may not be able to gain and retain market
  acceptance for our products.
  Physicians may not prescribe our products, which
  would prevent our products from generating revenue. Market acceptance of our products by physicians, patients and payors, will depend
  on a number of factors, many of which are beyond our control, including the following:
  ●
  the clinical indications for
  which our products are approved, if at all;
  ●
  acceptance by physicians and
  payors of our products as safe and effective treatment or test;
  ●
  the cost in relation to alternative
  treatments or tests;
  ●
  the relative convenience and
  ease of administration of our products for the conditions for which they are intended;
  ●
  the availability and efficacy
  of competitive drugs or tests;
  ●
  the effectiveness of our sales
  and marketing efforts;
  ●
  the extent to which our products
  are approved for inclusion on formularies of hospitals and managed care organizations;
  ●
  the availability of coverage
  and adequate reimbursement by third parties, such as insurance companies and other health care payors, or by government health care programs,
  including Medicare and Medicaid;
  ●
  limitations or warnings contained
  in a product's FDA or other applicable regulatory agency's approved labeling; and
  ●
  prevalence and severity of
  adverse side effects.
  Even if the medical community accepts that our
  products are safe and efficacious for its approved indications, physicians may not immediately be receptive to the use or may be slow
  to adopt such products as an accepted treatment or test for the conditions for which it is intended. Without head-to-head comparative
  data, we will also not be able to promote our products as being superior to competing products. If our products do not achieve an adequate
  level of acceptance by physicians and payors, we may not generate sufficient or any revenue from this product. In addition, our efforts
  to educate the medical community and third-party payors on the benefits of our product may require significant resources and may never
  be successful.
  In addition, 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;
  ●
  Unforeseen complications arise
  with respect to use of our products or
  ●
  sufficient third-party insurance
  coverage or reimbursement does not remain available.
  38
  ENTADFI is subject to competition from other
  BPH drugs and larger, well-established companies with substantially greater resources than us.
  We are engaged in the marketing of a product in
  industries, including the pharmaceutical industry, that are highly competitive. The pharmaceutical industry is also characterized by extensive
  research and rapid technological progress. Potential competitors with respect to ENTADFI in North America, Europe and elsewhere include
  major pharmaceutical companies, specialty pharmaceutical companies and biotechnology firms, universities and other research institutions
  and government agencies. Many of our competitors have substantially greater research and development and regulatory capabilities and experience,
  and substantially greater management, manufacturing, distribution, marketing and financial resources, than we have. We may be unable to
  compete successfully against current and future competitors, and competitive pressures could have a negative effect on our net revenues
  and profit margins.
  Other parties have developed and marketed drugs
  for BPH that have been accepted by the physician, patient and payor communities. Many of these other products have also reached the point
  where they are now generic drugs, which means that they are sold at a very low price, a price which ENTADFI may not be able to meet which
  could limit the reach of ENTADFI into the physician, patient and payor communities, including government payors.
  We may not be able to successfully implement
  our strategy to grow sales of ENTADFI and Proclarix in the U.S. market or, if authorized, in any foreign market.
  We may not be able to expand sales of ENTADFI
  or Proclarix through partnering with telemedicine or other partners or with commercial diagnostic providers or through our own commercialization
  efforts. We may not be able to command a price with private and government payors for ENTADFI or Proclarix that would justify our devotion
  of significant resources to attempting to grow sales of ENTADFI or Proclarix. We may not be able to compete efficiently or effectively
  in a mature BPH market which is heavily generic. Failure to grow sales of ENTADFI or Proclarix would have a negative effect on our revenue
  and future plans.
  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.
  On September 18, 2023, we received notice from
  Nasdaq staff indicating that, based upon the closing bid price of the Common Stock for the prior 30 consecutive business days, we were
  not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth
  in Nasdaq Listing Rule 5550(a)(2). We have 180 days from September 18, 2023, or through March 16, 2024, to regain compliance with the
  Bid Price Rule.
  If Nasdaq delists our common stock from trading
  on its exchange for failure to meet the Bid Price Rule or any other 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;
  ●
  a limited amount of analyst
  coverage; and
  ●
  a decreased ability to issue
  additional securities or obtain additional financing in the future.
  39
  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
  Number of
  Shares
  Offered for Resale
  Shares Beneficially Owned
  After Resale
  Number(2)
  Percent(3)
  Number
  Percent(3)
  Erin Henderson
  Former Chief Business Officer
  342,682
  (4)
  1.5
  %
  317,930
  24,752
  *
  James Sapirstein
  Director
  56,935
  (5)
  *
  56,935
  —
  —
  Simon Tarsh
  Director
  10,433
  (6)
  *
  10,433
  —
  —
  Timothy Ramdeen
  Director
  8,746
  (7)
  *
  8,746
  —
  —
  Brian Price
  Consultant
  32,552
  (8)
  *
  32,552
  —
  —
  Sunetra Gupta
  Advisory Board Member
  459,200
  (9)
  2.1
  %
  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.
  (3)
  Percentage is computed with reference to 22,324,576 shares of our Common Stock outstanding as of January
  30, 2024. In addition, we deemed outstanding shares of Common Stock subject to options or warrants held by each person for purposes of
  computing the percentage of ownership for such person. However, we did not deem such shares outstanding for the purpose of computing the
  percentage ownership of any other person.
  (4)
  Includes 24,752 shares of Common Stock, 150,000 restricted shares of Common Stock, and 167,930 shares
  of Common Stock underlying options.
  (5)
  Includes 6,360 restricted shares of Common Stock and 50,575 shares of Common Stock underlying options.
  (6)
  Includes 6,360 restricted shares of Common Stock and 4,073 shares of Common Stock underlying options.
  (7)
  Includes 6,360 restricted shares of Common Stock and 2,386 shares of Common Stock underlying options.
  (8)
  Includes 32,552 shares of Common Stock underlying options.
  (9)
  Includes 459,200 shares of Common Stock underlying options.
  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.
  40
  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.
  41
  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.
  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.
  42
  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.
  43
  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.
  ONCONETIX, INC.
  885,796 Shares of
  Common Stock
  PROSPECTUS
  February 1, 2024
  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,
      2022 as filed with the SEC on March 9, 2023;
  (ii)
  our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
      as filed with the SEC on
  May 12, 2023
  ; the quarter ended June 30, 2023 as filed with the SEC on
  October 20, 2023
  ; and the quarter
      ended September 30, 2023 as filed with the SEC on
  November 17, 2023
  ;
  (iii)
  our Current Reports on Form 8-K dated
  March 29, 2023
  ,
  April 20, 2023
  ,
  April 24, 2023
  ,
  June 6, 2023
  ,
  June 14, 2023
  ,
  July 6, 2023
  ,
  July 11, 2023
  ,
  July 25, 2023
  ,
  July 25, 2023
  ,
  July 31, 2023
  ,
  August 1, 2023
  ,
  August 3, 2023
  ,
  August 10, 2023
  ,
  August 22, 2023
  ,
  August 28, 2023
  ,
  September 8, 2023
  ,
  September 22, 2023
  ,
  October 3, 2023
  ,
  October 10, 2023
  ,
  December 18, 2023
  ,
  December 27, 2023
  ,
  December 28, 2023
  ,
  January 12, 2024
  ,
  January 19, 2024
  and
  January 29, 2024
  .
  (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 Bruce Harmon, c/o Onconetix, 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.onconetix.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.
  II-
  1
  Item 5. Interests of Named Experts and Counsel
  Not applicable.
  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.
  II-
  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 herewith)
  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.
  II-
  3
  (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(c), 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.
  (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.
  II-
  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 February 1, 2024.
  ONCONETIX, INC.
  By:
  /s/ Dr. Ralph Schiess
  Dr. Ralph Schiess
  Interim Chief Executive Officer
  POWER OF ATTORNEY
  KNOW ALL MEN BY THESE PRESENTS
  ,
  that we, the undersigned officers and directors of Onconetix, Inc., a Delaware corporation, do hereby constitute and appoint Dr. Ralph
  Schiess 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/ Dr. Ralph Schiess
  Interim Chief Executive Officer
  February 1, 2024
  Dr. Ralph Schiess
  (Principal Executive Officer)
  /s/ Bruce Harmon
  Chief Financial Officer
  February 1, 2024
  Bruce Harmon
  (Principal Financial Officer)
  /s/ James Sapirstein
  Non-Executive Chairman of the Board
  February 1, 2024
  James Sapirstein
  /s/ Timothy Ramdeen
  Director
  February 1, 2024
  Timothy Ramdeen
  /s/ Simon Tarsh
  Director
  February 1, 2024
  Simon Tarsh
  II-5