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  <P STYLE="margin-top: 0pt; text-align: center; margin-bottom: 0pt; padding: 0pt">As filed with the Securities and Exchange
  Commission on October 2, 2015&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: right">Registration No. 333-______</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"></P>
  
  <!-- Field: Rule-Page --><DIV ALIGN="LEFT" STYLE="margin-top: 0; margin-bottom: 0"><DIV STYLE="font-size: 1pt; border-top: Black 2pt solid; border-bottom: Black 1pt solid; width: 100%">&nbsp;</DIV></DIV><!-- Field: /Rule-Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNITED STATES</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>WASHINGTON, DC 20549</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>FORM S-8</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>REGISTRATION STATEMENT</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>UNDER</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>THE SECURITIES ACT OF 1933</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><FONT STYLE="font-size: 12pt"><B>RELMADA
  THERAPEUTICS, INC.</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Exact Name of Registrant as Specified in Its
  Charter)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><B>&nbsp;</B></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 49%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><B>Nevada</B></TD>
      <TD STYLE="width: 2%; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="width: 49%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><B>45-5401931</B></TD></TR>
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">(State&nbsp;or&nbsp;other&nbsp;Jurisdiction&nbsp;of</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">(I.R.S&nbsp;Employer</TD></TR>
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">Incorporation&nbsp;or&nbsp;Organization)</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">Identification&nbsp;Number)</TD></TR>
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><B>757 Third Avenue, Suite 2018,&nbsp;New York,&nbsp;New York</B></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><B>10017</B></TD></TR>
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">(Address&nbsp;of&nbsp;Principal&nbsp;Executive&nbsp;Offices)</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif">(Zip&nbsp;Code)</TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;<B>RELMADA THERAPEUTICS,
  INC.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>2014 STOCK OPTION AND EQUITY INCENTIVE STOCK
  PLAN, AS AMENDED</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center">(Full Title of the Plan)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Sergio Traversa</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Chief Executive Officer</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>757 Third Avenue, Suite 2018</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>New York, New York 10017</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Phone: (212)&nbsp;376-5776</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Fax: (888) 228-5672</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center">&nbsp;(Name, Address and
  Telephone Number of Agent for Service)</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; text-align: center; margin-bottom: 0pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Copy to:</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Thomas Slusarczyk, Esq.</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Barclay Damon, LLP</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>300 South State Street</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>Syracuse, New York 13202</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; padding: 0pt; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><B>(315) 235-2299</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in">Indicate by check mark
  whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
  See the definitions of &ldquo;large accelerated filer,&rdquo; &ldquo;accelerated filer&rdquo; and &ldquo;smaller reporting company&rdquo;
  in Rule 12b-2 of the Exchange Act. (Check one):</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 6%">&nbsp;</TD>
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif; width: 25%"><FONT STYLE="font-family: Times New Roman, Times, Serif">Large
      accelerated filer </FONT></TD>
      <TD STYLE="width: 22%; font: 10pt Times New Roman, Times, Serif">&#9744;</TD>
      <TD STYLE="vertical-align: top; width: 25%; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Accelerated
  filer </FONT></TD>
      <TD STYLE="width: 22%">&#9746;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD>&nbsp;</TD>
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Non-accelerated
      filer </FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif">&#9744;<FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Smaller
  reporting company&nbsp;</FONT></TD>
      <TD>&#9744;</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD>&nbsp;</TD>
      <TD COLSPAN="3" STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">(Do not check if a smaller reporting company)</FONT></TD>
      <TD>&nbsp;</TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><B>&nbsp;</B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><B></B></P>
  
  <!-- Field: Page; Sequence: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><B></B></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><B>&nbsp;</B></P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 100%; padding-bottom: 1.5pt; font: 10pt Times New Roman, Times, Serif; text-align: center; border-bottom: Black 1.5pt solid"><B>CALCULATION&nbsp;OF&nbsp;REGISTRATION&nbsp;FEE</B></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: center; border-bottom: Black 1.5pt solid">Title of <BR>
  securities to <BR>
  be registered</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Amount to be registered (1)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Proposed maximum offering price per share (2)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Proposed maximum aggregate offering price (2)</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid">Amount of registration fee</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom">
      <TD>&nbsp;</TD><TD>&nbsp;</TD>
      <TD COLSPAN="2">&nbsp;</TD><TD>&nbsp;</TD><TD>&nbsp;</TD>
      <TD COLSPAN="2">&nbsp;</TD><TD>&nbsp;</TD><TD>&nbsp;</TD>
      <TD COLSPAN="2">&nbsp;</TD><TD>&nbsp;</TD><TD>&nbsp;</TD>
      <TD COLSPAN="2">&nbsp;</TD><TD>&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="width: 52%">Common Stock $0.001 par value (3)</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right"><P STYLE="margin: 0">1,611,769</P>
  
  
  </TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">$</TD><TD STYLE="width: 9%; text-align: right">4.98</TD><TD STYLE="width: 1%; text-align: left"></TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">$</TD><TD STYLE="width: 9%; text-align: right">8,026,615</TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">$</TD><TD STYLE="width: 9%; text-align: right">808.28</TD><TD STYLE="width: 1%; text-align: left"></TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: right; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: right; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: right; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: right; border-bottom: Black 1.5pt solid">&nbsp;</TD><TD STYLE="text-align: left; padding-bottom: 1.5pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="padding-bottom: 4pt">Total</TD><TD STYLE="padding-bottom: 4pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 4pt double">&nbsp;</TD><TD STYLE="text-align: right; border-bottom: Black 4pt double"><P STYLE="margin: 0">1,611,769</P>
  
  
  </TD><TD STYLE="text-align: left; padding-bottom: 4pt">&nbsp;</TD><TD STYLE="padding-bottom: 4pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 4pt double">$</TD><TD STYLE="text-align: right; border-bottom: Black 4pt double">4.98</TD><TD STYLE="text-align: left; padding-bottom: 4pt">&nbsp;</TD><TD STYLE="padding-bottom: 4pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 4pt double">$</TD><TD STYLE="text-align: right; border-bottom: Black 4pt double">8,026,615</TD><TD STYLE="text-align: left; padding-bottom: 4pt">&nbsp;</TD><TD STYLE="padding-bottom: 4pt">&nbsp;</TD>
      <TD STYLE="text-align: left; border-bottom: Black 4pt double">$</TD><TD STYLE="text-align: right; border-bottom: Black 4pt double">808.28</TD><TD STYLE="text-align: left; padding-bottom: 4pt">&nbsp;</TD></TR>
  </TABLE>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font: 9pt Times New Roman, Times, Serif">(1)&nbsp;&nbsp;&nbsp;This
  Registration Statement also covers additional shares of Relmada Therapeutics, Inc. common stock that may be issuable by reason
  of stock splits, stock dividends, or other adjustment provisions of the Relmada Therapeutics, 2014 Stock Option and Equity Incentive
  Plan, as amended, in accordance with Rule 416 under the Securities Act of 1933, as amended.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-size: 9pt">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-size: 9pt">(2)&nbsp;&nbsp;&nbsp;Estimated
  solely for the purpose of calculating the registration fee computed pursuant to Rule 457(c) and (h), upon the basis of the average
  of the high and low prices of the common stock as quoted on OTCQB on September 29, 2015.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-size: 9pt">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-size: 9pt">(3)&nbsp;&nbsp;&nbsp;Represents
  the number of shares of Common Stock issuable upon the exercise of (a) currently outstanding stock options granted
  pursuant to the Relmada Therapeutics 2014 Stock Option and Equity Incentive Plan, as amended, and (b) stock options and other awards
  that are expected to be granted pursuant to the Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan,
  as amended.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify">&nbsp;</P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>EXPLANATORY
  NOTE</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: left"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  
  <P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">This
  Form S-8 relates to (i) the offer and resale of up to an aggregate of 847,147 shares of common stock, par value $0.001 per share
  (the &ldquo;Common Stock&rdquo;), of Relmada Therapeutics, Inc., a Nevada corporation (the &ldquo;Company&rdquo;), consisting
  of restricted shares of the Company&rsquo;s Common Stock previously issued under the Relmada Therapeutics, Inc. 2014 Stock Option
  and Equity Incentive Plan, as amended (the &ldquo;Plan) as well as shares of the Company&rsquo;s Common Stock underlying outstanding
  options previously granted under the Plan, (ii) options that may be granted under the Plan to purchase up to an aggregate of 764,622
  shares of the Company&rsquo;s Common Stock, and (iii) up to an aggregate of 764,622 shares of Common Stock of the Company, which
  may underlie options to be granted under the Plan, or which may be stock or other awards which are subject to future grants under
  the Plan.&nbsp;&nbsp;This Registration Statement contains two parts. First, the materials that follow Part I up to Part II of
  this Registration Statement constitute the reoffer prospectus, prepared in accordance with Part I of Form S-3, in accordance with
  General Instruction C of Form S-8, covering resales of &ldquo;restricted securities&rdquo; or &ldquo;control securities&rdquo;
  (as defined in General Instruction C of Form S-8). Such resale prospectus relates to shares of the Common Stock of the Company,
  and together with its subsidiaries, (&ldquo;we&rdquo;, &ldquo;our&rdquo; and &ldquo;us&rdquo;) previously issued to certain of
  our employees pursuant to the Plan. The amount of shares to be reoffered or resold by means of the reoffer prospectus contained
  herein by each selling stockholder, and any other person with whom such selling stockholder is acting in concert for the purpose
  of selling securities of the Company, may not exceed, during any three-month period, the amount specified in Rule 144(e) of the
  Securities Act of 1933, as amended (the &ldquo;Securities Act&rdquo;). The second part contains information required to be set
  forth in the registration statement pursuant to Part II of Form S-8.</P>
  
  
  
  <P STYLE="font: 10pt/normal Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>PART
  I</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>INFORMATION
  REQUIRED IN THE SECTION 10(a) PROSPECTUS*</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.5in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Item&nbsp;1.</B></FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Plan Information.*</B></FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.5in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Item&nbsp;2.</B></FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Registrant Information
      and Employee Plan Annual Information.**</B></FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.5in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">*</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The documents containing
      the information specified in Part I of Form S-8 will be sent or given to plan participant as specified in Rule 428(b)(1) of
      the Securities Act. Such documents need not be filed with the Securities and Exchange Commission (the &ldquo;Commission&rdquo;)
      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 Registration Statement, taken together, constitute a prospectus that meets the requirements of Section 10(a) of
      the Securities Act.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.5in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">**</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Upon written or oral
      request, any document incorporated by reference in Item 3 of Part II of this Registration Statement (which documents are incorporated
      by reference in this Section 10(a) prospectus), and any document required to be delivered to a participant in the Plans pursuant
      to Rule 428(b) or additional information about the Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan
      is available, without charge, by contacting the Company at:</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 100%; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Relmada Therapeutics,
      Inc.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">757
  Third Avenue, Suite 2018</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">New York, New York 10017</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 100%; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">Attention: Sergio Traversa,
      Tel: (212) 376-5741</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 100%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Reoffer Prospectus</B></FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font: 18pt Times New Roman, Times, Serif"><B>RELMADA
      THERAPEUTICS, INC.</B></FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><B>847,147 Shares of Common
  Stock</B></P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify">This reoffer prospectus relates
  to the offer and resale of up to an aggregate of 847,147 shares of common stock, par value $0.001 per share, of Relmada Therapeutics,
  Inc. a Nevada corporation, underlying outstanding options previously granted under the Relmada Therapeutics, Inc. 2014 Stock Option
  and Equity Incentive Plan, as amended. The shares of common stock subject to this prospectus may be offered and sold from time
  to time by the selling stockholders listed in this prospectus after the filing of the related registration statement on Form S-8.
  This prospectus has been prepared for the purpose of registering future sales of the shares of common stock by the selling stockholders,
  on a continuous or delayed basis, to the public without restriction. Upon the effectiveness of the related registration statement,
  the selling stockholders may offer these shares for resale for his/her own account from time to time.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  selling stockholders may sell the shares of common stock covered by this prospectus through various means, including directly
  or indirectly to purchasers, in one or more transactions on any stock market on which such shares are traded at the time of sale,
  in privately negotiated transactions, or through a combination of these methods. The selling stockholders selling any shares pursuant
  to this prospectus may be deemed to be an &ldquo;underwriter&rdquo; within the meaning of the Securities Act of 1933, as amended.
  Any commissions received by a broker or dealer in connection with resales of shares may be deemed to be underwriting commissions
  or discounts under the Securities Act. For additional information on the selling stockholders&rsquo; possible methods of sale,
  you should refer to the section in this prospectus entitled &ldquo;Plan of Distribution.&rdquo;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  will not receive any proceeds from the sale of the shares of common stock being offered by the selling stockholders. We will pay
  all of the expenses associated with this prospectus. Brokerage commissions and similar selling expenses, if any, attributable
  to the offer or sale of the shares of common stock covered by this prospectus will be borne by the respective selling stockholders.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify">Our common stock is quoted
  on OTCQB under the symbol &ldquo;RLMD.&rdquo; On September 29, 2015, the closing price of our common stock on such market was
  $4.35 per share.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>An
  investment in our securities is highly speculative, involves a high degree of risk and should be considered only by persons
  who can afford the loss of their entire investment. Please see &ldquo;Risk Factors&rdquo; beginning on page <A HREF="#a_004">12</A>  of this
  prospectus.</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Neither
  the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
  determined whether this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center">The date of this Prospectus
  is October 2, 2015.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
  <!-- Field: Page; Sequence: 5 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">&nbsp;</TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"></P>
  
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><A NAME="toc"></A><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>TABLE
  OF CONTENTS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_001"><FONT STYLE="font-family: Times New Roman, Times, Serif">ABOUT THIS PROSPECTUS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; width: 0.6in; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">i</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_002"><FONT STYLE="font-family: Times New Roman, Times, Serif">FORWARD-LOOKING STATEMENTS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">i</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_003"><FONT STYLE="font-family: Times New Roman, Times, Serif">PROSPECTUS SUMMARY</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">1</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_004"><FONT STYLE="font-family: Times New Roman, Times, Serif">RISK FACTORS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif">12</TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_005"><FONT STYLE="font-family: Times New Roman, Times, Serif">USE OF PROCEEDS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">33</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_006"><FONT STYLE="font-family: Times New Roman, Times, Serif">SELLING STOCKHOLDERS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">34</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_007"><FONT STYLE="font-family: Times New Roman, Times, Serif">PLAN OF DISTRIBUTION</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">36</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_008"><FONT STYLE="font-family: Times New Roman, Times, Serif">LEGAL MATTERS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif">3<FONT STYLE="font-family: Times New Roman, Times, Serif">7</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_009"><FONT STYLE="font-family: Times New Roman, Times, Serif">EXPERTS</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif">3<FONT STYLE="font-family: Times New Roman, Times, Serif">7</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_010"><FONT STYLE="font-family: Times New Roman, Times, Serif">WHERE YOU CAN FIND MORE INFORMATION</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif">3<FONT STYLE="font-family: Times New Roman, Times, Serif">7</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_011"><FONT STYLE="font-family: Times New Roman, Times, Serif">INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">37</FONT></TD></TR>
  <TR STYLE="background-color: white; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: bottom; text-align: right; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="background-color: #CCEEFF; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif"><A HREF="#a_012"><FONT STYLE="font-family: Times New Roman, Times, Serif">DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES</FONT></A></TD>
      <TD STYLE="vertical-align: bottom; text-align: center; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">38</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  
  <DIV STYLE="padding: 2px; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 10pt 0pt 0pt; padding: 0pt; text-align: center"><A NAME="a_001"></A><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>ABOUT
  THIS PROSPECTUS</B></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">You
  should rely only on the information contained in or incorporated by reference into this prospectus. We have not authorized any
  other person to provide you with additional information or information different from that contained in or incorporated by reference
  into this prospectus. The selling stockholders may, from time to time, offer to sell shares of our common stock only in jurisdictions
  where the offer or sale is permitted. You should not assume that the information contained in this prospectus is accurate as of
  any date other than the date on the front cover of this prospectus or that the information contained in any document incorporated
  by reference into this prospectus is accurate as of any date other than the date of the document incorporated by reference.</FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><A NAME="a_002"></A><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>FORWARD-LOOKING
  STATEMENTS</B></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">This
  prospectus and other documents we file with the Commission contain forward-looking statements, such as statements concerning our
  expected results of operations, financial resources or our projected plans for the expansion of our business, as well as other
  estimates relating to future operations. Words or phrases of expectation or uncertainty like &ldquo;expect,&rdquo; &ldquo;believe,&rdquo;
  &ldquo;continue,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;estimate,&rdquo; &ldquo;may,&rdquo; &ldquo;will,&rdquo; &ldquo;could,&rdquo;
  &ldquo;opportunity,&rdquo; &ldquo;future,&rdquo; &ldquo;project,&rdquo; &ldquo;can,&rdquo; &ldquo;intend,&rdquo; &ldquo;plan,&rdquo;
  &ldquo;potential,&rdquo; &ldquo;predict&rdquo;, the negative of these terms or variations of such words and similar expressions
  are intended to identify &ldquo;forward-looking statements,&rdquo; although not all forward-looking statements contain these identifying
  words. Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot
  guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors,
  including the risks outlined under &ldquo;Risk Factors&rdquo; or elsewhere in this prospectus, which may cause our or our industry&rsquo;s
  actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover,
  we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for
  us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor,
  or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
  All forward-looking statements included in this document are based on information available to us on the date hereof, and we assumes
  no obligation to update any such forward-looking statements.</FONT></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: center"><A NAME="a_003"></A><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>PROSPECTUS
  SUMMARY</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>&nbsp;</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>The
  following summary contains basic information about Relmada Therapeutics, Inc. and this prospectus. It may not contain all of the
  information that is important to you. For a more complete understanding, we encourage you to read the entire prospectus and the
  documents incorporated by reference into this prospectus. In this prospectus, the words &ldquo;Company,&rdquo; &ldquo;we,&rdquo;
  &ldquo;our&rdquo; and &ldquo;us&rdquo; refer to Relmada Therapeutics, Inc. and our subsidiary.</I></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>&nbsp;</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>&nbsp;The
  Securities and Exchange Commission allows us to &ldquo;incorporate by reference&rdquo; certain information that we file with it,
  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 this information. Any statement contained in this prospectus or 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 which 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 the notes
  to those statements appearing elsewhere in this prospectus or incorporated herein by reference.</I></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;<B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Company
  Overview</B></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Relmada
  Therapeutics, Inc. (&ldquo;Relmada&rdquo; or the &ldquo;Company&rdquo;) is a clinical stage biopharmaceutical company focused
  on developing a pipeline of drug candidates to treat chronic pain.&nbsp;Chronic pain is often defined as any pain lasting more
  than 12 weeks. Whereas acute pain is a normal sensation that alerts us to possible injury, chronic pain persists &ndash; often
  for months or even longer. Chronic pain may arise from an initial injury, such as back sprain, or there may be an ongoing cause,
  such as an illness. Sometimes there is no clear cause. According to the National Institutes of Health, approximately 100 million
  people in the U.S. are living with chronic pain.</FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  intend to realize our business objectives by implementing two core strategies to address unmet medical needs in the treatment
  of chronic pain: a) developing improved versions of proven drug candidates; and b) developing new chemical entities. This two
  tiered approach is expected to reduce overall clinical development investment, time, and risks. Our drug candidates are designed
  to improve the overall benefits and use of a drug for patients by improving the metabolism, distribution, pharmacokinetics, pharmacodynamics,
  half-life and/or bioavailability of drugs.</FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>d-Methadone
  (dextromethadone, REL-1017)</B></FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  most-advanced new chemical entity, d-Methadone (dextromethadone, REL-1017), is a novel, N-methyl-D-aspartate (NMDA) receptor antagonist
  being developed for the treatment of neuropathic pain. As a single isomer of racemic methadone, d-Methadone has been shown to
  possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA
  receptors has been associated with neuropathic pain and it is expected that d-Methadone will have a role in pain management by
  blocking this activity. In contrast, racemic methadone is a long-acting narcotic producing typical opioid side effects used in
  the treatment of various pain states and as a substitution therapy in opioid addiction. In November 2014, Health Canada approved
  a Clinical Trial Application (&ldquo;CTA&rdquo;) to conduct the first Phase I study with d-Methadone. This is a Single Ascending
  Dose (&ldquo;SAD&rdquo;) study that will be followed by a Multiple Ascending Dose (&ldquo;MAD&rdquo;) study, both in healthy volunteers.
  The two studies are designed to assess the safety, tolerability and pharmacokinetics of d-Methadone in healthy subjects. The SAD
  study includes single escalating oral doses of d-Methadone to determine the maximum tolerated dose. In the MAD study, healthy
  subjects are to receive daily oral doses of d-Methadone for several days to assess its safety, pharmacokinetics and tolerability.
  In March 2015, d-Methadone demonstrated a safe profile with no dose limiting side effects after four cohorts were exposed to increasing
  higher doses. In April 2015, the Company received clearance from Health Canada to continue with dose escalation and explore higher
  doses of d-Methadone. In June 2015, the Company successfully completed the SAD study and subsequently received a No Objection
  Letter (NOL) from Health Canada to conduct the MAD clinical study in August 2015. The data from these studies will inform the
  design of a subsequent Phase II proof of concept study.</FONT></P>
  
  <P STYLE="font: 8pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Ketamine
  hydrochloride (ketamine), an NMDA receptor antagonist, is an U.S. Food and Drug Administration (&ldquo;FDA&rdquo;) FDA-approved,
  rapid-acting general anesthetic that also produces strong analgesia in neuropathic pain states. The NMDA receptor is an excitatory
  glutamatergic receptor present at spinal and supraspinal sites and involved in the afferent transmission of nociceptive signals.
  In chronic pain states prolonged nociceptive stimulation causes activation and upregulation of the NMDA receptor at dorsal horn
  synapses resulting in enhanced and amplified trafficking of pain signals to the brain (central sensitization). This phenomenon
  is an important factor in the process of perseverance of pain. There is now ample evidence that NMDA receptor antagonists that
  block the NMDA receptor, such as ketamine, are able to halt the excessive barrage of nociceptive input to the brain and are therefore
  potential alternatives to existing treatments of chronic pain syndromes. The potential for widespread therapeutic use of ketamine
  is severely limited by its potential for abuse, dissociative and psychosis-like side effects. Orally-available d-Methadone is
  among the new generation of pain medications with potential to deliver ketamine-like palliative effects, without ketamine&rsquo;s
  side effects.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>LevoCap
  ER (REL-1015)</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  most-advanced novel version of a proven drug product, LevoCap ER (REL-1015), is an extended release, abuse deterrent, proprietary
  formulation of the opioid analgesic levorphanol, which is pharmacologically differentiated from morphine, oxycodone, and other
  strong opioids for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. In particular,
  levorphanol binds to all three opioid receptor subtypes involved in analgesia (mu, kappa, and delta), the N-methyl-D-aspartate
  (NMDA) receptor and the norepinephrine and serotonin uptake pumps, whereas morphine is relatively selective for mu sites. The
  dual mechanism of action of levorphanol, combining opioid receptor agonism with noradrenaline reuptake inhibition in the same
  molecule makes levorphanol a useful analgesic to treat chronic and neuropathic pain in addition to providing pain relief in patients
  resistant to other strong opioids. Levorphanol is a strong opioid first synthesized decades ago and is considered equal in potency
  to hydromorphone, oxycodone, fentanyl, and methadone. In clinical studies, it has demonstrated a remarkably broad spectrum of
  analgesic activity against many different types of pain including neuropathic pain, post-surgical pain, and chronic pain in patients
  refractory to other opioids. We continue to scale up manufacturing and prepare for Phase III development program and are planning
  to submit a request to the FDA to discuss the final regulatory and clinical plan for this product. In preparation for pivotal
  trial(s) that we plan to perform under US IND, we are selecting the final formulation and are planning to generate the necessary
  GMP batches.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>BuTab
  (REL-1028)</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  second-most-advanced novel version of a proven drug product, BuTab (REL-1028), represents novel formulations of oral, modified
  release buprenorphine being developed for both chronic pain and opioid dependence indications. Buprenorphine is a partial opioid
  agonist that has been widely used by the sublingual and transdermal routes of administration, but was believed to be ineffective
  by the oral route. We have completed a preclinical program to better define the pharmacokinetic profile of BuTab and to assess
  the time course of systemic absorption of buprenorphine using several different oral modified release formulations of buprenorphine
  in dogs, compared to an intravenous administration. Based on the results of this work, we have obtained approval from Health Canada
  to initiate a Phase I pharmacokinetic study in healthy volunteers in the second quarter of 2015. This trial is ongoing.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>Chronic
  Pain Indication </I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  first buprenorphine formulation for the treatment of chronic pain was approved in 2010. Purdue Pharmaceuticals received FDA approval
  for Butrans&reg; (buprenorphine transdermal system) in July. Butrans&reg; is indicated for the management of moderate to severe
  chronic pain and delivers buprenorphine transdermally (through the skin) over a period of seven days. The approval of Butrans&reg;
  signaled the interest and approvability of new formulations of buprenorphine. It is our view that a traditional oral tablet that
  is ingested and absorbed through the intestine will make it a preferred formulation for a significant number of patients with
  chronic pain conditions. Butrans&reg; was launched in early 2011. Sales of Butrans&reg; in 2014 totaled over $192 million and
  continue to steadily grow. Other formulations of buprenorphine are in development for the treatment of pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  August 2014, the U.S. Drug Enforcement Administration (DEA) published in the Federal Register their final ruling moving hydrocodone
  combination products (such as Vicodin, Lortab, Norco, etc.) from Schedule III to the more-restrictive Schedule II, as recommended
  by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA&rsquo;s
  own evaluation of relevant data. As a result of the ruling, hydrocodone containing products are now classified in the same category
  (Schedule II) as morphine and oxycodone. As a result of the change to Schedule II, access to these products will be more restricted.
  Among other changes, written prescriptions will be required and refills will not be permitted. The ruling also conveyed findings
  that hydrocodone combination products have a higher risk of abuse and addiction compared to Schedule III products. The ruling
  went into full effect in October 2014.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Buprenorphine
  is one of the few remaining Schedule III opioids and has a lower risk of abuse and addiction compared to Schedule II opioids and
  thus will have fewer restrictions on dispensing. BuTab has the opportunity to provide a Schedule III option for the treatment
  of chronic pain and thus helping to replace the void left from the hydrocodone combination products. We believe the actions taken
  to restrict the use of hydrocodone combination products may markedly increase the utility and appeal of BuTab as it could address
  an important unmet medical need for Schedule III options.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  December 2014, BioDelivery Sciences and Endo Pharmaceuticals, Inc. announced the NDA submission for BELBUCA&trade; for moderate
  to severe chronic pain, which was accepted by FDA in February 2015. BELBUCA&trade; is subject to a ten month FDA review, which
  could result in an approval in the fourth quarter of 2015 and allow for product launch in early 2016.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><I>Opioid
  Addiction Indication</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Maintenance
  treatment with buprenorphine reduces the typical cravings and withdrawal symptoms associated with coming off opioid prescription
  painkillers and heroin. This allows the individual suffering from an addiction to opioids &ndash;along with counseling and support
  &ndash; to work toward recovery. On average, treatment lasts a couple months, reflecting relatively high dropout rates, but a
  significant number of people remain on buprenorphine treatment chronically, with nearly one-quarter of patients still on therapy
  after nine months.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  total market for buprenorphine containing products for opioid dependence approached $1.8 billion in 2014. The market has grown
  significantly as a result of the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin
  use, the growing number of physicians treating opioid dependence, and the inclusion of addiction treatment as an essential benefit
  in the Affordable Care Act.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  products currently marketed for this indication include Suboxone&reg;, a sublingual film formulation of buprenorphine and naloxone,
  a sublingual tablet, Zubsolv&reg;, and generic formulations of buprenorphine/naloxone tablets. Suboxone&reg; film, the market
  leader, achieved sales of nearly $1.2 billion in the U.S. in 2014. While maintaining its dominance as the market leader in the
  U.S., Suboxone&reg; film experienced a decline in sales and share due to increased use of generics and the availability of newer
  formulation of buprenorphine/naloxone. In December 2014, Reckitt Benckiser Group PLC, the manufacturer of Suboxone&reg; sublingual
  tablets and films, announced that they completed the spin-off of that company&rsquo;s pharmaceutical business (including the Suboxone&reg;
  brand) under the name Indivior PLC in order to allow the consumer goods group to focus on its consumer health and hygiene products.
  The Indivior business will focus on addiction treatment and closely related areas including opioid overdose, cocaine overdose
  and alcohol dependence. In September 2012, Reckitt Benckiser announced that it had notified the FDA that they would be voluntarily
  discontinuing the distribution of Suboxone&reg; tablets in the U.S. and subsequently halted further shipments in March 2013. The
  decision made by Reckitt Benckiser was reportedly due to accumulating data demonstrating significantly lower rates of accidental
  pediatric exposure with Suboxone&reg; films compared with their tablet formulation due to the child-resistant, unit-dose packaging
  of the film versus a multi-dose bottle for the tablets. Additionally, Reckitt Benckiser filed a Citizens Petition to request that
  the FDA require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement public
  health safeguards including child-resistant, unit-dose packaging to reduce the risk of pediatric exposure. FDA subsequently rejected
  the Citizens Petition in February 2013, which allowed for the approval of the first generic formulations of Suboxone&reg; tablets.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  actions taken by Reckitt Benckiser as well as patient preference for a film formulation of Suboxone&reg; resulted in significant
  conversion of the Suboxone&reg; market to the branded film formulation. In 2013, the sublingual film formulation of Suboxone&reg;
  accounted for over 95% of total Suboxone&reg; prescription sales.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Generic
  buprenorphine/naloxone tablet formulations were launched in early 2013 by Actavis and Amneal Pharmaceuticals and were followed
  by additional entrants including a generic formulation from Teva. The remaining prescription volume for Suboxone&reg; tablets
  was rapidly converted to generics; however, the impact of generic buprenorphine/naloxone tablets on Suboxone&reg; film sales has
  been somewhat limited to date. In 2014, generic buprenorphine/naloxone tablets accounted for 18% of total buprenorphine/naloxone
  sales. It is anticipated that additional generics may enter the market, though the timing is unclear.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  June 2014, BioDelivery Sciences received FDA approval for BUNAVAIL&reg; for the maintenance treatment of opioid dependence. BUNAVAIL&reg;
  contains the partial opioid agonist buprenorphine with naloxone, an opioid antagonist, included as an abuse deterrent. When used
  as directed, the naloxone is swallowed and minimally absorbed; however, if misused (ie, dissolved and injected), the naloxone
  rapidly precipitates withdrawal symptoms.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  terms of additional competition, Phase 3 trials were completed for Probuphine, a subcutaneous depot delivery system containing
  buprenorphine from Titan Pharmaceuticals. Results of clinical studies demonstrated efficacy and safety, and Probuphine was submitted
  for FDA review in October 2012. Probuphine was anticipated to address the needs of the subset of patients undergoing treatment
  for opioid dependence who are unable to maintain compliance with alternative formulations or those who may be at high risk for
  diversion. In December 2012, Titan announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl. The license
  grants Braeburn exclusive commercialization rights in the United States and Canada. In April 2013, the FDA issued a Complete Response
  Letter for Probuphine and requested additional data regarding its efficacy. An additional Phase 3 study assessing the efficacy
  and safety of Probuphine was initiated in April 2014. In June 2015, Titan announced that the Phase 3 study of Probuphine for opioid
  addiction met the primary endpoint, allowing for a resubmission of their NDA in late 2015 and potentially securing approval for
  the product in the first half of 2016. Given the need for surgical implantation and removal, Probuphine is not expected to be
  a significant competitive threat to BuTab.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">A
  sublingual tablet, referred to as Zubsolv&reg; or OX219, was approved by FDA in July 2013 and subsequently launched in September
  2013. Zubsolv&reg; is a sublingual formulation of buprenorphine/naloxone using Orexo&rsquo;s proprietary sublingual drug delivery
  technology. Orexo is a specialty pharmaceutical company with headquarters in Sweden. Orexo is developing treatments using their
  proprietary sublingual drug delivery technology, which includes the marketed product Abstral&reg; that delivers fentanyl for the
  treatment of breakthrough cancer pain. In July 2013 Orexo announced the establishment of a commercial partnership with Publicis
  Healthcare Solutions. In May 2014, Orexo announced a new partnership with InVentiv Health for Zubsolv in the U.S.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  sales efforts for Zubsolv&reg; are supported by a contract sales organization (Inventive Health) and the product is being marketed
  predominantly based on its claims of improved taste and faster dissolve time compared to Suboxone&reg;. Sales for Zubsolv&reg;
  in 2014 totaled approximately $52 million in the U.S and a prescription market share of just over 3%.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">While
  limited information is available, other formulations of buprenorphine may also be in early stages of development for the treatment
  of opioid dependence, including an oral capsule (NTC-510) from Nanotherapeutics, Inc. Three Phase 1 studies have been completed
  to date (two Phase 1a single dose pharmacokinetic studies and one Phase 1b, multidose pharmacokinetic study). It has been demonstrated
  that NTC-510 administered orally achieves appropriate serum buprenorphine concentrations for analgesia and could potentially be
  dosed once daily. Also in development is a sublingual spray formulation of buprenorphine/naloxone from Insys which completed a
  Phase 1 study and buprenorphine hemiadipate (RBP-6300) from Indivior, an oral abuse-deterrent formulation of buprenorphine prodrug
  using Capsugel drug delivery technology.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">While
  we anticipate that the market for buprenorphine/naloxone products for the treatment of opioid dependence will get increasingly
  more competitive, we believe BuTab would have significant appeal given its traditional oral route of administration. We also believe
  that the increased number of companies promoting the use of buprenorphine containing-products for opioid dependence has the potential
  to create greater awareness and help to further expand what is already a significant and growing market.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>MepiGel
  (REL-1021)</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  third-most-advanced novel version of a proven drug product, MepiGel (REL-1021), is a proprietary topical dosage form of the local
  anesthetic mepivacaine for the treatment of painful peripheral neuropathies, such as painful diabetic neuropathy, postherpetic
  neuralgia and painful HIV-associated neuropathy. Mepivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses
  that send pain signals to the brain. It is chemically related to bupivacaine but pharmacologically related to lidocaine. Mepivacaine
  is currently indicated for infiltration, nerve block and epidural anesthesia. Relmada has received two FDA Orphan Drug Designations
  for mepivacaine, one each for &ldquo;the treatment of painful HIV-associated neuropathy&rdquo; and for &ldquo;the management of
  postherpetic neuralgia,&rdquo; or PHN. We have selected the formulations to be advanced into clinical studies for MepiGel after
  the evaluation of results from in vitro and ex vivo studies comparing various topical prototypes of mepivacaine that were conducted
  by MedPharm Ltd, a specialist formulation development company recognized internationally for its expertise in topical and transdermal
  products. Relmada is planning single and multiple dose Phase I studies in healthy subjects with the selected MepiGel formulations.
  The data from these studies will inform the design of a subsequent Phase 2 proof of concept study in patients suffering from neuropathic
  pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Along
  with antidepressants, antiepileptic drugs (AEDs) are often used as a first-line therapy for PHN. The most commonly prescribed
  AEDs for PHN are gabapentin and pregabalin (Lyrica). The choice between them is mostly influenced by physicians&rsquo; preference
  for the more-favorable dosing attributes (less-frequent daily dosing, faster titration) of pregabalin in balance with price and
  accessibility. AEDs are commonly associated with side effects including somnolence, dizziness, and weight gain. If first-line
  AED or antidepressant monotherapy fails to provide acceptable pain relief, physicians initiate combination therapy. If AED/antidepressant
  combination therapy is not effective, physicians typically add a dual-acting opioid such as tramadol. For more-severe pain, physicians
  may add or switch to tapentadol ER (Nucynta ER). If pain persists with the addition of tramadol or tapentadol, physicians often
  switch to a more potent opioid analgesic (e.g., oxycodone) while maintaining AED and/or antidepressant therapy. Although some
  experts acknowledge that strong opioids can be quite effective for PHN, they generally reserve this drug class for refractory
  cases and/or those with high pain intensity. For some PHN patients, particularly those experiencing highly localized pain, physicians
  may prescribe the lidocaine 5% patch (Lidoderm). Pain specialists generally consider that lidocaine is particularly beneficial
  for localized pain, and many physicians prefer it to oral agents because it does not cause systemic side effects and is easy to
  administer. In many cases, the patch is used in combination with an oral first-line AED and/or antidepressant therapy.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Acorda
  Therapeutics is developing a concentrated (20%) topical liquid formulation of capsaicin (NP-1998 [formerly NGX-1998]) for the
  treatment of neuropathic pain. The product was formerly in development by NeurogesX, which licensed all U.S. rights as well as
  those of its 8% capsaicin patch (Qutenza) to Accorda in July 2013. Acorda is planning to launch a Phase 3 clinical trial of NP-1998
  in painful HIV (human immunodeficiency virus) peripheral neuropathy as the first potential indication for NP-1998. The company
  is also exploring the potential for additional indications, including painful diabetic neuropathy. In 2011, NeurogesX completed
  a Phase 2 trial in post herpetic neuralgia and results from the trial confirmed efficacy and safety. Teva and Xenon Pharmaceuticals
  are developing TV-45070 (formerly XEN402), a subtype selective ion channel inhibitor. TV-45070 has potentially broad application
  in nociceptive pain, including inflammatory pain, and neuropathic pain indications. TV-45070 is partnered with Teva in a milestone,
  royalty and co-promotion partnership. Using a topical (ointment) formulation of TV-45070, Teva has initiated a 300-patient Phase
  2b clinical trial in osteoarthritis, or OA, of the knee. In July 2015, it was reported that TV-45070 4% and 8% did not demonstrate
  statistically significant difference from placebo in efficacy endpoints in Phase 2b study in pain due to osteoarthritis of the
  knee. Teva is also developing topical TV-45070 in neuropathic pain indications, and is currently planning a Phase 2b clinical
  trial in patients with postherpetic neuralgia.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Research
  and Development Expenses</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">A
  significant portion of our operating expenses is related to research and development and we intend to maintain our strong commitment
  to research and development. Research and development expense for year ended June 30, 2015, for the six months ended June 30,
  2014 and for the year ended December 31, 2013 was approximately $7,872,400, $840,000 and $5,248,700, respectively.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Overview
  of the 505(b)(2) Regulatory Pathway</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  majority of our drug development pipeline is based on the application of drug delivery technologies and/or new dosage forms/indications
  to existing drugs for the creation of novel products. We then seek proprietary protection and FDA approval, and subsequently plan
  to commercialize these products ourselves or through partners. We believe that research and development efforts focused on novel
  dose forms of FDA approved drugs is less risky than attempting to discover new drugs, sometimes called new chemical entities (known
  as NCEs).</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">An
  important part of our strategy is the utilization of FDA&rsquo;s 505(b)(2) NDA process for approval. The 505(b)(2) new drug application
  (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy
  for many companies. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the
  Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication
  of studies already performed on a previously approved (&ldquo;reference&rdquo; or &ldquo;listed&rdquo;) drug; the section gives
  the FDA express permission to rely on data not developed by the NDA applicant.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">A
  505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval,
  such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.
  This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such
  as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.<BR>
  <BR>
  <B>Overview of Orphan Drug Status</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  accordance with laws and regulations pertaining to the Regulatory Agencies, a sponsor may request that the Regulatory Agencies
  designate a drug intended to treat a &ldquo;Rare Disease or Condition&rdquo; as an &ldquo;Orphan Drug.&rdquo; For example, in
  the United States, a &ldquo;Rare Disease or Condition&rdquo; is defined as one which affects less than 200,000 people in the United
  States, or which affects more than 200,000 people but for which the cost of developing and making available the product is not
  expected to be recovered from sales of the product in the United States. Upon the approval of the first NDA or BLA for a drug
  designated as an orphan drug for a specified indication, the sponsor of that NDA or BLA is entitled to 7 years of exclusive marketing
  rights in the United States unless the sponsor cannot assure the availability of sufficient quantities to meet the needs of persons
  with the disease. In Europe, this exclusivity is 10 years, and in Australia it is 5 years. However, orphan drug status is particular
  to the approved indication and does not prevent another company from seeking approval of an off-patent drug that has other labeled
  indications that are not under orphan or other exclusivities. Orphan drugs may also be eligible for federal income tax credits
  for costs associated with such as the disease state, the strength and complexity of the data presented, the novelty of the target
  or compound, risk-management approval and whether multiple rounds of review are required for the agency to evaluate the submission.
  There is no guarantee that a potential treatment will receive marketing approval or that decisions on marketing approvals or treatment
  indications will be consistent across geographic areas.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Properties</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  do not own any property. As of June 30, 2015, we have a commitment of $30,600 at our previous corporate office location. We temporarily
  moved our corporate office location and have a commitment of approximately $41,600 through September 30, 2015 at 757 Third Avenue,
  Suite 2018, New York, NY 10017. In June 2015, we entered into a seven year <FONT STYLE="background-color: white">and three months
  lease at 275 Madison Avenue, Suite 702, New York, NY 10016 for our corporate office location, with an annual rental rate commencing
  at approximately $312,600 per year for the period to commencing in October 2015 through September 2019. The annual rent will increase
  to approximately $341,600 commencing in October 2019 through the end of the lease term. </FONT>We also lease an office at Village
  Square Professional Building Two, 686 DeKalb Pike, Suite 202, Blue Bell, PA 19422 for approximately $3,100, expiring September,
  2017.&nbsp;We entered into a sublease agreement through September 2016 whereby a tenant will be reimbursing us $2,350 for rent
  per month.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Our
  Corporate History and Background</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  are a clinical stage biopharmaceutical company focused on developing a pipeline of drug candidates to treat chronic pain.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Relmada
  Therapeutics, Inc. (&ldquo;RTI&rdquo;), which was previously a private company commenced operations in May 2004, entered into
  a Merger Agreement with Medeor Inc. (&ldquo;Medeor&rdquo;) on December 31, 2013. This transaction occurred by the exchange of
  Medeor&rsquo;s shares, for RTI&rsquo;s common stock. Following the transaction, the corporate existence of Medeor ceased and RTI
  continued as the surviving corporation (the &quot;Merger&quot;). In connection with the Merger, each share of common stock of
  Medeor was converted into the right to receive a pro rata share of RTI&rsquo;s common stock based upon an exchange ratio. Medeor
  was developing d-Methadone.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  May 2014, RTI completed a Share Exchange with Camp Nine, Inc., a publicly traded Nevada corporation that was formed in May 2012.
  In July 2014, we changed the name of Camp Nine, Inc. to Relmada Therapeutics, Inc. At the Share Exchange, RTI shareholders exchanged
  10 shares of RTI common stock for one share of our common stock. As a result of the Share Exchange, RTI&rsquo;s shareholders acquired
  the majority of our issued and outstanding capital stock and RTI became our subsidiary.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  Share Exchange was accounted for as a &ldquo;reverse merger&quot; rather than a business combination, wherein Relmada is considered
  the acquirer for accounting and financial reporting purposes. The statement of operations reflects the activities of RTI from
  the commencement of its operations since inception. Unless the context suggests otherwise, when we refer in this Report to business
  and financial information for periods prior to the consummation of the Share Exchange, we are referring to the business and financial
  information of RTI.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">During
  the six months ended June 30, 2014, we changed our year-end to June 30 and increased its authorized common stock to 500,000,000
  shares and its authorized preferred stock to 200,000,000 shares of which 3,500,000 is designated for Class A preferred stock.
  On August 12, 2015, the Company completed a one-for-five reverse stock split in preparation for our proposed up-listing to NASDAQ
  Capital Markets reducing the authorized common share to 100,000,000 common shares. This Annual Report reflects a retroactive adjustment
  for the reverse stock split.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Currently,
  none of our drugs have been approved for sale in the United States or elsewhere. We have no commercial products nor do we have
  a sales or marketing infrastructure. In order to market and sell our products we must conduct clinical trials on patients and
  obtain regulatory approvals from appropriate regulatory agencies, like the FDA in the United States, and similar organizations
  elsewhere in the world.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had net loss of approximately
  $20,803,600, $21,336,000 and $19,871, 900 for the year ended June 30, 2015, for the six months ended June 30, 2014 and for the
  year ended the year ended December&nbsp;31,&nbsp;2013, respectively. At June 30, 2015, we have an accumulated deficit of approximately
  $76,122,200.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="margin: 0"></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="margin: 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Business
  Strategy</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  strategy is to leverage our considerable industry experience, understanding of pain markets and development expertise to identify,
  develop and commercialize product candidates with significant market potential that can fulfill unmet medical needs in the treatment
  of pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  plan to further develop our novel, proprietary drug products via the 505(b)(2) development pathway and also to gain exclusivity
  under the Hatch-Waxman Act for new indications and also orphan drug designation in certain indications. We plan to also generate
  intellectual property (IP) that will further protect our products from competition.&nbsp;As the drug d-Methadone is not an already
  approved product by the FDA, the regulatory pathway to approval will be the more traditional NDA development, which may consist
  of conducting a full clinical development program. We will continue to prioritize our product development activities after taking
  into account the resources we have available, market dynamics and potential for adding value. We will continue to outsource development
  of our products, while retaining scientific, operational and financial oversight and control.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  intend to seek and execute licensing and/or co-development agreements with companies capable of supporting the final stage development
  of the Company&rsquo;s products and their subsequent commercialization in the U.S. and international markets.&nbsp;We may also
  develop our own internal sales and marketing capabilities to commercialize some or all of our products to selected specialty medical
  segments in the U.S. while out-licensing sales and marketing for the international market.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  may in-license late-stage or approved drugs to accelerate the pathway to become a fully integrated pain specialty biopharmaceutical
  company with commercial capability. Alternatively, we might consider a trade sale of our products or the entire company if we
  deem that it is in the best interests of our shareholders.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Market
  Opportunity</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  pain market is well established, with many pharmaceutical companies marketing innovative products as well as generic versions
  of older, non-patent protected products. In 2014, according to data from IMS Health, there were 328 million pain prescriptions
  representing $13 billion in annual sales in the U.S.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Analgesics
  continue to be among the most widely prescribed medications and there is little to suggest that their preeminence will change
  in the near future, given the prominent role of pain in many diseases. Survey data indicate substantial patient dissatisfaction
  with current pain management modalities. According to the Chronic Pain in America Study published in 1999 by AAPM, APS, and Jansen
  and the Voice of Chronic Pain Survey by the American Pain Foundation in May 2006; only 55% of patients with chronic pain feel
  their pain is &ldquo;under control&rdquo; and only 23% believe their pain medications are &ldquo;very effective.&rdquo; According
  to IMS Health, the U.S. opioid market was worth approximately $8.3B in 2013, with ER (Extended Release) opioids accounting for
  approximately $4.8B in sales. Significant market value has been maintained in the presence of low-cost high-volume generics over
  the last two decades through the introduction of new products that were approved via the 505(b)(2) FDA approval route. These products
  are branded and differentiated formulations such as fixed dose combinations, extended-release products, transdermal patches, etc.
  and thus provide both market exclusivity and the possibility of a high price point. Per Decision Resources, the cost of therapy
  for branded ER opioids is approximately $11.00 per day versus generics which cost $3.00 per day. Our ER opioids LevoCap ER and
  BuTab are pharmacologically differentiated from commercially available immediate release (IR) opioids, including OxyContin&reg;,
  Embeda&reg;, Opana&reg; ER, Duragesic&reg;, Avinza&reg;, Kadian&reg;, Remoxy&reg; &amp; Exalgo&reg;. Many patients with neuropathic
  pain have suboptimal relief with monotherapy and treatment is frequently multimodal, involving use of two or more drugs from different
  pharmacologic classes. Our topical local anaesthetic mepivacaine and oral d-Methadone are anticipated to be used for the treatment
  of painful peripheral neuropathies. According to Decision Resources, the market for neuropathic pain drugs is expected to grow
  to $9.7B by 2018 in the U.S. According to GlobalData, the U.S. neuropathic pain market consists of approximately 4.7M patients
  and is expected to grow to more than 6.1M patients in 2018. d-Methadone is anticipated to compete with the current available therapies
  for neuropathic pain, including Cymbalta&reg; which had $5.1B in worldwide 2013 sales, according to Eli Lilly 2013 annual report
  Lyrica&reg; which had $4.6B in worldwide 2013 sales, according to Pfizer 2013 annual report and lidocaine patch which had $1.28B
  in U.S. 2014 sales, according to IMS Health including generics.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  orphan designated topical MepiGel is anticipated to compete with topical lidocaine patch with $1.28B according to ISM which includes
  generic drugs in U.S. 2014 sales and may also be used in combination with oral therapies for neuropathic pain. MepiGel is developed
  for the relief of pain associated with post-herpetic neuralgia which is the same indication as that of the topical Lidocaine patch.
  Hence, we believe that MepiGel is anticipated to compete with the Lidocaine patch. Lidocaine patch is the only topical local anaesthetic
  approved for the treatment of neuropathic pain. Lidocaine patch provides only modest pain relief in patients with postherpetic
  neuralgia. According to the March 2010 issue of UK National Institute of Health and Clinical Excellence (NICE) clinical guideline
  on neuropathic pain, there is a &ldquo;lack of evidence for the efficacy of topical lidocaine for treating neuropathic pain&rdquo;
  and topical lidocaine should be considered as &ldquo;third line&rdquo; treatment for neuropathic pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Intellectual
  Property Portfolio and Market Exclusivity</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  have secured Orphan Drug Designation from the FDA for MepiGel for &ldquo;the treatment of painful HIV-associated neuropathy&rdquo;
  and for &ldquo;the management of postherpetic neuralgia&rdquo; which would, upon NDA approval, carry 7-year FDA Orphan Drug marketing
  exclusivity. In the European Union, some of our products may be eligible up to 10 years of market exclusivity which includes 8
  years data exclusivity and 2 years market exclusivity. In addition to any granted patents, our products will be eligible for market
  exclusivity to run concurrently with the term of the patent for 3 years in the U.S. (Hatch Waxman plus pediatric exclusivity)
  and up to 10 years of in the E.U. We believe an extensive intellectual property estate of several patents will protect our technology
  and products once our patent applications for our products are approved.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  following is a summary of our patents and patent applications:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>Levorphanol:
  </U></B>These patent applications cover the Levorphanol product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application 12/223.327 filed 1/29/07, Abuse Resistant and Extended Release Formulations and Method of Use Thereof. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application 12/597,702 filed 4/28/08, Multimodal Abuse Resistant and Extended Release Opioid Formulations. Currently claims are
  allowed. Issued fee paid.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application 13/320,9889 filed 2/26/10, Extended Release Oral Pharmaceutical Compositions of 3-Hydroxy-N-Methylmorphinan and Method
  of Use. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>d-Methadone:
  </U></B>These patent and patent application cover the d-Methadone product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  No. 6,008,258 filed 1/21/98, d-Methadone, a Nonopioid Analgesic, Patent granted.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application 13/803,375 filed 3/14/13, d-Methadone for the Treatment of Psychiatric Symptoms. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>Buprenorphine:
  </U></B>This patent application covers the buprenorphine product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application 12/988,209 filed 3/9/09, Oral Pharmaceutical Compositions of Buprenorphine and Method of Use. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B><U>Mepivacaine</U></B>:
  This patent application covers the Mepivacaine product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Patent
  application PCT/US2011/032,381 filed 4/13/11, Dermal Pharmaceutical Composition of 1-Methyl-2&rsquo;,6&rsquo;-Pipecoloxylidide
  and Method of Use. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"></P>
  
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Key
  Strengths</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  believe that the key elements for our market success include:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.25in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 0.25in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">A multiple product portfolio with a balanced risk reward profile:
      We have four products at various stages of development, and each has its own development risk profile and indication. Accordingly,
      management believes that we are well positioned to become a competitive player in a large unsatisfied market.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Products are differentiated and address significant unmet needs:
      All four lead development programs are well differentiated value added pain drugs that address significant unmet medical needs.
      Pain management remains a critical area of unmet medical need. Increasingly, patients, advocacy groups, pain related professional
      organizations and the media are highlighting the limitations of pain management and are demanding changes in the medical system.
      Neuropathic pain in particular is a large and unsatisfied segment where d-Methadone could play an important role. In addition,
      the abuse potential of leading pain medications such as the OxyContin franchise, Vicodin, etc. has been reported extensively.
      Our LevoCap ER dosage form is designed to deter the manipulation for intravenous, intranasal or inhalational use, and for
      oral ingestion to provide high peak concentrations to opioid addicts and recreational drug users.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Scientific support of leading experts: Our scientific advisory
      board includes clinicians and scientists who are affiliated with a number of highly regarded medical institutions. The board
      consists of individuals who have served as executives of leading national and international societies in pain, rheumatology
      and the FDA.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Efficient development strategy: The 505(b) (2) pathway lowers
      the risk of drug development. Our strategy of combining proven drug candidates with novel delivery methods and pharmaceutical
      compositions reduces clinical development time and costs and lowers regulatory risks, while delivering valuable products in
      areas of high unmet need to the market place. Abuse resistant and once a day formulations improve the commercial potential
      of opioids, addressing the risk of opioid abuse and opioid diversion by making the dosage form tamper resistant, thereby frustrating
      attempts at physical manipulation of the dosage.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Substantial IP portfolio and market protection: Upon the approval
      of our filed patent applications for our products we will have secured an intellectual property portfolio comprised of several
      patents. In addition, some of our drugs have also been designated as Orphan Drugs by the FDA, thereby providing seven years
      of market exclusivity at launch.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Experienced management: We combine business expertise with what
      we believe is an internationally recognized research team. We believe our highly experienced drug development leadership provides
      us with a significant competitive advantage in designing highly efficient clinical programs with predictable regulatory outcomes.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Competition
  Overview</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  pharmaceutical and biotechnology industry is characterized by intense competition, rapid product development and technological
  change. Competition is intense among manufacturers of prescription pharmaceuticals and other product areas where we may develop
  and market products in the future. Most of our competitors are large, well established pharmaceutical or healthcare companies
  with considerably greater financial, marketing, sales and technical resources than are available to us. Additionally, many of
  our competitors have research and development capabilities that may allow such competitors to develop new or improved products
  that may compete with our products. Our products could be rendered obsolete or made uneconomical by the development of new products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Regarding
  our competitive position in the industry, none of our products have been approved for sale.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  pain market has peculiar characteristics with regards to competition. While there are several products in development both in
  the narcotic and neuropathic pain space, the market history has shown that a new entry in the therapeutic area does not necessarily
  cannibalize existing products, but instead expands the market. The reasons behind this behavior can be found in the &ldquo;opioid
  rotation&rdquo; phenomena. As there is considerable variability in the efficacy and side effect response of patients to opioid
  analgesics, many patients rotate from one opioid to another, offering growth opportunity to new entries. In the case of the neuropathic
  pain indication, it is mostly the limited efficacy of the existing therapies that creates a strong demand for new entries, a model
  also supported by the considerable off-label use of opioids, tricyclic antidepressant and NSAIDS in neuropathic pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Because
  of the large opportunity, the current competitive landscape includes a significant number of pharmaceutical companies such as
  Pfizer, Johnson &amp; Johnson, Eli Lilly, Endo Pharmaceutical Holding, Purdue Pharma, Mallinckrodt, DepoMed, and Teva Pharmaceutical.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  addition to the marketed drugs, we expect competition from product candidates that are or will be in development by the companies
  mentioned above and others. We are aware that several companies not mentioned before are working on new delivery forms of pain
  products and abuse deterrent formulations, including Acura Pharmaceutical, BioDelivery Science, Collegium Pharmaceutical, Egalet
  A/S, Elite Pharmaceutical, Inspirion Delivery Technologies, and Intellipharmaceutics International.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
  <!-- Field: Page; Sequence: 16; Value: 1 -->
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  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Government
  Regulation</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Governmental
  authorities in the United States and other countries extensively regulate, among other things, the research, development, testing,
  manufacture, labeling, promotion, advertising, distribution and marketing of active pharmaceutical ingredients, excipients, controlled
  substances and finished pharmaceutical products such as those being developed by Relmada.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">In
  the United States, the FDA regulates such products under the Federal Food, Drug and Cosmetic Act (FDCA), as amended and regulations
  pursuant to the FDCA.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  U.S. Drug Enforcement Agency (DEA), a division of the Department of Justice, administers the federal Controlled Substances Act
  (&ldquo;CSA&rdquo;) of 1970, as amended. The CSA imposes various registration, record-keeping and reporting requirements, procurement
  and manufacturing quotas, import and export controls, labeling and packaging requirements, security controls, and a restriction
  on prescription refills on certain pharmaceutical products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">To
  meet its responsibilities, the DEA conducts periodic inspections of registered establishments that handle controlled substances.
  Failure of companies to maintain compliance, particularly as manifested in loss or diversion, can result in regulatory action
  including civil and criminal penalties, refusal to renew necessary registrations, or initiating proceedings to revoke those registrations.
  If a manufacturer or distributor has its registration revoked, it can no longer lawfully possess or distribute controlled substances
  meaning effectively that the operations of such an organization must cease with respect to controlled substances. In certain circumstances,
  violations also can lead to criminal proceedings.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Most
  states impose similar controls over controlled substances under state law as regulated by the Board of Pharmacy or other state
  regulatory authorities.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">The
  U.S. Federal Trade Commission (FTC) and the Office of the Inspector General of the U.S. Department of Health and Human Services
  (HHS) also regulate certain pharmaceutical marketing practices. Thus, reimbursement practices of the HHS covering medicine and
  medical services are important to the success of our products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  are also subject to United States regulation under the Controlled Substances Act (&ldquo;CSA&rdquo;). Drug Enforcement Administration
  regulations require Scheduled II controlled substances to be manufactured in the United States if the products are to be marketed
  in the United States. Our only products that contain Schedule II controlled substances are LevoCap-ER and d-Methadone. We are
  in the process of transferring all third party manufacturing of these products to the United States, and we intend to comply with
  this CSA requirement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">We
  are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing
  practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Failure
  to comply with applicable FDA, DEA, FTC, HHS and other federal and state regulations and requirements, both before and after drug
  approval may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA to approve
  pending applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution,
  injunctions, fines and/or criminal prosecution.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Relmada
  believes that a two tiered approach can reduce overall clinical development risks. Our approach consists of: (1) developing improved
  versions of proven drug candidates and filings under 505(b)(2) which may require an abbreviated clinical development program;
  and (2) developing a drug in treating conditions that have not been approved by the FDA, and filings under the traditional NDA
  which would require a full clinical development program. In general, drugs for the 505(b)(2) filing possess less risks as compared
  to drugs filed under the traditional NDA route. As with all drugs filed with the FDA, there is no guarantee of approval.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Please
  see &ldquo;Company Overview&rdquo; above for a status of our drug development.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>U.S.
  Food and Drug Administration Regulation</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  research, development and clinical programs, as well as our manufacturing and marketing operations, are subject to extensive regulation
  in the United States and other countries. Most notably, all of our products sold in the United States are subject to the FDCA
  as implemented and enforced by the FDA. Certain of our product candidates in the United States require FDA pre-marketing approval
  of an NDA pursuant to 21 C.F.R. &sect; 314. Foreign countries may require similar or more onerous approvals to manufacture or
  market these products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 36pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify"><FONT STYLE="font-family: Times New Roman, Times, Serif">Failure
  by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA, the DEA
  or other regulatory authorities, which may result in sanctions including, but not limited to: untitled letters, warning letters,
  fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recall, detention
  or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying
  our requests for NDA premarket approval of new products or modified products; withdrawing NDA approvals that have already been
  granted; refusal to grant export approval for our products; or criminal prosecution.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Corporate
  Information</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Our
  principal executive office is located at 757 Third Avenue, New York, NY 10017 and our telephone number is (212) 376-5776. Our
  website address is<I> www.relmada.com.</I> Information accessed through our website is not incorporated into this prospectus
  and is not a part of this prospectus.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt">&nbsp;</P>
  
  </DIV>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"></P>
  
  <!-- Field: Page; Sequence: 17; Value: 1 -->
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      <!-- Field: /Page -->
  
  <DIV STYLE="padding-right: 5; padding-left: 5; border: Black 1.5pt solid; width: 99%">
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-align: justify; text-indent: 39.6pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>The
  Offering</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt; text-indent: 0.5in"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 40%; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Common stock offered by selling stockholders</B></FONT></TD>
      <TD STYLE="width: 2%; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 58%; text-align: justify; font: 10pt Times New Roman, Times, Serif">847,147<FONT STYLE="font-family: Times New Roman, Times, Serif">
  shares of our common stock (i) underlying outstanding options and restricted stock previously granted under the Relmada Therapeutics,
  Inc 2014 Stock Option and Equity Incentive Plan, as amended (the &ldquo;Plan&rdquo;) to the selling stockholders.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Use of proceeds</B></FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">We will not receive any proceeds
      from the sales of these shares. &nbsp;We will receive proceeds to the extent that options to purchase common stock may be
      issued and thereafter exercised. &nbsp;We will use the exercise proceeds, if any, for working capital and general corporate
      purposes.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Trading Symbol</B></FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">RLMD</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif"><B>Risk Factors</B></FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font-family: Times New Roman, Times, Serif">The common stock offered hereby involves
      a high degree of risk and should not be purchased by investors who cannot afford the loss of their entire investment. &nbsp;You
      should carefully consider the risk factors described in this prospectus in the &ldquo;Risk Factors&rdquo; section before making
      a decision to invest.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  </DIV>
  
  <!-- Field: Page; Sequence: 18; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt; padding: 0pt"><FONT STYLE="font-family: Times New Roman, Times, Serif"></FONT></P>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  <P STYLE="margin: 0pt; padding: 0pt; font: 10pt Times New Roman, Times, Serif">&nbsp;</P>
  
  <P STYLE="margin-top: 0; text-align: center; margin-bottom: 0; font: 10pt Times New Roman, Times, Serif"><A NAME="a_004"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>RISK
  FACTORS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>&nbsp;</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>An
  investment in our common stock involves a high degree of risk. You should carefully consider the risks described below, together
  with all of the other information included in this report, before making an investment decision. If any of the following risks
  actually occurs, our business, financial condition or results of operations could suffer. In that case, the trading price of our
  shares of common stock could decline, and you may lose all or part of your investment. You should read the section entitled &ldquo;Forward-Looking
  Statements&rdquo; above for a discussion of what types of statements are forward-looking statements, as well as the significance
  of such statements in the context of this prospectus.</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Risk
  Related to Our Business</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  product candidates are in early stages of clinical testing.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our product
  candidates are still in the early stages of clinical testing. None has gone beyond the Phase I/Phase IIa stage and FDA approval
  requires that a drug candidate complete a Phase III study program, to test the safety and efficacy of the drug candidate on a
  large sample of patients. The timeline between a Phase I study and a Phase III study and subsequent filing of a New Drug Application
  can be several years. We will need to commit substantial time and additional resources to conducting further nonclinical studies
  and clinical trials before we can submit an NDA with respect to any of these product candidates. We cannot predict with any certainty
  if or when we might submit an NDA for regulatory approval of any of our product candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have generated no revenue from commercial sales to date and our future profitability is uncertain.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We have
  a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise.
  Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently
  encountered in connection with this. Since we began our business, we have focused on research, development and clinical trials
  of product candidates, and have incurred significant losses since inception and generated no product revenues. If we continue
  to incur operating losses and fail to become a profitable company, we may be unable to continue our operations. We expect to continue
  to operate at a net loss for at least the next several years as we continue our research and development efforts, continue to
  conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities. There can be no assurance that
  the products under development by us will be approved for sales in the US or elsewhere. Furthermore, there can be no assurance
  that if such products are approved they will be successfully commercialized, and the extent of our future losses and the timing
  of our profitability are highly uncertain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>International
  commercialization of our product candidates faces significant obstacles.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We may plan
  to commercialize some of our products internationally through collaborative relationships with foreign partners. We have limited
  foreign regulatory, clinical and commercial resources. Future partners are critical to our international success. We may not be
  able to enter into collaboration agreements with appropriate partners for important foreign markets on acceptable terms, or at
  all. Future collaborations with foreign partners may not be effective or profitable for us. We will need to obtain approvals from
  the appropriate regulatory, pricing and reimbursement authorities to market any of our proposed products internationally, and
  we may be unable to obtain foreign regulatory approvals. Pursuing foreign regulatory approvals will be time-consuming and expensive.
  The regulations can vary among countries and foreign regulatory authorities may require different or additional clinical trials
  than we conducted to obtain FDA approval for our product candidates. In addition, adverse clinical trial results, such as death
  or injury due to side effects, could jeopardize not only regulatory approval, but if approval is granted, may also lead to marketing
  restrictions. Our product candidates may also face foreign regulatory requirements applicable to controlled substances.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  need to raise additional capital to operate our business</I></B><I>.</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>&nbsp;</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We are a
  company focused on product development and have not generated any product revenues to date. Until, and if, we receive approval
  from the FDA and other regulatory authorities for our product candidates, we cannot sell our drugs and will not have product revenues.
  Therefore, for the foreseeable future, we will have to fund all of our operations and capital expenditures from the net proceeds
  of future offerings and grants. We believe with our cash and cash equivalents on hand at June 30, 2015 of approximately $22,470,000
  we can fund our operations until the end of calendar year 2016. Our actual capital requirements will depend on many factors. If
  we experience unanticipated cash requirements, we may need to seek additional sources of financing, which may not be available
  on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete
  planned nonclinical studies and clinical trials or obtain approval of our product candidates from the FDA and other regulatory
  authorities. In addition, we could be forced to discontinue product development, reduce or forego sales and marketing efforts
  and attractive business opportunities, or discontinue operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have a history of losses and we may never achieve or sustain profitability.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We have
  incurred substantial losses since our inception, and we may not achieve profitability for the foreseeable future, if at all. We
  have incurred an accumulated loss of approximately $76,100,200, which includes non-cash expenses of approximately $47,565,700.
  The Company has cash and cash equivalents of approximately $22,470,000 at June 30, 2015. Even if we succeed in developing and
  commercializing one or more of our product candidates, we expect to incur substantial net losses and negative cash flows for the
  foreseeable future due in part to increasing research and development expenses, including clinical trials, and increasing expenses
  from leasing additional facilities and hiring additional personnel. As a result, we will need to generate significant revenues
  in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the
  future. Even if we do achieve profitability, we may not be able to sustain or increase profitability.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have a limited operating history upon which to base an investment decision.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our limited
  operating history may limit your ability to evaluate our prospects due to our limited historical financial data and our unproven
  potential to generate profits. You should evaluate the likelihood of financial and operational success in light of the risks,
  uncertainties, expenses and difficulties associated with an early-stage business, many of which may be beyond our control, including:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.25in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 0.25in; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">our potential
      inability to continue to undertake nonclinical studies, pharmaceutical development and clinical trials,</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">our potential
      inability to obtain regulatory approvals, and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">our potential
      inability to manufacture, sell and market our products.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our operations
  have been limited to organizing and staffing, on a limited basis, our company, acquiring, developing and securing our proprietary
  technology and undertaking nonclinical studies and early stage clinical trials of our principal product candidates. These operations
  provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing
  in our common stock.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development
  and you will likely lose your entire investment.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>&nbsp;</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We will
  need to continue to seek capital from time to time to continue for the development beyond of our product that are in Phase I and
  II clinical trials. We also may acquire and develop other product candidates. Our first product is not expected to be commercialized
  until at least 2018 and the revenues it will generate may not be sufficient to fund our ongoing operations. The Company believes
  that with current cash on hand it will be able to fund the Company&rsquo;s operations until end of calendar year 2016. Accordingly,
  we believe that we will need to raise substantial additional capital to fund our continuing operations and the development and
  commercialization of our product candidates in the second half of 2015. Our business or operations may change in a manner that
  would consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations,
  fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or otherwise respond
  to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred pain treatment
  modalities. In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently
  envisioned and this would require additional capital. However, we may not be able to secure funding when we need it or on favorable
  terms. If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale-back or eliminate our
  research and development activities, clinical studies or future operations. We may also be required to obtain funds through arrangements
  with collaborators, which arrangements may require us to relinquish rights to certain technologies or products that we otherwise
  would not consider relinquishing, including rights to future product candidates or certain major geographic markets. We may further
  have to license our technology to others. This could result in sharing revenues which we might otherwise retain for ourselves.
  Any of these actions may harm our business, financial condition and results of operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The amount
  of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;
  the progress, timing and scope of our nonclinical studies and clinical trials; the time and cost necessary to obtain regulatory
  approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our
  ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners&rsquo; commitment
  of time and resource to the development and commercialization of our products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on terms that
  are dilutive to you.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We have
  limited access to the capital markets to raise capital. The capital markets have been unpredictable in the recent past for other
  pain companies and unprofitable companies such as ours. In addition, it is generally difficult for companies to raise capital
  under current market conditions. The amount of capital that a company such as ours is able to raise often depends on variables
  that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we are
  able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds
  are not available on acceptable terms, or at all, our business, results of operations, financial condition and our continued viability
  will be materially adversely affected.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
  <!-- Field: Page; Sequence: 20; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Risks
  Related to Clinical and Regulatory Matters</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we or our potential collaborators fail to obtain the necessary regulatory approvals, or if such approvals are limited, we and
  our potential collaborators will not be allowed to commercialize our drug candidates, and we will not generate product revenues.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Satisfaction
  of all regulatory requirements for commercialization of a drug candidate typically takes many years, is dependent upon the type,
  complexity and novelty of the drug candidate, and requires the expenditure of substantial resources for research and development.
  Our research and clinical approaches may not lead to drugs that the FDA considers safe for humans and effective for indicated
  uses we are studying. The FDA may require additional studies, in which case we or our collaborators would have to expend additional
  time and resources and would likely delay the date of potentially receiving regulatory approval. The approval process may also
  be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur
  prior to or during our regulatory review. Delays in obtaining regulatory approvals would:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">delay commercialization
      of, and product revenues from, our drug candidates; and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">diminish the competitive
      advantages that we may have otherwise enjoyed, which would have an adverse effect on our operating results and financial condition.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Even if
  we or our collaborators comply with all FDA regulatory requirements, our drug candidates may never obtain regulatory approval.
  If we or our collaborators fail to obtain regulatory approval for any of our drug candidates we will have fewer commercial products,
  if any, and corresponding lower product revenues, if any. Even if our drug candidates receive regulatory approval, such approval
  may involve limitations on the indications and conditions of use or marketing claims for our products. Further, later discovery
  of previously unknown problems or adverse events could result in additional regulatory restrictions, including withdrawal of products.
  The FDA may also require us or our collaborators to commit to perform lengthy Phase IV post-approval clinical efficacy or safety
  studies. Our expending additional resources on such trials would have an adverse effect on our operating results and financial
  condition.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In jurisdictions
  outside the United States, we or our collaborators must receive marketing authorizations from the appropriate regulatory authorities
  before commercializing our drugs. Regulatory approval processes outside the United States generally include all of the aforementioned
  requirements and risks associated with FDA approval.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we or our collaborators are unable to design, conduct and complete clinical trials successfully, our drug candidates will not
  be able to receive regulatory approval.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In order
  to obtain FDA approval for any of our drug candidates, we or our collaborators must submit to the FDA an NDA that demonstrates
  with substantive evidence that the drug candidate is both safe and effective in humans for its intended use. This demonstration
  requires significant research and animal tests, which are referred to as preclinical studies, as well as human tests, which are
  referred to as clinical trials.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Results
  from Phase I clinical programs may not support moving a drug candidate to Phase II or Phase III clinical trials. Phase III clinical
  trials may not demonstrate the safety or efficacy of our drug candidates. Success in preclinical studies and early clinical trials
  does not ensure that later clinical trials will be successful. Results of later clinical trials may not replicate the results
  of prior clinical trials and preclinical studies. Even if the results of Phase III clinical trials are positive, we or our collaborators
  may have to commit substantial time and additional resources to conducting further preclinical studies and clinical trials before
  obtaining FDA approval for any of our drug candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Clinical
  trials are very expensive and difficult to design and implement, in part because they are subject to rigorous requirements. The
  clinical trial process also consumes a significant amount of time. Furthermore, if participating patients in clinical trials suffer
  drug-related adverse reactions during the course of such clinical trials, or if we, our collaborators or the FDA believe that
  participating patients are being exposed to unacceptable health risks, such clinical trials will have to be suspended or terminated.
  Failure can occur at any stage of the clinical trials, and we or our collaborators could encounter problems that cause abandonment
  or repetition of clinical trials.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our clinical
  trials and our future clinical trials for other drug candidates for treatment of pain measure clinical symptoms, such as pain
  and physical dependence that are not biologically measurable. The success in clinical trials and our other drug candidates designed
  to reduce risks of unintended use depends on reaching statistically significant changes in patients&rsquo; symptoms based on clinician-rated
  scales. Due in part to a lack of consensus on standardized processes for assessing clinical outcomes, these scores may or may
  not be reliable, useful or acceptable to regulatory agencies.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We have
  no history of developing drug candidates. We do not know whether any of our planned clinical trials will result in marketable
  drugs.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  completion of clinical trials can be delayed by numerous factors, including:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">delays in identifying
      and agreeing on acceptable terms with prospective clinical trial sites;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">slower than expected
      rates of patient recruitment and enrollment;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">unanticipated
      patient dropout rates;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">increases in time
      required to complete monitoring of patients during or after participation in a clinical trial; and</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"></P>
  
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Any of these
  delays could significantly impact the timing, approval and commercialization of our drug candidates and could significantly increase
  our overall costs of drug development.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Even if
  clinical trials are completed as planned, their results may not support expectations or intended marketing claims. The clinical
  trials process may fail to demonstrate that our drug candidates are safe and effective for indicated uses. Such failure would
  cause us to abandon a drug candidate and could delay development of other drug candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>With
  respect to the Phase III clinical trial, these discussions are not binding obligations on the part of regulatory authorities.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Regulatory
  authorities may revise previous guidance or decide to ignore previous guidance at any time during the course of our clinical activities
  or after the completion of our clinical trials. Even with successful clinical safety and efficacy data, including such data from
  a clinical trial conducted pursuant to an SPA, we or our collaborators may be required to conduct additional, expensive clinical
  trials to obtain regulatory approval.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Developments
  by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Changes
  in standards related to clinical trial design could affect our ability to design and conduct clinical trials as planned. For example,
  regulatory authorities may not allow us to compare our drug candidates to placebo in a particular clinical indication where approved
  products are available. In that case, both the cost and the amount of time required to conduct a clinical trial could increase.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>The
  DEA limits the availability of the active ingredients in certain of our current drug candidates and, as a result, quotas for these
  ingredients may not be sufficient to complete clinical trials, or to meet commercial demand or may result in clinical delays.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The U.S.
  Drug Enforcement Administration, or DEA, regulates chemical compounds as Schedule I, II, III, IV or V substances, with Schedule
  I substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. Certain active
  ingredients in our current drug candidates, such as oxycodone, are listed by the DEA as Schedule II under the Controlled Substances
  Act of 1970. Consequently, their manufacture, research, shipment, storage, sale and use are subject to a high degree of oversight
  and regulation. For example, all Schedule II drug prescriptions must be signed by a physician, physically presented to a pharmacist
  and may not be refilled without a new prescription. Furthermore, the amount of Schedule II substances that can be obtained for
  clinical trials and commercial distribution is limited by the DEA and quotas for these substances may not be sufficient to complete
  clinical trials or meet commercial demand. There is a risk that DEA regulations may interfere with the supply of the drugs used
  in clinical trials for our product candidates, and, in the future, the ability to produce and distribute our products in the volume
  needed to meet commercial demand.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Conducting
  clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensive product liability claims
  and we may not be able to maintain product liability insurance on reasonable terms or at all.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The risk
  of product liability is inherent in the testing of pharmaceutical products. If we cannot successfully defend ourselves against
  product liability claims, we may incur substantial liabilities or be required to limit or terminate testing of one or more of
  our drug candidates. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against product
  liability claims could prevent or inhibit the commercialization of our drug candidates. We currently carry clinical trial insurance
  but do not carry product liability insurance. If we successfully commercialize one or more of our drug candidates, we may face
  product liability claims, regardless of FDA approval for commercial manufacturing and sale. We may not be able to obtain such
  insurance at a reasonable cost, if at all. Even if our agreements with any current or future corporate collaborators entitle us
  to indemnification against product liability losses, such indemnification may not be available or adequate should any claim arise.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  our drug candidates receive regulatory approval, we and our collaborators will also be subject to ongoing FDA obligations and
  continued regulatory review, such as continued safety reporting requirements, and we and our collaborators may also be subject
  to additional FDA post-marketing obligations or new regulations, all of which may result in significant expense and limit our
  and our collaborators&rsquo; ability to commercialize our drugs.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Any regulatory
  approvals that our drug candidates receive may also be subject to limitations on the indicated uses for which the drug may be
  marketed or contain requirements for y costly post-marketing follow-up studies. In addition, if the FDA approves any of our drug
  candidates, the labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping for the drug
  will be subject to extensive regulatory requirements. The subsequent discovery of previously unknown problems with the drug, including
  but not limited to adverse events of unanticipated severity or frequency, or the discovery that adverse events previously observed
  in preclinical research or clinical trials that were believed to be minor actually constitute much more serious problems, may
  result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The FDA&rsquo;s
  policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our
  drug candidates. For example, on July&nbsp;9, 2012, the FDA approved a risk management program, known as a Risk Evaluation and
  Mitigation Strategy, or REMS, for extended-release and long-acting opioid analgesics, or ER/LA opioid analgesics. This REMS will
  require companies affected by the REMS to make available training for health care professionals who prescribe ER/LA opioid analgesics
  on proper prescribing practices and also to distribute educational materials to prescribers and patients on the safe use of ER/LA
  opioid analgesics.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We cannot
  predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative
  action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we may be subject to fines,
  suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
  Any of these events could prevent us from marketing our drugs and our business could suffer drug candidates and we will not become
  competitive with our drug candidates being developed. If time and resources devoted are limited or there is a failure to fund
  the continued development other opioid drug candidates or there is otherwise a failure to perform as we expect, we may not achieve
  clinical and regulatory milestones and regulatory submissions and related product introductions may be delayed or prevented, and
  revenues that we would receive from these activities will be less than expected.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We may depend
  on independent investigators and collaborators, such as universities and medical institutions, to conduct our clinical trials
  under agreements with us. These investigators and collaborators are not our employees and we cannot control the amount or timing
  of resources that they devote to our programs. They may not assign as great a priority to our programs or pursue them as diligently
  as we would if we were undertaking such activities ourselves. If these investigators or collaborators fail to devote sufficient
  time and resources to our drug development programs, or if their performance is substandard, the approval of our regulatory submissions
  and our introductions of new drugs will be delayed or prevented.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our potential
  collaborators may also have relationships with other commercial entities, some of which may compete with us. If outside collaborators
  assist our competitors to our detriment, the approval of our regulatory submissions will be delayed and the sales from our products,
  if any are commercialized, will be less than expected.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may not succeed at in-licensing drug candidates or technologies to expand our product pipeline.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We may not
  successfully in-license drug candidates or technologies to expand our product pipeline. The number of such candidates and technologies
  is limited. Competition among large pharmaceutical companies and biopharmaceutical companies for promising drug candidates and
  technologies is intense because such companies generally desire to expand their product pipelines through in-licensing. If we
  fail to carry out such in-licensing and expand our product pipeline, our potential future revenues may suffer.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we fail to obtain or maintain necessary U.S. Food and Drug Administration clearances for our pain therapy products, or if such
  clearances are delayed, we will be unable to commercially distribute and market our products.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our products
  are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. The process
  of seeking regulatory clearance or approval to market a pain therapy product, in particular a controlled substance is expensive
  and time consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed. If we are
  not successful in obtaining timely clearance or approval of our products from the FDA, we may never be able to generate significant
  revenue and may be forced to cease operations. In particular, the FDA permits commercial distribution of a new pain therapy product
  only after the product has received approval of a New Drug Application (&ldquo;NDA&rdquo;) filed with the FDA pursuant to 21 C.F.R.
  &sect; 314, seeking permission to market the product in interstate commerce in the United States. The NDA process is costly, lengthy
  and uncertain. Any NDA application filed by the Company will have to be supported by extensive data, including, but not limited
  to, technical, nonclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA&rsquo;s satisfaction the
  safety and efficacy of the product for its intended use.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Obtaining
  clearances or approvals from the FDA and from the regulatory agencies in other countries could result in unexpected and significant
  costs for us and consume management&rsquo;s time and other resources. The FDA and other agencies could ask us to supplement our
  submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming actions, or they
  could simply deny our applications. In addition, even if we obtain an NDA approval or pre-market approvals in other countries,
  the approval could be revoked or other restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness.
  We cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals,
  our financial condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may
  be limited. Additionally, even if cleared or approved, the Company&rsquo;s products may not be approved for the specific indications
  that are most necessary or desirable for successful commercialization or profitability.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay
  regulatory approval and commercialization.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Before obtaining
  regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and
  expensive nonclinical testing and clinical trials that the product is both safe and effective for use in each target indication.
  Clinical trial results from the study of chronic pain (e.g., osteoarthritis and chronic low back pain) and neuropathic pain (e.g.,
  painful diabetic neuropathy, postherpetic neuralgia and painful HIV-associated neuropathy) are inherently difficult to predict.
  The primary measure of pain is subjective and can be influenced by factors outside of our control, and can vary widely from day
  to day for a particular patient, and from patient to patient and site to site within a clinical study. The results we have obtained
  in completed animal studies or we have observed in published clinical trials conducted by third parties of other dosage forms
  of the same drug (e.g., sublingual, immediate release oral, parenteral) may not be predictive of results from our future clinical
  trials. Additionally, we may suffer significant setbacks in advanced clinical trials, even after promising results in earlier
  studies.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  cannot predict whether regulatory agencies will determine that the data from our clinical trials support marketing approval.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The FDA&rsquo;s
  and other regulatory agencies&rsquo; decision to approve our analgesic product candidates will depend on our ability to demonstrate
  with substantial clinical evidence through well-controlled clinical trials, that the product candidates are effective, as measured
  statistically by comparing the overall improvement in pain in actively-treated patients against improvement in pain in the control
  group (usually a placebo control). However, there is a possibility that our data may fail to show a statistically significant
  difference from the placebo-control or the active control. Alternatively, there is a possibility that our data may be statistically
  significant, but that the actual clinical benefit of the product candidates may not be considered to be clinically significant,
  clinically relevant or clinically meaningful. Consequently, we believe that the FDA may consider additional data, such as a &ldquo;responder&rdquo;
  analysis, secondary efficacy endpoints and even safety when evaluating whether our product can be approved. We believe that the
  FDA views &ldquo;responders&rdquo; as patients who experience at least a 30% reduction in overall pain. We cannot predict whether
  the regulatory agencies will find that our clinical trial results provide compelling &ldquo;responder&rdquo; or other secondary
  endpoint data. Even if we believe that the data from our trials will support marketing approval in the United States or in Europe,
  we cannot predict whether the agencies will agree with our analysis and approve our applications.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may need to focus our future efforts in new therapeutic areas where we have little or no experience.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Although
  our primary strategic interest is in the area of pain management, a number of our products have potential efficacy in other therapeutic
  areas such as addition. If our drug development efforts in pain management fail, or if the competitive landscape or investment
  climate for analgesic dug development is less attractive, we may need to change the company&rsquo;s strategic focus to include
  development of our product candidates or of newly acquired product candidates for therapeutic areas other than pain. We have very
  limited drug development experience in other therapeutic areas and we may be unsuccessful in making this change from a pain management
  company to a company with a focus in areas other than pain or a company with a focus in multiple therapeutic areas including pain.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  product candidates contain controlled substances, the supply of which may be limited by U.S. government policy and the use of
  which may generate public controversy.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The active
  ingredients in our current product candidates, including levorphanol, buprenorphine and d-Methadone are listed by the DEA, as
  &ldquo;Controlled Substances&rdquo; or schedule substances, under the Controlled Substances Act of 1970. The DEA regulates chemical
  compounds as Schedule I, II, III, IV or V substances, with Schedule I substances considered to present the highest risk of substance
  abuse and Schedule V substances the lowest risk. These product candidates are subject to DEA regulations relating to manufacturing,
  storage, distribution and physician prescription procedures. For example, all regular Schedule II drug prescriptions must be signed
  by a physician and may not be refilled.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Some of
  our drug products (e.g., buprenorphine, REL-1041) have a less restrictive controlled substance schedule (i.e., within the Schedule
  III to V range) than Schedule II drugs. According to the DEA, Schedule V drugs have lower abuse potential than Schedule II, III
  and IV drugs, Schedule IV drugs have lower abuse potential than Schedule II and III drugs and Schedule III drugs have lower abuse
  potential than Schedule II. However, despite the foregoing reduced risk of abuse from Schedule III, IV and V drugs, when compared
  to Schedule II drugs, there is no assurance that such reduced risk can be demonstrated in well controlled non-clinical and/or
  clinical studies in models of physical dependence, psychic dependence, addiction or precipitated withdrawal, or in studies of
  addiction or abuse liability in opioid addicts, opioid ex-addicts or recreational drug users. In the event that a reduced risk
  of abuse from Schedule III, IV and V drugs, when compared to Schedule II drugs is demonstrated in well controlled non-clinical
  and/or clinical studies, there is no assurance that the FDA will agree to incorporation of such favorable language in the products
  prescribing information.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our LevoCap
  ER is a Schedule II drug in an abuse resistant, abuse deterrent or tamper resistant dosage form. Although the dosage form is referred
  to as abuse resistant, abuse deterrent or tamper resistant, a determined or persistent abuser can defeat, wholly or partially,
  the tamper resistance within the dosage form. In addition, opioid addicts and recreational opioid users can over time find new
  methods to defeat the tamper resistance mechanism within the dosage form.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Although
  our LevoCap ER is a tamper resistant dosage form, we may elect to not seek specific language in the prescribing information to
  describe this feature in order to reduce the amount of data required for our NDA, the time required to file the NDA and/or the
  probability of a protracted review process. The absence of such language in the prescribing information may reduce the commercial
  value of the product. Even if we do seek specific language in the prescribing information to describe the tamper resistance feature,
  there is no assurance that FDA will agree to any such language.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Products
  containing controlled substances may generate public controversy. Opponents of these products may seek restrictions on marketing
  and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort
  to persuade the medical community to reject these products. Political pressures and adverse publicity could lead to delays in,
  and increased expenses for, and limit or restrict the introduction and marketing of our product candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Failure
  to comply with the Drug Enforcement Administration regulations, or the cost of compliance with these regulations, may adversely
  affect our business.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">A number
  of our products are opioids and subject to extensive regulation by the DEA, due to their status as controlled substances or scheduled
  drugs. Although d-Methadone is substantially devoid of opioid activity, the DEA may elect to designate it as a controlled substance
  falling under a Schedule, up to the Schedule II [C-II]. Any level of DEA scheduling for d-Methadone, particularly Schedule II,
  III or IV, would substantially reduce commercial interest in d-Methadone. Additionally, d-Methadone is produced by separation
  from racemic methadone, a scheduled drug subject to extensive regulation by the DEA.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The manufacture,
  shipment, storage, sale and use of controlled substances are subject to a high degree of regulation, including security, record-keeping
  and reporting obligations enforced by the DEA. For example, all Schedule II drug prescriptions must be signed by a physician,
  physically presented to a pharmacist and may not be refilled. This high degree of regulation can result in significant costs in
  order to comply with the required regulations, which may have an adverse effect on the development and commercialization of our
  product candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The DEA
  limits the availability and production of all scheduled substances, including our product candidates, through a quota system.
  The DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before assigning quotas
  to manufacturers. In future years, we may need greater amounts of controlled substances to sustain our Phase III development program,
  and we will need significantly greater amounts to implement our commercialization plans if the FDA approves our proposed formulations.
  Any delay or refusal by the DEA in establishing the procurement quota or a reduction in our quota for scheduled controlled substances
  or a failure to increase it over time as we anticipate could delay or stop the clinical development or commercial sale of some
  of our products or product candidates. This could have a material adverse effect on our business, results of operations, financial
  condition and prospects.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Some
  of our products for clinical trials are manufactured outside the United States including Schedule II controlled substances.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Drug Enforcement
  Administration regulations require Scheduled II controlled substances to be manufactured in the United States if the products
  are to be marketed in the United States. There is no guarantee that we will secure a commercial supply agreement with a manufacturer
  based in the United States. Switching or adding commercial manufacturing capability can involve substantial cost and require extensive
  management time and focus, as well as additional regulatory filings. In addition, there is a natural transition period when a
  new manufacturing facility commences work. As a result, delays may occur, which can materially impact our ability to meet our
  desired commercial timelines, thereby increasing our costs and reducing our ability to generate revenue.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The facilities
  of any of our future manufacturers of controlled substances must be approved by the FDA after we submit our NDA and before approval.
  We are dependent on the continued adherence of third party manufacturers to GMP manufacturing and acceptable changes to their
  process. If our manufacturers cannot successfully produce material that conforms to our specifications and the FDA's strict regulatory
  requirements, they will not be able to secure FDA approval for their manufacturing facilities. If the FDA does not approve these
  facilities for the commercial manufacture, we will need to find alternative suppliers, which would result in significant delays
  in obtaining FDA approvals. These challenges may have a material adverse impact on our business, results of operations, financial
  condition and prospects.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We manufacture
  some products outside the United States for development and to conduct human clinical studies either in the US or outside the
  US. These products are for development purposes only, and not for commercial manufacturing.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  the supplier of active pharmaceutical ingredient (API) or pharmaceutical excipient fails to provide us sufficient quantities,
  we may not be able to obtain an alternative supply on a timely or acceptable basis.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We currently
  rely on a single source for our supply of levorphanol. There are presently no alternative sources of pharmaceutical grade levorphanol.
  We may also not be able to find alternative suppliers in a timely manner that would provide levorphanol at acceptable quantities
  and prices. Any interruption in the supply of levorphanol would disrupt our ability to manufacture LevoCap ER and could have a
  material adverse effect on our business. Currently this single source supplies the API for research and development purposes only.
  There is no material agreement for commercial supply at this time.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our pharmaceutical
  excipients and other API&rsquo;s are multisource, although not all sources have an active Drug Master File (DMF) with the FDA.
  (A DMF is a submission to the FDA used to provide confidential detailed information about facilities, processes, or articles used
  in the manufacturing, processing, packaging, and storing of drugs to support a drug development and approval). In addition, some
  of the countries for our multisource APIs are not the same as our drug manufacturing locations. Thus, any disruption in supply
  from our preferred vendor could result in significant delays with our pharmaceutical development, clinical trials, NDA filing,
  NDA approval or commercial sale of the finished product due to contract delays, the need to manufacture a new batch of API, out
  of specification API, the need for import and export permits, and the failure of the newly sourced API to perform to the standards
  of the previously sourced API.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  pain product candidates are in the early stages of development and we have not demonstrated that any of our products can actually
  treat pain.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Adverse
  or inconclusive results from pre-clinical testing or clinical trials of product candidates may substantially delay, or halt entirely,
  any further development of one or more of our products. The projected timetables for continued development of the technologies
  and related product candidates by us may otherwise be subject to delay or suspension.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>&nbsp;</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
  <!-- Field: Page; Sequence: 25; Value: 1 -->
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Modifications
  to our products may require new NDA approvals.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Once a particular
  company product receives FDA approval or clearance, expanded uses or uses in new indications of our products may require additional
  human clinical trials and new regulatory approvals or clearances, including additional IND and NDA submissions and premarket approvals
  before we can begin clinical development, and/or prior to marketing and sales. If the FDA requires new clearances or approvals
  for a particular use or indication, we may be required to conduct additional clinical studies, which would require additional
  expenditures and harm our operating results. If the products are already being used for these new indications, we may also be
  subject to significant enforcement actions.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Conducting
  clinical trials and obtaining clearances and approvals can be a time consuming process, and delays in obtaining required future
  clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in
  turn would harm our future growth.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>There
  is no guarantee that the FDA will grant NDA approval of our future products and failure to obtain necessary clearances or approvals
  for our future products would adversely affect our ability to grow our business.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We are currently
  preparing to conduct several Phase I/II clinical trials for our drug candidates and in the future expect to submit NDAs to the
  FDA for approval of these products. The FDA may not approve or clear these products for the indications that are necessary or
  desirable for successful commercialization. Indeed, the FDA may refuse our requests for NDA market approval of new products, new
  intended uses or indications to existing or future products. Failure to receive approval for our new products would have an adverse
  effect on our ability to expand our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have no manufacturing capabilities and depend on other parties for our manufacturing operations. If these manufacturers fail to
  meet our requirements and strict regulatory requirements, our product development and commercialization efforts may be materially
  harmed.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We currently
  depend on contract manufacturers. We plan to enter into long-term commercial supply agreements for our product candidates. If
  any manufacturer is unable to produce required quantities on a timely basis or at all, our operations would be delayed and our
  business harmed. Our reliance on contract manufacturers exposes us to additional risks, including:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">failure of our
      future manufacturers to comply with strictly-enforced regulatory requirements;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">failure to manufacture
      to our specifications, or to deliver sufficient quantities in a timely manner;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the possibility
      that we may terminate a contract manufacturer and need to engage a replacement;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the possibility
      that our future manufacturers may not be able to manufacture our product candidates and products without infringing the intellectual
      property rights of others;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the possibility
      that our future manufacturers may not have adequate intellectual property rights to provide for exclusivity and prevent competition;
      and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">insufficiency
      of intellectual property rights to any improvements in the manufacturing processes or new manufacturing processes for our
      products.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Any of these
  factors could result in significant delay or suspension of our clinical trials, regulatory submissions, receipt of required approvals
  or commercialization of our products and harm our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Delays
  in the commencement or completion of pharmaceutical development, manufacturing or clinical efficacy and safety testing could result
  in increased costs to us and delay our ability to generate revenues.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We do not
  know whether our pharmaceutical development, manufacturing or clinical efficacy and safety testing will begin on time or be completed
  on schedule, if at all. For example, we may encounter delays during the manufacture of pilot scale batches including delays with
  our contract development or manufacturing organization, sourcing satisfactory quantities of active pharmaceutical ingredient,
  narcotic import and export permits, sourcing of excipients, contract disputes with our third party vendors and manufacturers,
  or failure of the product to meet specification. Similar delays may occur a during our GMP manufacture of the product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The commencement
  and completion of clinical trials can be disrupted for a variety of reasons, including difficulties in:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">recruiting and
      enrolling patients to participate in a clinical trial;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">obtaining regulatory
      approval to commence a clinical trial;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">reaching agreement
      on acceptable terms with prospective clinical research organizations and trial sites;</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">manufacturing
      sufficient quantities of a product candidate;</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">investigator fraud,
      including data fabrication by clinical trial personnel;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">diversion of controlled
      substances by clinical trial personnel; and</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">A clinical
  trial may also be suspended or terminated by us, the FDA or other regulatory authorities due to a number of factors, including:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">failure to conduct
      the clinical trial in accordance with regulatory requirements or in accordance with our clinical protocols;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">inspection of
      the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical
      hold;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">unforeseen safety
      issues; or</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">inadequate patient
      enrollment or lack of adequate funding to continue the clinical trial.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes,
  which could impact the cost, timing or successful completion of a clinical trial. If we experience delays in the commencement
  or completion of our clinical trials, the commercial prospects for our product candidates will be harmed, and our ability to generate
  product revenues will be delayed. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
  trials may also lead to the denial of regulatory approval of a product candidate.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  intend to rely on third parties to conduct our clinical trials. If these third parties do not perform as contractually required
  or otherwise expected, we may not be able to obtain regulatory approval for our product candidates.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">At this
  time we do not have any ongoing trials. However, we do not currently intend to conduct clinical trials on our own, and instead
  will rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract
  laboratories, to assist us with our clinical trials. We are also required to comply with regulations and standards, commonly referred
  to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and
  reported results are credible and accurate and that the trial participants are adequately protected. If these third parties do
  not successfully carry out their duties to us or regulatory obligations or meet expected deadlines, if the third parties need
  to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical
  protocols or regulatory requirements or for other reasons, our nonclinical development activities or clinical trials may be extended,
  delayed, suspended or terminated, and we may not be able to obtain regulatory approval for our product candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Clinical
  trials necessary to support NDA approval of our future products will be time consuming and expensive. Delays or failures in our
  clinical trials will prevent us from commercializing our products and will adversely affect our business, operating results and
  prospects and could cause us to cease operations.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Initiating
  and completing clinical trials necessary to support NDA approval of a new formulation of an existing product or a new product,
  will be time consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily
  predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical
  trials.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Some of
  the trials we undertake are not designed to support final NDA approval of the product and additional trials will have to be conducted
  in the future before we file an NDA. In addition, there can be no assurance that the data generated during the trials will meet
  our chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing or approval
  of an NDA.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Conducting
  successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to
  identify and recruit.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patient
  enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size
  of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with,
  the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; and
  proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in
  the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the
  trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness
  of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable
  risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous
  clinical trials of competitive products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Development
  of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop
  such protocols to support clearance and approval.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The FDA
  may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period
  or change the data collection requirements or data analysis applicable to our clinical trials. They may also require additional
  data on certain categories of patients, should it emerge during the conduct of our clinical trials that certain categories of
  patients are likely to be affected in different and/or additional manner than most of the patients. In addition to FDA requirements,
  our clinical trial requires the approval of the institutional review board, or IRB, at each site selected for participation in
  our clinical trial.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Additional
  delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial,
  if such modifications are warranted and/or required by the occurrences in the given trial</I></B><I> .</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Each of
  such modifications has to be submitted to the FDA. This could result in the delay or halt of a clinical trial while the modification
  is evaluated. In addition, depending on the magnitude and nature of the changes made, FDA could take the position that the data
  generated by the clinical trial cannot be pooled because the same protocol was not used throughout the trial. This might require
  the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying clearance
  or approval of a product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>There
  can be no assurance that the data generated using modified protocols will be acceptable to FDA.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">There can
  be no assurance that the data generated using modified protocols will be acceptable to FDA or that if future modifications during
  the trial are necessary, any such modifications will be acceptable to FDA. If FDA believes that its prior approval is required
  for a particular modification, it can delay or halt a clinical trial while it evaluates additional information regarding the change.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Serious
  injury or death resulting from a failure of one of our drug candidates during current or future clinical trials could also result
  in the FDA delaying our clinical trials or denying or delaying clearance or approval of a product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Even though
  an adverse event may not be the result of the failure of our drug candidate, FDA or an IRB could delay or halt a clinical trial
  for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Any delay
  or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining
  or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate
  in a clinical trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during
  the trials, may cause an increase in costs and delays in the filing of any product submissions with the FDA, delay the approval
  and commercialization of our products or result in the failure of the clinical trial, which could adversely affect our business,
  operating results and prospects. Lengthy delays in the completion of clinical trials of our products would adversely affect our
  business and prospects and could cause us to cease operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">On November
  29, 2006 the FDA imposed a bold warning on the label of racemic methadone, a parent compound to our d-Methadone related to cardiac
  death. Although the decision was based on case reports and not on a controlled clinical trial, as part of the development of d-Methadone
  we will likely have to conduct a specific study to evaluate the effects of d-Methadone on QTc interval prolongation. QT interval
  is a measure of the time between the start of the Q wave and the end of the T wave in the heart&rsquo;s electrical cycle. Drugs
  that prolong the corrected QT interval (QTc) interval are associated with an increased risk of serious disturbances in heart rhythm,
  leading to sudden death. QT interval studies can be extremely costly and there is no assurance that we will have funds to undertake
  such a study. In addition, even if we do a QT interval prolongation study in accordance with regulatory guidelines, there is no
  assurance that the results of the study will demonstrate an absence of QT interval prolongation with d-Methadone. An adverse safety
  outcome from such study could result in a similar bolded warning on the label of d-Methadone or in a decision not to approve d-Methadone,
  either one of which could have serious consequences for our continued operation.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform
  as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We do not
  have the ability to independently conduct all the pre-clinical and clinical trials for our products and we must rely on third
  parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct
  such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected
  deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due
  to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development
  activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval
  for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects
  may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical
  trials for reasons outside of their control.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>The
  future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery
  of unexpected adverse side effects.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Even if
  our clinical trials are completed as planned, we cannot be certain that their results will support our drug candidate claims or
  that the FDA or foreign authorities will agree with our conclusions regarding them. Success in pre-clinical studies and early
  clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will
  replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our drug
  candidates are safe and effective for the proposed indicated uses. If FDA concludes that the clinical trials for any of our products
  for which we might seek clearance, have failed to demonstrate safety and effectiveness, we would not receive FDA clearance to
  market that product in the United States for the indications sought. In addition, such an outcome could cause us to abandon the
  product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing
  of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.
  It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part
  of the product candidate&rsquo;s profile. In addition, our clinical trials performed until now involve a relatively small patient
  population. Because of the small sample size, their results may not be indicative of future results.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Future
  products may never achieve market acceptance.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Future products
  that we may develop may never gain market acceptance among physicians, patients and the medical community. The degree of market
  acceptance of any of our products will depend on a number of factors, including the actual and perceived effectiveness and reliability
  of our products; the results of any long&minus;term clinical trials relating to use of our products; the availability, relative
  cost and perceived advantages and disadvantages of alternative technologies; the degree to which treatments using our products
  are approved for reimbursement by public and private insurers; the strength of our marketing and distribution infrastructure;
  and the level of education and awareness among physicians and hospitals concerning our products. Failure of any of our products
  to significantly penetrate current or new markets would negatively impact our business, financial condition and results of operations.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>To
  be commercially successful, physicians must be persuaded that using our products for treatment of pain are effective alternatives
  to existing therapies and treatments.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We believe
  that pain doctors and other physicians will not widely adopt our products unless they determine, based on experience, clinical
  data, and published peer reviewed journal articles, that the use of our products provides an effective alternative to other means
  of treating pain. Patient studies or clinical experience may indicate that treatment with our products does not provide patients
  with sufficient benefits in pain intensity and/or quality of life. We believe that recommendations and support for the use of
  our products from influential physicians will be essential for widespread market acceptance. Our products are still in the development
  stage and it is premature to attempt to gain support from physicians at this time. We can provide no assurance that such support
  will ever be obtained. If our products do not receive such support from these physicians and from long-term data, physicians may
  not use or continue to use, and hospitals may not purchase or continue to purchase, our products.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Even
  if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulation or if
  we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the
  market.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Any product
  for which we obtain clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical data
  and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections
  by the FDA. In particular, we and our suppliers are required to comply with FDA&rsquo;s Quality System Regulations, or QSR, and
  International Standards Organization, or ISO, regulations for the manufacture of our products and other regulations which cover
  the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and
  shipping of any product for which we obtain clearance or approval. Regulatory bodies, such as the FDA, enforce these regulations
  through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered
  by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations
  or product safety issues could result in, among other things, enforcement actions by the FDA.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">If any of
  these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent
  us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance
  with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in
  the required quantities, if at all.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Even if
  regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended
  uses for which the product may be marketed and reduce the potential to successfully commercialize the product and generate revenue
  from the product. If the FDA determines that the product promotional materials, labeling, training or other marketing or educational
  activities constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify
  our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal,
  state or foreign enforcement authorities might take action if they consider such training or other promotional materials to constitute
  promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as
  laws prohibiting false claims for reimbursement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products,
  and we must comply with adverse event and pharmacovigilance reporting requirements, including the reporting of adverse events
  which occur in connection with, and whether or not directly related to, our products. Later discovery of previously unknown problems
  with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing
  problems, or failure to comply with regulatory requirements, may result in changes to labeling, restrictions on such products
  or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to recall,
  replace or refund the cost of any product we manufacture or distribute, fines, suspension of regulatory approvals, product seizures,
  injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and
  prospects.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Some
  of our other product candidates will require Risk Evaluation and Mitigation Strategies (REMS).</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The FDA
  Amendments Act of 2007 implemented safety-related changes to product labeling and requires the adoption of REMS. Some of our product
  candidates, the controlled substance-based and maybe others, will require REMS. The REMS may include requirements for special
  labeling or medication guides for patients, special communication plans to health care professionals and restrictions on distribution
  and use. We cannot predict the specific REMS to be required as part of the FDA's approval of any of our products. Depending on
  the extent of the REMS requirements, our costs to commercialize our products may increase significantly. Furthermore, controlled
  substances risks that are not adequately addressed through proposed REMS for our product candidates may also prevent or delay
  their approval for commercialization.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  revenue stream will depend upon third party reimbursement.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The commercial
  success of our products in both domestic and international markets will be substantially dependent on whether third-party coverage
  and reimbursement is available for patients that use our products. However, the availability of insurance coverage and reimbursement
  for newly approved drugs to treat pain is uncertain, and therefore, third-party coverage may be particularly difficult to obtain
  even if our products are approved by the FDA as safe and efficacious. Many patients using existing approved therapies are generally
  reimbursed all or part of the product cost by Medicare or other third-party payors. Medicare, Medicaid, health maintenance organizations
  and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of
  reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for these products. Submission of
  applications for reimbursement approval generally does not occur prior to the filing of an NDA for that product and may not be
  granted for as long as many months after NDA approval. In order to obtain reimbursement arrangements for these products, we or
  our commercialization partners may have to agree to a net sales price lower than the net sales price we might charge in other
  sales channels. The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare may limit
  our revenue. Initial dependence on the commercial success of our products may make our revenues particularly susceptible to any
  cost containment or reduction efforts.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  are dependent on third parties for manufacturing and marketing of our proposed proprietary products. If we are not able to secure
  favorable arrangements with such third parties, our business and financial condition could be harmed.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We are not
  planning to manufacture any of our proposed proprietary products for commercial sale nor do we have the resources necessary to
  do so. In addition, we currently do not have the capability to market our drug products ourselves. We intend to contract with
  specialized manufacturing companies to manufacture our proposed proprietary products and partner with larger pharmaceutical companies
  for commercialization of our products, retaining the marketing and promotion rights for specialty medical areas. In connection
  with our efforts to commercialize our proposed proprietary products, we will seek to secure favorable arrangements with third
  parties to distribute, promote, market and sell our proposed proprietary products. If we are not able to secure favorable commercial
  terms or arrangements with third parties for distribution, marketing, promotion and sales of our proposed proprietary products,
  we may have to retain promotional and marketing rights and seek to develop the commercial resources necessary to promote or co-promote
  or co-market certain or all of our proprietary drug candidates to the appropriate channels of distribution in order to reach the
  specific medical market that we are targeting. We may not be able to enter into any partnering arrangements on this or any other
  basis. If we are not able to secure favorable partnering arrangements, or are unable to develop the appropriate resources necessary
  for the commercialization of our proposed proprietary products, our business and financial condition could be harmed. In addition,
  we will have to hire additional employees or consultants, since our current employees have limited experience in these areas.
  Sufficient employees with relevant skills may not be available to us. Any increase in the number of our employees would increase
  our expense level, and could have an adverse effect on our financial position.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  we, or our potential commercial partners, may not successfully introduce our proposed proprietary products or our proposed proprietary
  products may not achieve acceptance by patients, health care providers and insurance companies. Further, it is possible that we
  may not be able to secure arrangements to manufacture, market, distribute, promote and sell our proposed proprietary products
  on favorable commercial terms that would permit us to make a profit. To the extent that corporate partners conduct clinical trials,
  we may not be able to control the design and conduct of these clinical trials.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  must enter into an agreement with, and depend upon, one or more partners to assist us in commercializing our product candidates.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Because
  of our limited financial and other resources, we must actively seek and enter into a collaboration with one or more partners to
  assist us in our product launch, if marketing approval is granted. Any collaboration agreement we enter into may contain unfavorable
  terms, for example, with respect to product candidates covered, control over decisions and responsibilities, termination rights,
  payment, and other significant terms. Our ability to receive any significant revenue from our product candidates covered by the
  collaboration agreement will be dependent on the efforts of our collaboration partner and may result in lower levels of income
  to us than if we marketed our product candidates entirely on our own. The collaboration partner may not fulfill its obligations
  or commercialize our product candidates as quickly as we would like. We could also become involved in disputes with our partner,
  which could lead to delays in or termination of our commercialization programs and time-consuming and expensive litigation or
  arbitration. If a collaboration partner terminates or breaches its agreement with us, or otherwise fails to complete its obligations
  in a timely manner, the chances of successfully developing or commercializing our product candidates would be materially and adversely
  affected.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Additionally,
  depending upon the collaboration partner that we choose, other companies that might otherwise be interested in developing products
  with us could be less inclined to do so because of our relationship with the collaboration partner. If our ability to work with
  present or future strategic partners or collaborators is adversely affected as a result of our collaboration agreement, our business
  prospects may be limited and our financial condition may be adversely affected.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We may have
  conflicts with our partners, such as conflicts concerning the interpretation of nonclinical or clinical data, the achievement
  of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership
  of intellectual property developed during our collaboration. If any conflicts arise with any of our partners, such partner may
  act in a manner that is adverse to our best interests. Any such disagreement could result in one or more of the following, each
  of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating
  revenues: unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;
  uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent
  us from entering into additional collaborations; unwillingness by the partner to cooperate in the development or manufacture of
  the product, including providing us with product data or materials; unwillingness on the part of a partner to keep us informed
  regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those
  activities; initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or attempts
  by either party to terminate the agreement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  have no experience selling, marketing or distributing products and no internal capability to do so.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We currently
  have no sales, marketing or distribution capabilities. In order to commercialize our products, if any are approved, we intend
  to develop internal sales, marketing and distribution capabilities to target particular markets for our products, as well as make
  arrangements with third parties to perform these services for us with respect to other markets for our products. We may not be
  able to establish these capabilities internally or hire marketing and sales personnel with appropriate expertise to market and
  sell our products, if approved. In addition, even if we are able to identify one or more acceptable collaborators to perform these
  services for us, we may not be able to enter into any collaborative arrangements on favorable terms, or at all. If we enter into
  any collaborative arrangements for the marketing or sale of our products, our product revenues are likely to be lower than if
  we marketed and sold our products ourselves. In addition, any revenues we receive would depend upon the efforts of our collaborators,
  which may not be adequate due to lack of attention or resource commitments, management turnover, change of strategic focus, business
  combinations, and their inability to comply with regulatory requirements or other factors outside of our control. Depending upon
  the terms of our collaboration, the remedies we have against an under-performing collaborator may be limited. If we were to terminate
  a relationship, it may be difficult or impossible to find a replacement collaborator on acceptable terms, if at all.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Upon
  commercialization of our products, we may be dependent on third parties to market, distribute and sell our products.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our ability
  to receive revenues may be dependent upon the sales and marketing efforts of any future co-marketing partners and third-party
  distributors. At this time, we have not entered into an agreement with any commercialization partner and only plan to do so after
  the successful completion of Phase II clinical trials and prior to commercialization. If we fail to reach an agreement with any
  commercialization partner or upon reaching such an agreement that partner fails to sell a large volume of our products, it may
  have a negative impact on our business, financial condition and results of operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  products will face significant competition in the markets for such products, and if they are unable to compete successfully, our
  business will suffer.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our products
  candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical
  and biotechnology companies as well as academic and research institutions. We compete in an industry that is characterized by:
  (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions.
  Our competitors have existing products and technologies that will compete with our products and technologies and may develop and
  commercialize additional products and technologies that will compete with our products and technologies. Because several competing
  companies and institutions have greater financial resources than us, they may be able to: (i) provide broader services and product
  lines, (ii) make greater investments in research and development, (R&amp;D<B>)</B> , and (iii) carry on larger R&amp;D initiatives.
  Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking
  nonclinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.
  They also have greater name recognition and better access to customers than us. Our chief competitors include companies such as
  Purdue Pharma, Pfizer, Eli Lilly, Endo, Astra Zeneca, among others.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  are faced with intense competition and rapid technological change, which may make it more difficult for us to achieve significant
  market penetration. If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient
  product revenues and our business will suffer.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The market
  for our product candidates is characterized by intense competition and rapid technological advances. If our product candidates
  receive FDA approval, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed
  by others. If our competitors&rsquo; existing products or new products are more effective than or considered superior to our future
  products, the commercial opportunity for our product candidates will be reduced or eliminated. Existing or future competing products
  may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may
  offer comparable performance at a lower cost. We face competition from fully integrated pharmaceutical companies and smaller companies
  that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private
  research organizations. If we are successful in penetrating the market for pain treatment with our product candidates, other companies
  may be attracted to the market. Many of our competitors have analgesics already approved or in development. In addition, many
  of these competitors, either alone or together with their collaborative partners, are larger than we are and have substantially
  greater financial, technical, research, marketing, sales, distribution and other resources than we do. Our competitors may develop
  or market products that are more effective or commercially attractive than any that we are developing or marketing. Our competitors
  may obtain regulatory approvals, and introduce and commercialize products before we do. These developments could have a significant
  negative effect on our financial condition. Even if we are able to compete successfully, we may not be able to do so in a profitable
  manner.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Adverse
  events involving our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could
  harm our reputation, business and financial results.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Once a product
  receives FDA clearance or approval, the agency has the authority to require the recall of commercialized products in the event
  of adverse side effects, material deficiencies or defects in design or manufacture. The authority to require a recall must be
  based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death. Manufacturers
  may, under their own initiative, recall a product if any material deficiency in a product is found. A government-mandated or voluntary
  recall by us or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination,
  manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert
  managerial and financial resources and have an adverse effect on our financial condition and results of operations. The FDA requires
  that certain classifications of recalls be reported to FDA within 10 working days after the recall is initiated. Companies are
  required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls
  involving our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations,
  they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers
  and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they
  were conducted.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may be exposed to liability claims associated with the use of hazardous materials and chemicals.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our research
  and development activities involve the controlled use of hazardous materials and chemicals. Although we believe that our safety
  procedures for using, storing, handling and disposing of these materials comply with federal, state and local laws and regulations,
  we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident,
  we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial
  condition and results of operations. In addition, the federal, state and local laws and regulations governing the use, manufacture,
  storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance
  costs that could materially adversely affect our business and financial condition.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability
  lawsuits.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The testing
  and marketing of medical products entail an inherent risk of product liability. We may be held liable if serious adverse reactions
  from the use of our product candidates occur. If we cannot successfully defend ourselves against product liability claims, we
  may incur substantial liabilities or be required to limit commercialization of our product candidates. Our inability to obtain
  sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent
  or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators. We currently do
  not carry product liability insurance. We, or any corporate collaborators, may not be able to obtain insurance at a reasonable
  cost, if at all. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses,
  such indemnification may not be available or adequate if any claim arises.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  business depends upon securing and protecting critical intellectual property.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our commercial
  success will depend in part on our obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies
  in the United States and other jurisdictions as well as successfully enforcing this intellectual property and defending this intellectual
  property against third-party challenges. We will only be able to protect our technologies from unauthorized use by third parties
  to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them. In particular,
  we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and
  processes. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only
  limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. Moreover,
  the degree of future protection of our proprietary rights is uncertain for products that are currently in the early stages of
  development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial
  versions of these products will incorporate proprietary technologies.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  patent position is highly uncertain and involves complex legal and factual questions.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Accordingly,
  we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. For example,
  we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and
  issued patents; we or our licensors might not have been the first to file patent applications for these inventions; others may
  independently develop similar or alternative technologies or duplicate any of our technologies; it is possible that none of our
  pending patent applications or the pending patent applications of our licensors will result in issued patents; our issued patents
  and issued patents of our licensors may not provide a basis for commercially viable technologies, or may not provide us with any
  competitive advantages, or may be challenged and invalidated by third parties; and, we may not develop additional proprietary
  technologies that are patentable.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">As a result,
  our owned and licensed patents may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret
  protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm
  our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We or our
  licensors have applied for and will continue to apply for patents for certain products. Such applications may not result in the
  issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.
  Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a
  preferred competitive position because of such patents, any preferred position held by us would be lost. If we are unable to secure
  or to continue to maintain a preferred position, we could become subject to competition from the sale of generic products. Failure
  to receive, inability to protect, or expiration of our patents would adversely affect our business and operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patents
  issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing our patent rights against
  infringers, if such enforcement is required, could be significant, and the Company does not currently have the financial resources
  to fund such litigation. Further, such litigation can go on for years and the time demands could interfere with our normal operations.
  There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical
  industry. We may become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved
  in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation more effectively
  than we can because of their substantially greater financial resources. Litigation may also absorb significant management time.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Unpatented
  trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and
  commercial success. Although we attempt to and will continue to attempt to protect our proprietary information through reliance
  on trade secret laws and the use of confidentiality agreements with our corporate partners, collaborators, employees and consultants
  and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any
  event, others may develop independently, or obtain access to, the same or similar information.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Certain
  of our patent rights are licensed to us by third parties. If we fail to comply with the terms of these license agreements, our
  rights to those patents may be terminated, and we will be unable to conduct our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  following is a summary of our patents and patent applications:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><U>Levorphanol</U>:
  </B>These patent applications cover the Levorphanol product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  12/223.327 filed 1/29/07, Abuse Resistant and Extended Release Formulations and Method of Use Thereof. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  12/597,702 filed 4/28/08, Multimodal Abuse Resistant and Extended Release Opioid Formulations. Currently claims are allowed. Issued
  fee paid.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  13/320,9889 filed 2/26/10, Extended Release Oral Pharmaceutical Compositions of 3-Hydroxy-N-Methylmorphinan and Method of Use.
  Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><U>d-Methadone</U>:
  </B>These patent and patent application cover the d-Methadone product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent No.
  6,008,258 filed 1/21/98, d-Methadone, a Nonopioid Analgesic, Patent granted.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  13/803,375 filed 3/14/13, d-Methadone for the Treatment of Psychiatric Symptoms. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><U>Buprenorphine</U>:
  </B>This patent application covers the buprenorphine product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  12/988,209 filed 3/9/09, Oral Pharmaceutical Compositions of Buprenorphine and Method of Use. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"></FONT></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><U>Mepivacaine</U></B>:
  This patent application covers the Mepivacaine product.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Patent application
  PCT/US2011/032,381 filed 4/13/11, Dermal Pharmaceutical Composition of 1-Methyl-2&rsquo;,6&rsquo;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">-Pipecoloxylidide
  and Method of Use. Currently pending.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development
  efforts, obtain a license to continue the development or sale of our products, and/or pay damages.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our manufacturing
  processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities
  or others, or the trade secrets of those persons and entities. As the pharmaceutical industry expands and more patents are issued,
  the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade secrets
  of others. These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing
  and marketing of the affected product or process. If any of these actions are successful, in addition to any potential liability
  for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the
  affected product or use the affected process. Required licenses may not be available on acceptable terms, if at all, and the results
  of litigation are uncertain. If we become involved in litigation or other proceedings, it could consume a substantial portion
  of our financial resources and the efforts of our personnel.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  ability to protect and enforce our patents does not guaranty that we will secure the right to commercialize our patents.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">A patent
  is a limited monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing of
  a new and non-obvious invention. This monopoly is of limited duration but, while in force, allows the patent holder to prevent
  others from making and/or using his invention. While a patent gives the holder this right to exclude others, it is not a license
  to commercialize the invention, where other permissions may be required for permissible commercialization to occur. For example,
  a drug cannot be marketed without the appropriate authorization from the FDA, regardless of the existence of a patent covering
  the product. Further, the invention, even if patented itself, cannot be commercialized if it infringes the valid patent rights
  of another party.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties,
  our trade secrets may become known to our competitors.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We rely
  on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties. If these agreements
  are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. We may not have any
  remedies against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate
  us for the damaging disclosure. In addition, we may have to expend resources to protect our interests from possible infringement
  by others.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">If we are
  unable to obtain the statutory patent extension related to the review time in the United States, we may need to rely on the 3-year
  Hatch-Waxman Act marketing exclusivity, the six month pediatric exclusivity, any approved 7- year Orphan Drug exclusivities, potential
  future formulation patents and up to ten years of data exclusivity in Europe.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may not be able to obtain or maintain orphan drug exclusivity for our products.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The FDA
  Office of Orphan Products (OOPD) has granted orphan drug designation for mepivacaine to which we have secured rights. The orphan
  designations cover postherpetic neuralgia and painful HIV neuropathy. If a product that has orphan drug designation subsequently
  receives FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e.,
  for seven years, the FDA may not approve any other applications to market the same drug for the same indication, except in very
  limited circumstances. We may be unable to obtain orphan drug designations for any additional mepivacaine product candidates or
  orphan exclusivity for any of our product candidates, or our potential competitors may obtain orphan drug exclusivity for mepivacaine-based
  products competitive with our product candidates before we do, in which case we may be excluded from that market for the exclusivity
  period. Even if we obtain orphan drug exclusivity for any of our product candidates, we may not be able to maintain it if a competitive
  product is shown to be clinically superior to our product. Although obtaining FDA approval to market a product with orphan exclusivity
  can be advantageous, there can be no assurance that it would provide us with a significant commercial advantage.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other
  jurisdictions for our products.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We intend
  to rely, in part, on Hatch-Waxman exclusivity for the commercialization of our products in the United States. The Hatch-Waxman
  Act provides marketing exclusivity to the first applicant to gain approval of an NDA under specific provisions of the Food, Drug
  and Cosmetic Act for a product using an active ingredient that the FDA has not previously approved (five years) or for a new dosage
  form, route or indication (three years). This market exclusivity will not prevent the FDA from approving a competitor&rsquo;s
  NDA if the competitor&rsquo;s NDA is based on studies it has performed and not on our studies.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">There can
  be no assurance that European authorities will grant data exclusivity for our products, because it does not contain a new active
  molecule. Even if European data exclusivity is granted for our products, that may not protect us from direct competition. Given
  the well-established use of our product candidates as pain relievers, a competitor with a generic version of our products may
  be able to obtain approval of their product during our product&rsquo;s period of data exclusivity, by submitting a marketing authorization
  application (MAA) with a less than full package of nonclinical and clinical data.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
  <!-- Field: Page; Sequence: 34; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may undertake international operations, which will subject us to risks inherent with operations outside of the United States.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Although
  we do not have any foreign operations at this time, we intend to seek to obtain market clearances in foreign markets that we deem
  to generate significant opportunities. However, even with the cooperating of a commercialization partner, conducting drug development
  in foreign countries involves inherent risks, including, but not limited to: difficulties in staffing, funding and managing foreign
  operations; unexpected changes in regulatory requirements; export restrictions; tariffs and other trade barriers; difficulties
  in protecting, acquiring, enforcing and litigating intellectual property rights; fluctuations in currency exchange rates; and
  potentially adverse tax consequences.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">If we were
  to experience any of the difficulties listed above, or any other difficulties, any international development activities and our
  overall financial condition may suffer and cause us to reduce or discontinue our international development and registration efforts.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may not be successful in hiring and retaining key employees.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our future
  operations and successes depend in large part upon the continued service of key members of our senior management team whom we
  are highly dependent upon to manage our business, specifically Dr. Traversa, our CEO.&nbsp;If he terminates his employment with
  us, such a departure would have a material adverse effect on our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our future
  success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial,
  technical, clinical and regulatory personnel. We will need to hire additional qualified personnel with expertise in nonclinical
  pharmacology and toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing.
  We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions.
  Competition for such individuals, particularly in the United States, is intense, and we may not be able to hire sufficient personnel
  to support our efforts. There can be no assurance that these professionals will be available in the market, or that we will be
  able to retain existing professionals or to meet or to continue to meet their compensation requirements. Furthermore, the cost
  base in relation to such compensation, which may include equity compensation, may increase significantly, which could have a material
  adverse effect on us. Failure to establish and maintain an effective management team and work force could adversely affect our
  ability to operate, grow and manage our business.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">comply with FDA
      regulations or similar regulations of comparable foreign regulatory authorities; provide accurate information to the FDA or
      comparable foreign regulatory authorities;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">comply with federal
      and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable
      foreign regulatory authorities;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">report financial
      information or data accurately; or</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">disclose unauthorized
      activities to us.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In particular,
  sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to
  prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide
  range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
  Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could
  result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Ethics, but it is not always possible
  to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective
  in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits
  stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and
  we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business
  and results of operations, including the imposition of significant fines or other sanctions.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
  <!-- Field: Page; Sequence: 35; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  relationships with customers and payors will be subject to applicable anti-kickback, fraud and abuse, transparency, and other
  healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational
  harm, administrative burdens, and diminished profits and future earnings.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Healthcare
  providers, physicians and payors play a primary role in the recommendation and prescription of any product candidates for which
  we may obtain marketing approval. Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse
  and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through
  which we market, sell and distribute any product candidates for which we may obtain marketing approval. Restrictions under applicable
  federal, state and foreign healthcare laws and regulations may affect our ability to operate, including:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the federal Anti-Kickback
      Statute, which prohibits, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration,
      directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase,
      order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs
      such as Medicare and Medicaid;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the federal False
      Claims Act, which imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against
      individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment
      that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal
      government;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">state and foreign
      anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items
      or services reimbursed by non-governmental payors, including private insurers;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">the federal Health
      Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a
      scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">HIPAA, as amended
      by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, which
      also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well
      as their business associates that perform certain services involving the use or disclosure of individually identifiable health
      information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
      individually identifiable health information;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">laws which require
      pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance
      guidance promulgated by the federal government or otherwise restricting payments that may be made to healthcare providers;
      and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">federal laws requiring
      drug manufacturers to report information related to payments and other transfers of value made to physicians and other healthcare
      providers, as well as ownership or investment interests held by physicians and their immediate family members, including under
      the federal Open Payments program, as well as other state and foreign laws regulating marketing activities.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Managing
  our growth as we expand operations may strain our resources.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We expect
  to need to grow rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our
  drug candidates, which will place a significant strain on our financial, managerial and operational resources. In order to achieve
  and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities. Moreover,
  we will need to increase staffing and to train, motivate and manage our employees. All of these activities will increase our expenses
  and may require us to raise additional capital sooner than expected. Failure to manage growth effectively could harm our business,
  financial condition or results of operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may not successfully manage our growth.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our success
  will depend upon the expansion of our operations and the effective management of our growth. We expect to experience significant
  growth in the scope of our operations and the number of our employees. If we grow significantly, such growth will place a significant
  strain on our management and on our administrative, operational and financial resources. To manage this growth, we must expand
  our facilities, augment our operational, financial and management systems, internal controls and infrastructure and hire and train
  additional qualified personnel. Our future success is heavily dependent upon growth and acceptance of our future products. If
  we are unable to scale our business appropriately or otherwise adapt to anticipated growth and new product introduction, our business
  and financial condition will be harmed.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  may expand our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial
  condition and may also dilute current stockholders&rsquo; ownership interests in our company.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our business
  strategy includes expanding our products and capabilities, and we may seek acquisitions of drug candidates or technologies to
  do so. Acquisitions involve numerous risks, including substantial cash expenditures; potentially dilutive issuance of equity securities;
  incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;
  difficulties in assimilating the acquired technologies or the operations of the acquired companies; diverting our management&rsquo;s
  attention away from other business concerns; risks of entering markets in which we have limited or no direct experience; and the
  potential loss of our key employees or key employees of the acquired companies.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
  <!-- Field: Page; Sequence: 36; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We cannot
  assure you that any acquisition will result in short-term or long-term benefits to us. We may incorrectly judge the value or worth
  of an acquired product, company or business. In addition, our future success would depend in part on our ability to manage the
  rapid growth associated with some of these acquisitions. We cannot assure you that we will be able to make the combination of
  our business with that of acquired products, businesses or companies work or be successful. Furthermore, the development or expansion
  of our business or any acquired products, business or companies may require a substantial capital investment by us. We may not
  have these necessary funds or they might not be available to us on acceptable terms or at all. We may also seek to raise funds
  by selling shares of our preferred or common stock, which could dilute each current stockholder&rsquo;s ownership interest in
  the Company.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  are unable to develop our own sales, marketing and distribution capabilities, or if we are not successful in contracting with
  third parties for these services on favorable terms, or at all, our product revenues could be disappointing</I></B><I> .</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We currently
  have no sales, marketing or distribution capabilities. In order to commercialize our products, if any are approved by the FDA,
  we will either have to develop such capabilities internally or collaborate with third parties who can perform these services for
  us. If we decide to commercialize any of our drugs ourselves, we may not be able to hire the necessary experienced personnel and
  build sales, marketing and distribution operations which are capable of successfully launching new drugs and generating sufficient
  product revenues. In addition, establishing such operations will take time and involve significant expense.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">If we decide
  to enter into new co-promotion or other licensing arrangements with third parties, we may be unable to locate acceptable collaborators
  because the number of potential collaborators is limited and because of competition from others for similar alliances with potential
  collaborators. Even if we are able to identify one or more acceptable new collaborators, we may not be able to enter into any
  collaborative arrangements on favorable terms, or at all.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  any revenues we receive would depend upon our collaborators&rsquo; efforts which may not be adequate due to lack of attention
  or resource commitments, management turnover, change of strategic focus, business combinations or other factors outside of our
  control. Depending upon the terms of our collaboration, the remedies we have against an under-performing collaborator may be limited.
  If we were to terminate the relationship, it may be difficult or impossible to find a replacement collaborator on acceptable terms,
  or at all.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and
  our business will suffer.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The market
  for our drug candidates is characterized by intense competition and rapid technological advances. If our drug candidates receive
  FDA approval, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed
  by others. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for
  a specific indication than our products, or may offer comparable performance at a lower cost. If our products are unable to capture
  and maintain market share, we may not achieve sufficient product revenues and our business will suffer.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We and our
  collaborators will compete for market share against fully integrated pharmaceutical companies or other companies that are collaborating
  with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations.
  Many of these competitors have drugs already approved or drug candidates in development that will or may compete against our approved
  drug candidates. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger
  research and development programs and have substantially greater financial resources than we do, as well as significantly greater
  experience in:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">developing drugs;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">conducting preclinical
      testing and human clinical trials;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">obtaining FDA
      and other regulatory approvals of drugs;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">formulating and
      manufacturing drugs; and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">launching, marketing,
      distributing and selling drugs.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"></P>
  
  <!-- Field: Page; Sequence: 37; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Government
  agencies, professional and medical societies, and other groups may establish usage guidelines that apply to our</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Law enforcement
  concerns over diversion of opioids and social issues around abuse of opioids may make the regulatory approval process and commercialization
  of our drug candidates very difficult.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Media stories
  regarding the diversion of opioids and other controlled substances are commonplace. Law enforcement agencies or regulatory agencies
  may apply policies that seek to limit the availability of opioids. Such efforts may adversely affect the regulatory approval and
  commercialization of our drug candidates.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Developments
  by competitors may render our products or technologies obsolete or non-competitive.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Alternative
  technologies and products are being developed to improve or replace the use of opioids for pain management, several of which are
  in clinical trials or are awaiting approval from the FDA. In addition, the active ingredients in nearly all opioid drugs are available
  in generic form. Drug companies that sell generic opioid drugs represent substantial competition. Many of these organizations
  competing with us have substantially greater capital resources, larger research and development staffs and facilities, greater
  experience in drug development and in obtaining regulatory approvals and greater manufacturing and marketing capabilities than
  we do. Our competitors may market less expensive or more effective drugs that would compete with our drug candidates or reach
  market with competing drugs before we are able to reach market with our drug candidates. These organizations also compete with
  us to attract qualified personnel and partners for acquisitions, joint ventures or other collaborations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Business
  interruptions could limit our ability to operate our business.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our operations
  as well as those of our collaborators on which we depend are vulnerable to damage or interruption from computer viruses, human
  error, natural disasters, electrical and telecommunication failures, international acts of terror and similar events. We have
  not established a formal disaster recovery plan and our back-up operations and our business interruption insurance may not be
  adequate to compensate us for losses we may suffer. A significant business interruption could result in losses or damages incurred
  by us and require us to cease or curtail our operations.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Unfavorable
  media coverage of opioid pharmaceuticals could negatively affect our business.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Opioid drug
  abuse receives a high degree of media coverage. Unfavorable publicity regarding, for example, the use or misuse of oxycodone or
  other opioid drugs, the limitations of abuse-resistant formulations, public inquiries and investigations into prescription drug
  abuse, litigation or regulatory activity, or the independent actions regarding the sales, marketing, distribution or storage of
  our drug products, could adversely affect our reputation. Such negative publicity could have an adverse effect on the potential
  size of the market for our drug candidates and decrease revenues and royalties, which would adversely affect our business and
  financial results.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Risks
  Related to Ownership of Our Common Stock</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>There
  is a limited market for our common stock which may make it more difficult to dispose of your stock.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>&nbsp;</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our
  common stock is currently quoted on the OTCQB under the symbol &ldquo;RLMD&rdquo;. There is a limited trading market for our
  common stock. Accordingly, there can be no assurance as to the liquidity of any markets that may develop for our common stock,
  the ability of holders of our common stock to sell shares of our common stock, or the prices at which holders may be able to sell
  their common stock.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>A
  sale of a substantial number of shares of our common stock may cause the price of the common stock to decline.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">If our stockholders
  sell substantial amounts of our common stock in the public market, the market price of our common stock could fall. These sales
  also may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem
  reasonable or appropriate. Stockholders who have been issued shares in the Reverse Merger will be able to sell their shares pursuant
  to Rule 144 under the Securities Act of 1933, beginning one year after the stockholders acquired their shares, subject to limitations
  imposed by the lock-up agreements.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>We
  are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other
  projects, thus impairing our ability grow.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We are a
  public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other
  federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002 (the &ldquo;Sarbanes-Oxley Act&rdquo;). The
  costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing
  audited reports to stockholders would cause our expenses to be higher than they would be if we remained privately held and did
  not consummate the Reverse Merger. In addition, we will incur substantial expenses in connection with the preparation of the registration
  statement and related documents required under the terms of our May and June 2014 offerings.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">It may be
  time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by
  the Sarbanes-Oxley Act. We may need to hire additional financial reporting, internal controls and other finance personnel in order
  to develop and implement appropriate internal controls and reporting procedures. If we are unable to comply with the internal
  controls requirements of the Sarbanes-Oxley Act, then we may not be able to obtain the independent accountant certifications required
  by such act, which may preclude us from keeping our filings with the SEC current.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>If
  we fail to establish and maintain an effective system of internal control, we may not be able to report our financial results
  accurately or to prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation
  and adversely impact the trading price of our Common Stock.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Effective
  internal control is necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial
  reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment
  existed, and our business and reputation with investors may be harmed. As a result, our small size and any current internal control
  deficiencies may adversely affect our financial condition, results of operation and access to capital. We have not performed an
  in-depth analysis to determine if historical un-discovered failures of internal controls exist, and may in the future discover
  areas of our internal control that need improvement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>The
  issuing of our press release, dated July 1, 2014, which was not in compliance with Rule 134 of the Securities Act of 1933, as
  amended (the &ldquo;Securities Act&rdquo;) and potentially Section 5(b) of the Securities Act, could subject us to rescission
  rights by investors that are participating in the offering</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">On July
  1, 2014, we filed a press release announcing the filing of registration statement on Form S-1, of which this prospectus is a part.
  The press release was not in compliance with the provisions of Rule 134 of the Securities Act. The SEC has regulations concerning
  the ability of an issuer to make public announcements during a registered public offering of its securities. Rule 134 of the Securities
  Act is a safe harbor which permits an issuer to make a public announcement during the waiting period (the period after filing
  the registration statement). As a result, investors in this offering may potentially be entitled to bring suit against the Company
  for not being in compliance with the Securities Act, and such investor may be able to obtain rescission rights. The potential
  costs, risks and liabilities associated with such potential lawsuits, rights of rescission and/or regulatory actions cannot be
  accurately assessed at this time, but in the event such lawsuits, rescission offerings and/or regulatory actions are instituted,
  our Company believes that such actions will not have a material financial effect on our Company.&nbsp; Also, our Company&rsquo;s
  inability to resolve any potential violation of Section 5 of the Securities Act to the satisfaction of the SEC could result in
  a delay or prohibition in obtaining the effectiveness of any future registration statements, which could hinder or impair the
  ability to obtain future financing.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Public
  company compliance may make it more difficult to attract and retain officers and directors.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The Sarbanes-Oxley
  Act and new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.
  As a public company, we expect these new rules and regulations to increase our compliance costs in 2012 and beyond and to make
  certain activities more time consuming and costly. As a public company, we also expect that these new rules and regulations may
  make it more difficult and expensive for us to obtain director and officer liability insurance in the future and we may be required
  to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a
  result, it may be more difficult for us to attract and retain qualified persons to serve on our board of directors or as executive
  officers.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  stock price may be volatile.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The market
  price of our Common Stock is likely to be highly volatile and could fluctuate widely in price in response to various factors,
  many of which are beyond our control, including the following:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 24px; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">changes in our
      industry;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">competitive pricing
      pressures;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">our ability to
      obtain working capital financing;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">additions or departures
      of key personnel;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">limited &ldquo;public
      float&rdquo; in the hands of a small number of persons whose sales or lack of sales could result in positive or negative pricing
      pressure on the market price for our common stock;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">sales of our common
      stock;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">our ability to
      execute our business plan;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">operating results
      that fall below expectations;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">loss of any strategic
      relationship;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">regulatory developments;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">economic and other
      external factors;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">period-to-period
      fluctuations in our financial results; and</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">inability to develop
      or acquire new or needed technology or products.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0"></P>
  
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  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In addition,
  the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the
  operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price
  of our Common Stock.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>Our
  Common Stock may be deemed a &ldquo;penny stock,&rdquo; which would make it more difficult for our investors to sell their shares.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our common
  stock may be subject to the &ldquo;penny stock&rdquo; rules adopted under Section 15(g) of the Exchange Act.&nbsp;The penny stock
  rules generally apply to companies whose common stock is not listed on The Nasdaq Stock Market or other national securities exchange
  and trades at less than $5.00 per share, other than companies that have had average revenue of at least $6,000,000 for the last
  three years or that have tangible net worth of at least $5,000,000 ($2,000,000 if the company has been operating for three or
  more years). These rules require, among other things, that brokers who trade penny stock to persons other than &ldquo;established
  customers&rdquo; complete certain documentation, make suitability inquiries of investors and provide investors with certain information
  concerning trading in the security, including a risk disclosure document and quote information under certain circumstances. Many
  brokers have decided not to trade penny stocks because of the requirements of the penny stock rules and, as a result, the number
  of broker-dealers willing to act as market makers in such securities is limited. If we remain subject to the penny stock rules
  for any significant period, it could have an adverse effect on the market, if any, for our securities. If our securities are subject
  to the penny stock rules, investors will find it more difficult to dispose of our securities.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B><I>You
  may have difficulty trading and obtaining quotations for our Common Stock.</I></B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Our securities
  are actively traded, and the bid and asked prices for our Common Stock on the Over-the-Counter Bulletin Board may fluctuate
  widely. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our securities.&nbsp;This
  severely limits the liquidity of the Common Stock, and would likely reduce the market price of our Common Stock and hamper our
  ability to raise additional capital.&nbsp;There is a limited market for our securities. Accordingly, investors may therefore bear
  the economic risk of an investment in the Securities thereof, for an indefinite period of time. Even if an active market develops
  for the common stock, Rule 144 promulgated under the Securities Act (&quot;Rule 144&quot;), which provides for an exemption from
  the registration requirements under the Securities Act under certain conditions, requires, among other conditions, a one-year
  holding period prior to the resale (in limited amounts) of securities acquired in a non-public offering without having to satisfy
  the registration requirements under the Securities Act. There can be no assurance that we will fulfill any reporting requirements
  in the future under the Securities Exchange Act of 1934, as amended, or disseminate to the public any current financial or other
  information concerning the Company, as is required by Rule 144 as part of the conditions of its availability. Our securities have
  not been registered under the Securities Act.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-indent: 0.5in; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_005"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>USE
  OF PROCEEDS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  shares which may be sold pursuant to this prospectus will be sold for the respective accounts of each of the selling stockholders.
  Accordingly, the Company will not realize any proceeds from the sale of the shares, except that it will derive proceeds if options
  currently outstanding or hereafter granted are exercised. If exercised, such funds will be available to the Company for working
  capital and general corporate purposes. No assurance can be given, however, as to when or if any or all of the options will be
  exercised. All expenses of the registration of the shares have been paid for by the Company. See &ldquo;Selling Stockholders&rdquo;
  and &ldquo;Plan of Distribution.&rdquo;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></P>
  
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_006"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>SELLING
  STOCKHOLDERS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">The
  847,147 shares of our common stock to which this reoffer prospectus relates is comprised entirely of shares issuable upon the
  exercise of options granted under the Plan to the selling stockholders named below, and are being registered for reoffers and
  resales by such selling stockholders, who acquired the shares pursuant to one of our &ldquo;employee benefit plans&rdquo; as that
  term is defined in Rule 405 of Regulation C under the Securities Act. The shares of common stock that may be resold pursuant to
  this prospectus may be subject the satisfaction of certain applicable vesting conditions pursuant to the terms of the respective
  grants. Such selling stockholders may resell all, a portion, or none of the shares of common stock from time to time while this
  prospectus is effective. Any changed information will be set forth in an amendment to the registration statement or supplement
  to this reoffer prospectus, to the extent required by law.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">The
  following table sets forth the name and relationship to the Company of the selling stockholders and information regarding beneficial
  ownership of our common stock by the selling stockholders as of October 1, 2015. Unless otherwise indicated, beneficial ownership
  is determined in accordance with the rules of the Commission, and is based upon information provided by each respective selling
  stockholder identified below and other public documents filed with the Commission.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Unless
  otherwise specified, the address of each of the selling stockholders listed below is c/o Relmada Therapeutics, Inc., 757
  Third Avenue, Suite 2018, New York, NY 10017.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"></FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" STYLE="border-collapse: collapse; width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: bottom">
      <TD STYLE="text-align: left; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Selling Stockholder</B></FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD STYLE="text-align: center; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>Position</B> </FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Total&nbsp;Shares</B> <B><BR>
  Beneficially</B> <BR>
  <B>Owned Prior</B> <BR>
  <B>to Offering&nbsp;(1)</B></FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>Maximum</B> <B><BR>
  Shares<BR>
  </B> <B>Offered<BR>
  </B> <B>Pursuant<BR>
  </B> <B>to this<BR>
  </B> <B>Prospectus</B> </FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>Shares<BR>
  </B> <B>Beneficially <BR>
  Owned<BR>
  </B> <B>Following<BR>
  </B> <B>Resale (2)</B> </FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD>
      <TD COLSPAN="2" STYLE="text-align: center; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>Percentage<BR>
  </B> <B>of<BR>
  </B> <B>Outstanding<BR>
  </B> <B>Shares of<BR>
  </B> <B>Common Stock<BR>
  </B> <B>after the<BR>
  </B> <B>Offering (3)</B> </FONT></TD><TD STYLE="text-align: center; padding-bottom: 1.5pt">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="width: 29%; text-align: left">Charles Casamento</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 22%">Director</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">25,765</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">25,765</TD><TD STYLE="width: 1%; text-align: left">(4)</TD><TD STYLE="width: 1%">&nbsp;</TD>
      <TD STYLE="width: 1%; text-align: left">&nbsp;</TD><TD STYLE="width: 9%; text-align: right">&nbsp;</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"></TD><TD STYLE="width: 1%; text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Christopher James</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">30,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">30,000</TD><TD STYLE="text-align: left">(5)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Christine Silverstein</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">50,400</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">50,400</TD><TD STYLE="text-align: left">(6)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Danny Kao</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">46,380</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">42,500</TD><TD STYLE="text-align: left">(7)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">3,880</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Donna Cummings</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">1,700</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">1,700</TD><TD STYLE="text-align: left">(8)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Douglas Beck</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Chief Financial Officer</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">71,840</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">71,840</TD><TD STYLE="text-align: left">(9)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Elizabeth Nolan</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">80,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">80,000</TD><TD STYLE="text-align: left">(10)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">&nbsp;</TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Fai Jim</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">24,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">24,000</TD><TD STYLE="text-align: left">(11)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Kulendiran Purushothaman</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">40,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">40,000</TD><TD STYLE="text-align: left">(12)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Michael Becker</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">82,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">82,000</TD><TD STYLE="text-align: left">(13)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Nabil Yazgi</TD><TD>&nbsp;</TD>
      <TD>Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">49,733</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">9,733</TD><TD STYLE="text-align: left">(14)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">40,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Richard Mangano</TD><TD>&nbsp;</TD>
      <TD>Employee</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">56,000</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">56,000</TD><TD STYLE="text-align: left">(15)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Sandesh Seth</TD><TD>&nbsp;</TD>
      <TD>Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">9,733</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">9,733</TD><TD STYLE="text-align: left">(16)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: White">
      <TD STYLE="text-align: left">Sergio Traversa</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">Chief Executive Officer</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">413,284</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">313,743</TD><TD STYLE="text-align: left">(17)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">99,541</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;* </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: bottom; background-color: rgb(204,238,255)">
      <TD STYLE="text-align: left">Sheeram Agharkar</TD><TD>&nbsp;</TD>
      <TD>Director</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">9,733</TD><TD STYLE="text-align: left">&nbsp;</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">9,733</TD><TD STYLE="text-align: left">(18)</TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right">-</TD><TD STYLE="text-align: left"></TD><TD>&nbsp;</TD>
      <TD STYLE="text-align: left">&nbsp;</TD><TD STYLE="text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">*
  </FONT></TD><TD STYLE="text-align: left">&nbsp;</TD></TR>
  </TABLE>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 4%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(1)</FONT></TD>
      <TD STYLE="width: 96%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
      securities &ldquo;beneficially owned&rdquo; by a person are determined in accordance with the definition of
      &ldquo;beneficial     ownership&rdquo; set forth in the rules and regulations promulgated under the Exchange Act, and
      accordingly, may include securities     owned by and for, among others, the spouse and/or minor children of an individual and
      any other relative who has the same     home as such individual, as well as other securities as to which the individual has
      or shares voting or investment power or     which such person has the right to acquire within 60 days of October 1, 2015
      pursuant to the exercise of options, or otherwise.     &nbsp;Beneficial ownership may be disclaimed as to certain of the
      securities.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(2)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Assumes
      that all shares of common stock offered by this prospectus are sold in this offering and that no other transactions with respect
      to shares of our common stock occur.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(3)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">Based on 11,014,155 shares of common stock and
      71,672 shares of Class A preferred stock issued and outstanding as of October 1, 2015.</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(4)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      25,765 shares of common stock underlying outstanding options granted to the selling stockholder .</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(5)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      (i) 16,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 14,000 shares
      of restricted common stock granted to the selling stockholder.</FONT></TD></TR>
  </TABLE>
  
  <P STYLE="margin: 0">&nbsp;</P>
  
  <P STYLE="margin: 0"></P>
  
  <!-- Field: Page; Sequence: 41; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->34<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="margin: 0">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 4%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(6)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 96%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      (i) 40,400 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 10,000 shares
      of restricted common stock granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(7)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(8)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(9)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(10)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;Includes
      (i) 50,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 30,000 shares
      of restricted common stock granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(11)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(12)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      (i) 20,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 20,000 shares
      of restricted common stock granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(13)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      (i) 62,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 20,000 shares
      of restricted common stock granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(14)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(15)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(16)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes all shares of common stock underlying outstanding options granted to the selling stockholder</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(17)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(18)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">*</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Less
      than 1% of our common stock.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 42; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->35<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_007"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>PLAN
  OF DISTRIBUTION</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">The
  common shares being offered for resale by the selling stockholders consist of 847,147 shares of common stock underlying
  outstanding options and restricted common stock granted to the selling stockholders under the Plans. We will pay any fees and
  expenses incurred by us incident to the registration of the securities.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Each
  selling stockholder of the securities and any of their pledgees, assignees and successors-in-interest permitted under the Plan
  may, from time to time, sell any or all of their securities covered hereby on OTCQB or any other stock exchange, market or trading
  facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A selling
  stockholder may use any one or more of the following methods when selling securities:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">ordinary
      brokerage transactions and transactions in which the broker-dealer solicits purchasers;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&nbsp;</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&nbsp;</TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">block
      trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the
      block as principal to facilitate the transaction;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">purchases
      by a broker-dealer as principal and resale by the broker-dealer for its account;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">an
      exchange distribution in accordance with the rules of the applicable exchange;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">privately
      negotiated transactions;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">settlement
      of short sales entered into after the effective date of the registration statement of which this prospectus is a part;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">in
      transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities
      at a stipulated price per security;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">through
      the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">a
      combination of any such methods of sale; or</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&#9679;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">any
      other method permitted pursuant to applicable law.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  selling stockholders may also sell securities under Rule 144 under the Securities Act, if available, rather than under this prospectus.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: left; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  amount of our common stock to be reoffered or resold by means of this prospectus by each selling stockholder, and any other person
  with whom such selling stockholder is acting in concert for the purpose of selling securities of our company, may not exceed,
  during any three month period, the amount specified in Rule 144(e) of the Securities Act.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: left; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Broker-dealers
  engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive
  commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities,
  from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an
  agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a
  principal transaction a markup or markdown in compliance with FINRA IM-2440.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: left; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">In
  connection with the sale of the securities or interests therein, the selling stockholders may enter into hedging transactions
  with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of
  hedging the positions they assume. The selling stockholders may also sell securities short and deliver these securities to close
  out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The selling
  stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one
  or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered
  by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus
  (as supplemented or amended to reflect such transaction).</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: left; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  selling stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be &ldquo;underwriters&rdquo;
  within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
  or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
  under the Securities Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding,
  directly or indirectly, with any person to distribute the securities.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: left; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities
  laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or
  qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and
  is complied with.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Under
  applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not
  simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined
  in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable
  provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of
  purchases and sales of securities of the common stock by the selling stockholders or any other person. We will make copies of
  this prospectus available to the selling stockholders and have informed them of the need to deliver a copy of this prospectus
  to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 43; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->36<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_008"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>LEGAL
  MATTERS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  validity of the shares of common stock being offered pursuant to this prospectus will be passed upon by Fennemore Craig, P.C.,
  Reno, NV.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_009"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>EXPERTS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  audited financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been
  so incorporated by reference in reliance upon the report of GBH CPAs, PC an independent registered public accounting firm, upon
  the authority of said firm as experts in accounting and auditing in giving said report.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_010"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>WHERE
  YOU CAN FIND MORE INFORMATION</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  filed with the Commission a registration statement under the Securities Act for the common stock in this offering. This prospectus
  does not contain all of the information in the registration statement and the exhibits and schedule that were filed with the registration
  statement. For further information with respect to us and our common stock, we refer you to the registration statement and the
  exhibits that were filed with the registration statement. Statements contained in this prospectus about the contents of any contract
  or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and we refer you
  to the full text of the contract or other document filed as an exhibit to the registration statement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  file annual, quarterly, and current reports and other information with the Commission. Our filings with the the Commission are
  available to the public on the commission&rsquo;s website at www.sec.gov. Those filings are also available to the public on our
  corporate website at www.relmada.com. The information we file with the Commission or contained on, or linked to through, our corporate
  website or any other website that we may maintain is not part of this prospectus or the registration statement of which this prospectus
  is a part. You may also read and copy, at the Commission&rsquo;s prescribed rates, any document we file with the Commission, including
  the registration statement (and its exhibits) of which this prospectus is a part, at the Commission&rsquo;s Public Reference Room
  located at 100 F Street, N.E., Washington, D.C. 20549. You can call the Commission at 1-800-SEC-0330 to obtain information on
  the operation of the Public Reference Room.&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_011"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>INCORPORATION
  OF CERTAIN DOCUMENTS BY REFERENCE</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  are incorporating by reference certain information that we have filed with the Commission under the informational requirements
  of the Exchange Act, which means that we are disclosing it to you by referring to another document filed separately with the Commission.
  The information contained in the documents we are incorporating by reference is considered to be a part of this prospectus, and
  the information that we later file with the Commission will automatically update and supersede the information contained or incorporated
  by reference in this prospectus. Accordingly, we incorporate by reference:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">Our Form 10-K for the year ended June 30, 2015,
  filed with the Securities and Exchange Commission on September 11, 2015; and</TD></TR>
  
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
      description of our common stock, which is contained in our Form 8-K, filed with the Securities and Exchange Commission on
      May 27, 2014.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  <!-- Field: Page; Sequence: 44; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">All
  documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of this
  prospectus and prior to the filing of a post-effective amendment indicating that all securities offered have been sold or which
  deregisters all securities then remaining unsold, are incorporated by reference in this prospectus and are a part of this prospectus
  from the respective dates of filings of such documents. Any statement contained herein or in a document incorporated or deemed
  to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus to the extent
  that a statement contained herein or in any other filed document which also is or is deemed to be incorporated by reference herein
  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.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">You
  may request a copy of any filings or information incorporated herein by reference, at no cost, by writing or telephoning us at
  the following address and telephone number: Relmada Therapeutics, Inc., 757 3rd Avenue, Suite 2018, New York, NY 10017, Attention:
  Sergio Traversa, telephone number (212) 376-5776.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><A NAME="a_012"></A><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>DISCLOSURE
  OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes,
  or NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.138 of the NRS provides that, unless the corporation&rsquo;s Articles of Incorporation provide otherwise, a director or officer
  will not be individually liable unless it is proven that (i) the director&rsquo;s or officer&rsquo;s acts or omissions constituted
  a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of
  the law. Our Articles of Incorporation provide that no director or officer shall be personally liable to the corporation or any
  of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability of a director or
  officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii) payment of dividends
  in violation of Section 78-300 of the NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid
  in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding,
  if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or
  director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding,
  had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes
  indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion
  of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent
  that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for
  such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or
  otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending
  a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination
  by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation
  to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount
  if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified
  by the company if so provided in the corporations articles of incorporation, by-laws, or other agreement. Section 78.751 of the
  NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of
  incorporation, by-laws, or other agreement.&nbsp; </FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf
  of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the
  company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise,
  for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee,
  or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him or her against such
  liability and expenses.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  By-laws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter
  acquire under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person&rsquo;s
  official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased
  to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such
  person.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  maintain a general liability insurance policy that covers liabilities of directors and officers of our corporation arising out
  of claims based on acts or omissions in their capacities as directors or officers.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>No
  one has been authorized 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, such information or representations must not be relied upon as having been authorized
  by us. This prospectus does not constitute an offer or a solicitation by anyone in any jurisdiction in which such offer or solicitation
  is not authorized or in which the person making such offer is not qualified to do so or to anyone to whom it is unlawful to make
  such offer or solicitation. Neither the delivery of this prospectus nor any sale hereunder shall, under any circumstances, create
  any implication that there has not been any change in our affairs since the date hereof.</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></P>
  
  <!-- Field: Page; Sequence: 45; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%"><!-- Field: Sequence; Type: Arabic; Name: PageNo -->38<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>PART
  II</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>INFORMATION
  REQUIRED IN THE REGISTRATION STATEMENT</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item
      3.</B></FONT></TD>
      <TD STYLE="text-align: justify"><B>Incorporation of Documents by Reference.</B></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  are subject to the informational requirements of the Securities Exchange Act of 1934, as amended (the &ldquo;Exchange Act&rdquo;)
  and, in accordance therewith, file reports and other information with the Commission. The following documents, or portions thereof,
  filed by us with the Commission pursuant to the Exchange Act, are incorporated by reference in this Registration Statement:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 0.25in; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify">Our Form 10-K as of June 30, 2015 and 2014 and for
      the     year     ended     June     30,     2015, for the six months ended June 30, 2014, and for the year ended December
      31, 2013, filed with     the     Securities     and     Exchange     Commission     on     September     11,     2015;
      and</TD></TR>
  
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; width: 0.25in">&nbsp;</TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">&nbsp;</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&#9679;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
      description of our common stock, which is contained in our Form 8-K, filed with the Securities and Exchange Commission on
      May 27, 2014.</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">All
  documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of this
  Registration Statement and prior to the filing of a post-effective amendment to this Registration Statement indicating that all
  securities offered have been sold or which deregisters all securities then remaining unsold, are incorporated by reference in
  this Registration Statement and are a part of this Registration Statement from the respective dates of filings of such documents.
  Any statement contained herein or in a document incorporated or deemed to be incorporated by reference herein shall be deemed
  to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein or in
  any other filed document which also is or is deemed to be incorporated by reference herein 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 Registration Statement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item
      4.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Description of Securities.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Not
  applicable.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B></B></FONT></P>
  
  <!-- Field: Page; Sequence: 46; Options: NewSection; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">II-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->1<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item&nbsp;5.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Interests of Named Experts and Counsel.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Not
  applicable.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;<B>&nbsp;</B></FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item&nbsp;6.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Indemnification of Directors and Officers.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes,
  or NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.138 of the NRS provides that, unless the corporation&rsquo;s Articles of Incorporation provide otherwise, a director or officer
  will not be individually liable unless it is proven that (i) the director&rsquo;s or officer&rsquo;s acts or omissions constituted
  a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of
  the law. Our Articles of Incorporation provide that no director or officer shall be personally liable to the corporation or any
  of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability of a director or
  officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii) payment of dividends
  in violation of Section 78-300 of the NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid
  in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding,
  if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or
  director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding,
  had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes
  indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion
  of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent
  that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for
  such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or
  otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending
  a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination
  by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation
  to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount
  if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified
  by the company if so provided in the corporations articles of incorporation, bylaws, or other agreement. Section 78.751 of the
  NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of
  incorporation, bylaws, or other agreement.&nbsp; </FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Section
  78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf
  of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the
  company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise,
  for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee,
  or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability
  and expenses.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  Bylaws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter
  acquire under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person&rsquo;s
  official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased
  to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such
  person.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">We
  maintain a general liability insurance policy that covers liabilities of directors and officers of our corporation arising out
  of claims based on acts or omissions in their capacities as directors or officers.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item&nbsp;7.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Exemption From Registration Claimed.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Not
  applicable.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  <!-- Field: Page; Sequence: 47; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item&nbsp;8.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Exhibits.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 12%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Exhibit
  No.</FONT></P></TD>
      <TD STYLE="width: 1%; text-align: justify; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 87%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif"><P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;Description</FONT></P></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Specimen
      Common Stock Certificate*</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Articles
      of Incorporation (incorporated by reference to Exhibit 3.1 to Registration Statement on Form S-1 filed with the SEC on November
      13, 2012).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.3</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Certificate
      of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Report on Form 8-K filed with the SEC on May
      19, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.4</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective May 30, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on May 27, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.5</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective July 8, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on July 14, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.6</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective February 12, 2015 (incorporated by reference to Exhibit 3.1
      to Form 10-Q filed with the SEC on February 13, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.7</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Change Pursuant to NRS 78,209, effective August 11, 2015 (incorporated by reference to Exhibit 3.1 to Form
      8-K filed with the SEC on August 10, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.8</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Bylaws
      of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 of the Company&rsquo;s Form 8-K filed with the SEC
      on May 27, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">5.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Opinion
      of Fennemore Craig, P.C. *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">10.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Relmada
      Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.14 to Form S-1/A filed
      with the SEC on December 9, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">10.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">First
      Amendment to Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit
      10.1 to Form 8-K filed with the SEC on August 7, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">23.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Consent
      of GBH CPAs, PC *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">23.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Consent
      of Fennemore Craig, P.C.&nbsp;&nbsp;(included in Exhibit 5.1) *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">24.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Power
      of Attorney (included on signature page) *</FONT></TD></TR>
  </TABLE>
  
  <P STYLE="margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">*
  Filed herewith&nbsp;</FONT></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  <!-- Field: Page; Sequence: 48; Value: 1 -->
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      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"></P>
  
  <TABLE CELLPADDING="0" CELLSPACING="0" BORDER="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top">
      <TD STYLE="text-align: justify; width: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Item&nbsp;9.</B></FONT></TD>
      <TD STYLE="text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Undertakings.</B></FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  undersigned Company hereby undertakes:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(1)
  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;To file, during any period in which offers or sales are being made, a post-effective
  amendment to this Registration Statement:</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(i)
  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;To include any prospectus required by Section 10(a)(3) of the Securities Act;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(ii)
  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;To reflect in the prospectus any facts or events arising after the effective date
  of the Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent
  a fundamental change in the information set forth in the Registration Statement. Notwithstanding the foregoing, any increase or
  decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered)
  and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus
  filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than
  a 20 percent change in the maximum aggregate offering price set forth in the &ldquo;Calculation of Registration Fee&rdquo; table
  in the effective Registration Statement;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 0.5in; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(iii)
  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>&nbsp;</I></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><I>Provided</I>,
  <I>however</I>, that paragraphs (1)(i) and (1)(ii) above do not apply if the information required to be included in a post-effective
  amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Company pursuant to Section
  13 or Section 15(d) of the Securities Exchange Act that are incorporated by reference in the Registration Statement.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(2)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;That, for the purpose of determining any liability under the Securities
  Act, 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<I> bona fide</I> offering thereof.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(3)
  &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  undersigned Company hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of
  the Company&rsquo;s annual report pursuant to Section&nbsp;13(a) or Section 15(d) of the Exchange Act (and, where applicable,
  each filing of an employee benefit plan&rsquo;s annual report pursuant to Section&nbsp;15(d) of the Exchange Act) 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<I> bona fide</I> offering thereof.</FONT></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">The
  undersigned Company hereby undertakes to deliver or cause to be delivered with the prospectus, to each person to whom the prospectus
  is sent or given, the latest annual report, to security holders that is incorporated by reference in the prospectus and furnished
  pursuant to and meeting the requirements of Rule 14a&ndash;3 or Rule 14c&ndash;3 under the Exchange Act; and, where interim financial
  information required to be presented by Article 3 of Regulation S-X is not set forth in the prospectus, to deliver, or cause to
  be delivered to each person to whom the prospectus is sent or given, the latest quarterly report that is specifically incorporated
  by reference in the prospectus to provide such interim financial information.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Insofar
  as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons
  of the Company pursuant to the foregoing provisions, or otherwise, the Company has been advised that in the opinion of the 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 Company of expenses incurred or paid
  by a director, officer or controlling person of the Company 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 Company 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.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"></FONT></P>
  
  <!-- Field: Page; Sequence: 49; Value: 1 -->
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      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>SIGNATURES</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify">Pursuant
  to the requirements of the Securities Act of 1933, the Company 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, in the City of New York, State of New York, on this 2nd day of October, 2015.</P>
  
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD COLSPAN="2" STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Relmada
      Therapeutics, Inc.</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 60%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 5%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 35%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">By:</FONT></TD>
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Sergio Traversa</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Name:</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Sergio
      Traversa</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Title:</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Chief Executive
      Officer</FONT>
          <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: left"></P></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(Duly Authorized
      Officer and Principal Executive Officer)</FONT></TD></TR>
  
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
      <TD STYLE="line-height: 115%; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="line-height: 115%; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">By:</FONT></TD>
      <TD STYLE="line-height: 115%; border-bottom: Black 1.5pt solid"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">/s/
      Douglas Beck</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">Name:</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">Douglas Beck</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">Title:</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">Chief Financial Officer</FONT></TD></TR>
  <TR STYLE="vertical-align: top">
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="line-height: 115%"><FONT STYLE="font: 10pt/115% Times New Roman, Times, Serif">(Duly Authorized Officer and Principal
      Financial and Accounting Officer)</FONT></TD></TR>
  </TABLE>
  
  
  <P STYLE="margin: 0"></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&nbsp;</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-bottom: 0; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>POWER
  OF ATTORNEY</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; margin-right: 0; margin-bottom: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Each
  person whose signature appears below hereby appoints each of Sandesh Seth and Sergio Traversa, severally, acting alone and without
  the other, his or her true and lawful attorney-in-fact, with full power of substitution, and with the authority to execute in
  the name of each such person, any and all amendments (including without limitation, post-effective amendments) to this registration
  statement, to sign any and all additional registration statements relating to the same offering of securities as this registration
  statement that are filed pursuant to Rule 462(b) of the Securities Act of 1933, and to file such registration statements with
  the Securities and Exchange Commission, together with any exhibits thereto and other documents therewith, necessary or advisable
  to enable the registrant to comply with the Securities Act of 1933, and any rules, regulations and requirements of the Securities
  and Exchange Commission in respect thereof, which amendments may make such other changes in the registration statement as the
  aforesaid attorney-in-fact executing the same deems appropriate.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">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.</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 29%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Signature</B></FONT></TD>
      <TD STYLE="width: 1%; text-align: center; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 50%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Title</B></FONT></TD>
      <TD STYLE="width: 1%; text-align: center; font: 10pt Times New Roman, Times, Serif; padding-bottom: 1.5pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 19%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Date</B></FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: bottom; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Sergio Traversa</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Chief
      Executive Officer and Director</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Sergio
      Traversa</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(principal
      executive officer)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Douglas Beck</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Chief
      Financial Officer</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Douglas
      Beck</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">(Principal
      Financial and Accounting Officer)</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Sandesh Seth</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Chairman
      of the Board</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Sandesh
      Seth</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Shreeram Agharkar</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Director</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Shreeran
      Agharkar</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Nabil Yazgi</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Director</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nabil
      Yazgi</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 29%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">/s/
      Charles Casamento</FONT></TD>
      <TD STYLE="width: 1%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 50%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Director</FONT></TD>
      <TD STYLE="width: 1%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 19%; text-align: justify; font: 10pt Times New Roman, Times, Serif">October 2, 2015</TD></TR>
  <TR STYLE="font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Charles
      Casamento</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="vertical-align: top; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD></TR>
  </TABLE>
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"></P>
  
  <!-- Field: Page; Sequence: 50; Value: 1 -->
      <DIV STYLE="margin-top: 12pt; margin-bottom: 6pt; border-bottom: Black 1.5pt solid"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: center; width: 100%">II-<!-- Field: Sequence; Type: Arabic; Name: PageNo -->5<!-- Field: /Sequence --></TD></TR></TABLE></DIV>
      <DIV STYLE="page-break-before: always; margin-top: 6pt; margin-bottom: 12pt"><TABLE CELLPADDING="0" CELLSPACING="0" STYLE="width: 100%; font: 10pt Times New Roman, Times, Serif"><TR><TD STYLE="text-align: left; width: 100%"><A HREF="#toc">Table of Contents</A></TD></TR></TABLE></DIV>
      <!-- Field: /Page -->
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>INDEX
  TO EXHIBITS</B></FONT></P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify">&nbsp;</P>
  
  <TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; border-collapse: collapse; font: 10pt Times New Roman, Times, Serif">
  <TR STYLE="vertical-align: top; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="width: 12%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Exhibit
      No.</FONT></TD>
      <TD STYLE="width: 1%; text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="width: 87%; border-bottom: Black 1.5pt solid; font: 10pt Times New Roman, Times, Serif; text-align: justify"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Description</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Specimen
      Common Stock Certificate*</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Articles
      of Incorporation (incorporated by reference to Exhibit 3.1 to Registration Statement on Form S-1 filed with the SEC on November
      13, 2012).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.3</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Certificate
      of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Report on Form 8-K filed with the SEC on May
      19, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.4</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective May 30, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on May 27, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.5</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective July 8, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on July 14, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.6</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Amendment to Articles of Incorporation, effective February 12, 2015 (incorporated by reference to Exhibit 3.1
      to Form 10-Q filed with the SEC on February 13, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.7</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Nevada
      Certificate of Change Pursuant to NRS 78,209, effective August 11, 2015 (incorporated by reference to Exhibit 3.1 to Form
      8-K filed with the SEC on August 10, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">4.8</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Bylaws
      of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 of the Company&rsquo;s Form 8-K filed with the SEC
      on May 27, 2014).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">5.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Opinion
      of Fennemore Craig, P.C. *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">10.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Relmada
      Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.14 to Form S-1/A filed
      with the SEC on December 9, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">10.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">First
      Amendment to Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit
      10.1 to Form 8-K filed with the SEC on August 7, 2015).</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">23.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Consent
      of GBH CPAs, PC *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: rgb(204,238,255); font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">23.2</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Consent
      of Fennemore Craig, P.C. &nbsp;(included in Exhibit 5.1) *</FONT></TD></TR>
  <TR STYLE="vertical-align: top; background-color: White; font: 10pt Times New Roman, Times, Serif">
      <TD STYLE="font: 10pt Times New Roman, Times, Serif; text-align: left"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">24.1</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">&nbsp;</FONT></TD>
      <TD STYLE="text-align: justify; font: 10pt Times New Roman, Times, Serif"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">Power
      of Attorney (included on signature page) *</FONT></TD></TR>
  </TABLE>
  
  <P STYLE="margin: 0">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif">*
  Filed herewith&nbsp;</FONT></P>
  
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">&nbsp;</P>
  
  <P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0; border-bottom: Black 1.5pt solid; margin-bottom: 0; text-align: center">E-1</P>
  
  
  
  
  
  </BODY>
  </HTML>
metadata_documents: [{"type": "S-8", "sequence": "1", "filename": "fs82015_relmadatherape.htm", "description": "REGISTRATION STATEMENTS", "secsgml_size_bytes": 599800}]
metadata_filer: {"company-data": {"conformed-name": "RELMADA THERAPEUTICS, INC.", "cik": "0001553643", "assigned-sic": "2834", "irs-number": "455401931", "state-of-incorporation": "NV", "fiscal-year-end": "0630"}, "filing-values": {"form-type": "S-8", "act": "33", "file-number": "333-207253", "film-number": "151140829"}, "business-address": {"street1": "546 FIFTH AVENUE, 14TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10036", "phone": "212-702-7163"}, "mail-address": {"street1": "546 FIFTH AVENUE, 14TH FLOOR", "city": "NEW YORK", "state": "NY", "zip": "10036"}, "former-company": {"former-conformed-name": "CAMP NINE, INC.", "date-changed": "20120706"}}
text: As filed with the Securities and Exchange
  Commission on October 2, 2015
  Registration No. 333-______
  UNITED STATES
  SECURITIES AND EXCHANGE COMMISSION
  WASHINGTON, DC 20549
  FORM S-8
  REGISTRATION STATEMENT
  UNDER
  THE SECURITIES ACT OF 1933
  RELMADA
  THERAPEUTICS, INC.
  (Exact Name of Registrant as Specified in Its
  Charter)
  Nevada
  45-5401931
  (State or other Jurisdiction of
  (I.R.S Employer
  Incorporation or Organization)
  Identification Number)
  757 Third Avenue, Suite 2018, New York, New York
  10017
  (Address of Principal Executive Offices)
  (Zip Code)
  RELMADA THERAPEUTICS,
  INC.
  2014 STOCK OPTION AND EQUITY INCENTIVE STOCK
  PLAN, AS AMENDED
  (Full Title of the Plan)
  Sergio Traversa
  Chief Executive Officer
  757 Third Avenue, Suite 2018
  New York, New York 10017
  Phone: (212) 376-5776
  Fax: (888) 228-5672
  (Name, Address and
  Telephone Number of Agent for Service)
  Copy to:
  Thomas Slusarczyk, Esq.
  Barclay Damon, LLP
  300 South State Street
  Syracuse, New York 13202
  (315) 235-2299
  Indicate by check mark
  whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.
  See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company"
  in Rule 12b-2 of the Exchange Act. (Check one):
  Large
      accelerated filer
  ☐
  Accelerated
  filer
  ☒
  Non-accelerated
      filer
  ☐
  Smaller
  reporting company
  ☐
  (Do not check if a smaller reporting company)
  CALCULATION OF REGISTRATION FEE
  Title of
  securities to
  be registered
  Amount to be registered (1)
  Proposed maximum offering price per share (2)
  Proposed maximum aggregate offering price (2)
  Amount of registration fee
  Common Stock $0.001 par value (3)
  1,611,769
  $
  4.98
  $
  8,026,615
  $
  808.28
  Total
  1,611,769
  $
  4.98
  $
  8,026,615
  $
  808.28
  (1)   This
  Registration Statement also covers additional shares of Relmada Therapeutics, Inc. common stock that may be issuable by reason
  of stock splits, stock dividends, or other adjustment provisions of the Relmada Therapeutics, 2014 Stock Option and Equity Incentive
  Plan, as amended, in accordance with Rule 416 under the Securities Act of 1933, as amended.
  (2)   Estimated
  solely for the purpose of calculating the registration fee computed pursuant to Rule 457(c) and (h), upon the basis of the average
  of the high and low prices of the common stock as quoted on OTCQB on September 29, 2015.
  (3)   Represents
  the number of shares of Common Stock issuable upon the exercise of (a) currently outstanding stock options granted
  pursuant to the Relmada Therapeutics 2014 Stock Option and Equity Incentive Plan, as amended, and (b) stock options and other awards
  that are expected to be granted pursuant to the Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan,
  as amended.
  EXPLANATORY
  NOTE
  This
  Form S-8 relates to (i) the offer and resale of up to an aggregate of 847,147 shares of common stock, par value $0.001 per share
  (the "Common Stock"), of Relmada Therapeutics, Inc., a Nevada corporation (the "Company"), consisting
  of restricted shares of the Company's Common Stock previously issued under the Relmada Therapeutics, Inc. 2014 Stock Option
  and Equity Incentive Plan, as amended (the "Plan) as well as shares of the Company's Common Stock underlying outstanding
  options previously granted under the Plan, (ii) options that may be granted under the Plan to purchase up to an aggregate of 764,622
  shares of the Company's Common Stock, and (iii) up to an aggregate of 764,622 shares of Common Stock of the Company, which
  may underlie options to be granted under the Plan, or which may be stock or other awards which are subject to future grants under
  the Plan.  This Registration Statement contains two parts. First, the materials that follow Part I up to Part II of
  this Registration Statement constitute the reoffer prospectus, prepared in accordance with Part I of Form S-3, in accordance with
  General Instruction C of Form S-8, covering resales of "restricted securities" or "control securities"
  (as defined in General Instruction C of Form S-8). Such resale prospectus relates to shares of the Common Stock of the Company,
  and together with its subsidiaries, ("we", "our" and "us") previously issued to certain of
  our employees pursuant to the Plan. The amount of shares to be reoffered or resold by means of the reoffer prospectus contained
  herein by each selling stockholder, and any other person with whom such selling stockholder is acting in concert for the purpose
  of selling securities of the Company, may not exceed, during any three-month period, the amount specified in Rule 144(e) of the
  Securities Act of 1933, as amended (the "Securities Act"). The second part contains information required to be set
  forth in the registration statement pursuant to Part II of Form S-8.
  PART
  I
  INFORMATION
  REQUIRED IN THE SECTION 10(a) PROSPECTUS*
  Item 1.
  Plan Information.*
  Item 2.
  Registrant Information
      and Employee Plan Annual Information.**
  *
  The documents containing
      the information specified in Part I of Form S-8 will be sent or given to plan participant as specified in Rule 428(b)(1) of
      the Securities Act. Such documents need not be filed with the Securities and Exchange Commission (the "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 Registration Statement, taken together, constitute a prospectus that meets the requirements of Section 10(a) of
      the Securities Act.
  **
  Upon written or oral
      request, any document incorporated by reference in Item 3 of Part II of this Registration Statement (which documents are incorporated
      by reference in this Section 10(a) prospectus), and any document required to be delivered to a participant in the Plans pursuant
      to Rule 428(b) or additional information about the Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan
      is available, without charge, by contacting the Company at:
  Relmada Therapeutics,
      Inc.
  757
  Third Avenue, Suite 2018
  New York, New York 10017
  Attention: Sergio Traversa,
      Tel: (212) 376-5741
  Reoffer Prospectus
  RELMADA
      THERAPEUTICS, INC.
  847,147 Shares of Common
  Stock
  This reoffer prospectus relates
  to the offer and resale of up to an aggregate of 847,147 shares of common stock, par value $0.001 per share, of Relmada Therapeutics,
  Inc. a Nevada corporation, underlying outstanding options previously granted under the Relmada Therapeutics, Inc. 2014 Stock Option
  and Equity Incentive Plan, as amended. The shares of common stock subject to this prospectus may be offered and sold from time
  to time by the selling stockholders listed in this prospectus after the filing of the related registration statement on Form S-8.
  This prospectus has been prepared for the purpose of registering future sales of the shares of common stock by the selling stockholders,
  on a continuous or delayed basis, to the public without restriction. Upon the effectiveness of the related registration statement,
  the selling stockholders may offer these shares for resale for his/her own account from time to time.
  The
  selling stockholders may sell the shares of common stock covered by this prospectus through various means, including directly
  or indirectly to purchasers, in one or more transactions on any stock market on which such shares are traded at the time of sale,
  in privately negotiated transactions, or through a combination of these methods. The selling stockholders selling any shares pursuant
  to this prospectus may be deemed to be an "underwriter" within the meaning of the Securities Act of 1933, as amended.
  Any commissions received by a broker or dealer in connection with resales of shares may be deemed to be underwriting commissions
  or discounts under the Securities Act. For additional information on the selling stockholders' possible methods of sale,
  you should refer to the section in this prospectus entitled "Plan of Distribution."
  We
  will not receive any proceeds from the sale of the shares of common stock being offered by the selling stockholders. We will pay
  all of the expenses associated with this prospectus. Brokerage commissions and similar selling expenses, if any, attributable
  to the offer or sale of the shares of common stock covered by this prospectus will be borne by the respective selling stockholders.
  Our common stock is quoted
  on OTCQB under the symbol "RLMD." On September 29, 2015, the closing price of our common stock on such market was
  $4.35 per share.
  An
  investment in our securities is highly speculative, involves a high degree of risk and should be considered only by persons
  who can afford the loss of their entire investment. Please see "Risk Factors" beginning on page
  12
  of this
  prospectus.
  Neither
  the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
  determined whether this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
  The date of this Prospectus
  is October 2, 2015.
  Table of Contents
  TABLE
  OF CONTENTS
  ABOUT THIS PROSPECTUS
  i
  FORWARD-LOOKING STATEMENTS
  i
  PROSPECTUS SUMMARY
  1
  RISK FACTORS
  12
  USE OF PROCEEDS
  33
  SELLING STOCKHOLDERS
  34
  PLAN OF DISTRIBUTION
  36
  LEGAL MATTERS
  3
  7
  EXPERTS
  3
  7
  WHERE YOU CAN FIND MORE INFORMATION
  3
  7
  INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
  37
  DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
  38
  Table of Contents
  ABOUT
  THIS PROSPECTUS
  You
  should rely only on the information contained in or incorporated by reference into this prospectus. We have not authorized any
  other person to provide you with additional information or information different from that contained in or incorporated by reference
  into this prospectus. The selling stockholders may, from time to time, offer to sell shares of our common stock only in jurisdictions
  where the offer or sale is permitted. You should not assume that the information contained in this prospectus is accurate as of
  any date other than the date on the front cover of this prospectus or that the information contained in any document incorporated
  by reference into this prospectus is accurate as of any date other than the date of the document incorporated by reference.
  FORWARD-LOOKING
  STATEMENTS
  This
  prospectus and other documents we file with the Commission contain forward-looking statements, such as statements concerning our
  expected results of operations, financial resources or our projected plans for the expansion of our business, as well as other
  estimates relating to future operations. Words or phrases of expectation or uncertainty like "expect," "believe,"
  "continue," "anticipate," "estimate," "may," "will," "could,"
  "opportunity," "future," "project," "can," "intend," "plan,"
  "potential," "predict", the negative of these terms or variations of such words and similar expressions
  are intended to identify "forward-looking statements," although not all forward-looking statements contain these identifying
  words. Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot
  guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors,
  including the risks outlined under "Risk Factors" or elsewhere in this prospectus, which may cause our or our industry's
  actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover,
  we operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for
  us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor,
  or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
  All forward-looking statements included in this document are based on information available to us on the date hereof, and we assumes
  no obligation to update any such forward-looking statements.
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  PROSPECTUS
  SUMMARY
  The
  following summary contains basic information about Relmada Therapeutics, Inc. and this prospectus. It may not contain all of the
  information that is important to you. For a more complete understanding, we encourage you to read the entire prospectus and the
  documents incorporated by reference into this prospectus. In this prospectus, the words "Company," "we,"
  "our" and "us" refer to Relmada Therapeutics, Inc. and our subsidiary.
  The
  Securities and Exchange Commission allows us to "incorporate by reference" certain information that we file with it,
  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 this information. Any statement contained in this prospectus or 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 which 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 the notes
  to those statements appearing elsewhere in this prospectus or incorporated herein by reference.
  Company
  Overview
  Relmada
  Therapeutics, Inc. ("Relmada" or the "Company") is a clinical stage biopharmaceutical company focused
  on developing a pipeline of drug candidates to treat chronic pain. Chronic pain is often defined as any pain lasting more
  than 12 weeks. Whereas acute pain is a normal sensation that alerts us to possible injury, chronic pain persists – often
  for months or even longer. Chronic pain may arise from an initial injury, such as back sprain, or there may be an ongoing cause,
  such as an illness. Sometimes there is no clear cause. According to the National Institutes of Health, approximately 100 million
  people in the U.S. are living with chronic pain.
  We
  intend to realize our business objectives by implementing two core strategies to address unmet medical needs in the treatment
  of chronic pain: a) developing improved versions of proven drug candidates; and b) developing new chemical entities. This two
  tiered approach is expected to reduce overall clinical development investment, time, and risks. Our drug candidates are designed
  to improve the overall benefits and use of a drug for patients by improving the metabolism, distribution, pharmacokinetics, pharmacodynamics,
  half-life and/or bioavailability of drugs.
  d-Methadone
  (dextromethadone, REL-1017)
  Our
  most-advanced new chemical entity, d-Methadone (dextromethadone, REL-1017), is a novel, N-methyl-D-aspartate (NMDA) receptor antagonist
  being developed for the treatment of neuropathic pain. As a single isomer of racemic methadone, d-Methadone has been shown to
  possess NMDA antagonist properties with virtually no opioid activity at the expected therapeutic doses. The activation of NMDA
  receptors has been associated with neuropathic pain and it is expected that d-Methadone will have a role in pain management by
  blocking this activity. In contrast, racemic methadone is a long-acting narcotic producing typical opioid side effects used in
  the treatment of various pain states and as a substitution therapy in opioid addiction. In November 2014, Health Canada approved
  a Clinical Trial Application ("CTA") to conduct the first Phase I study with d-Methadone. This is a Single Ascending
  Dose ("SAD") study that will be followed by a Multiple Ascending Dose ("MAD") study, both in healthy volunteers.
  The two studies are designed to assess the safety, tolerability and pharmacokinetics of d-Methadone in healthy subjects. The SAD
  study includes single escalating oral doses of d-Methadone to determine the maximum tolerated dose. In the MAD study, healthy
  subjects are to receive daily oral doses of d-Methadone for several days to assess its safety, pharmacokinetics and tolerability.
  In March 2015, d-Methadone demonstrated a safe profile with no dose limiting side effects after four cohorts were exposed to increasing
  higher doses. In April 2015, the Company received clearance from Health Canada to continue with dose escalation and explore higher
  doses of d-Methadone. In June 2015, the Company successfully completed the SAD study and subsequently received a No Objection
  Letter (NOL) from Health Canada to conduct the MAD clinical study in August 2015. The data from these studies will inform the
  design of a subsequent Phase II proof of concept study.
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  Ketamine
  hydrochloride (ketamine), an NMDA receptor antagonist, is an U.S. Food and Drug Administration ("FDA") FDA-approved,
  rapid-acting general anesthetic that also produces strong analgesia in neuropathic pain states. The NMDA receptor is an excitatory
  glutamatergic receptor present at spinal and supraspinal sites and involved in the afferent transmission of nociceptive signals.
  In chronic pain states prolonged nociceptive stimulation causes activation and upregulation of the NMDA receptor at dorsal horn
  synapses resulting in enhanced and amplified trafficking of pain signals to the brain (central sensitization). This phenomenon
  is an important factor in the process of perseverance of pain. There is now ample evidence that NMDA receptor antagonists that
  block the NMDA receptor, such as ketamine, are able to halt the excessive barrage of nociceptive input to the brain and are therefore
  potential alternatives to existing treatments of chronic pain syndromes. The potential for widespread therapeutic use of ketamine
  is severely limited by its potential for abuse, dissociative and psychosis-like side effects. Orally-available d-Methadone is
  among the new generation of pain medications with potential to deliver ketamine-like palliative effects, without ketamine's
  side effects.
  LevoCap
  ER (REL-1015)
  Our
  most-advanced novel version of a proven drug product, LevoCap ER (REL-1015), is an extended release, abuse deterrent, proprietary
  formulation of the opioid analgesic levorphanol, which is pharmacologically differentiated from morphine, oxycodone, and other
  strong opioids for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. In particular,
  levorphanol binds to all three opioid receptor subtypes involved in analgesia (mu, kappa, and delta), the N-methyl-D-aspartate
  (NMDA) receptor and the norepinephrine and serotonin uptake pumps, whereas morphine is relatively selective for mu sites. The
  dual mechanism of action of levorphanol, combining opioid receptor agonism with noradrenaline reuptake inhibition in the same
  molecule makes levorphanol a useful analgesic to treat chronic and neuropathic pain in addition to providing pain relief in patients
  resistant to other strong opioids. Levorphanol is a strong opioid first synthesized decades ago and is considered equal in potency
  to hydromorphone, oxycodone, fentanyl, and methadone. In clinical studies, it has demonstrated a remarkably broad spectrum of
  analgesic activity against many different types of pain including neuropathic pain, post-surgical pain, and chronic pain in patients
  refractory to other opioids. We continue to scale up manufacturing and prepare for Phase III development program and are planning
  to submit a request to the FDA to discuss the final regulatory and clinical plan for this product. In preparation for pivotal
  trial(s) that we plan to perform under US IND, we are selecting the final formulation and are planning to generate the necessary
  GMP batches.
  BuTab
  (REL-1028)
  Our
  second-most-advanced novel version of a proven drug product, BuTab (REL-1028), represents novel formulations of oral, modified
  release buprenorphine being developed for both chronic pain and opioid dependence indications. Buprenorphine is a partial opioid
  agonist that has been widely used by the sublingual and transdermal routes of administration, but was believed to be ineffective
  by the oral route. We have completed a preclinical program to better define the pharmacokinetic profile of BuTab and to assess
  the time course of systemic absorption of buprenorphine using several different oral modified release formulations of buprenorphine
  in dogs, compared to an intravenous administration. Based on the results of this work, we have obtained approval from Health Canada
  to initiate a Phase I pharmacokinetic study in healthy volunteers in the second quarter of 2015. This trial is ongoing.
  Chronic
  Pain Indication
  The
  first buprenorphine formulation for the treatment of chronic pain was approved in 2010. Purdue Pharmaceuticals received FDA approval
  for Butrans® (buprenorphine transdermal system) in July. Butrans® is indicated for the management of moderate to severe
  chronic pain and delivers buprenorphine transdermally (through the skin) over a period of seven days. The approval of Butrans®
  signaled the interest and approvability of new formulations of buprenorphine. It is our view that a traditional oral tablet that
  is ingested and absorbed through the intestine will make it a preferred formulation for a significant number of patients with
  chronic pain conditions. Butrans® was launched in early 2011. Sales of Butrans® in 2014 totaled over $192 million and
  continue to steadily grow. Other formulations of buprenorphine are in development for the treatment of pain.
  In
  August 2014, the U.S. Drug Enforcement Administration (DEA) published in the Federal Register their final ruling moving hydrocodone
  combination products (such as Vicodin, Lortab, Norco, etc.) from Schedule III to the more-restrictive Schedule II, as recommended
  by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA's
  own evaluation of relevant data. As a result of the ruling, hydrocodone containing products are now classified in the same category
  (Schedule II) as morphine and oxycodone. As a result of the change to Schedule II, access to these products will be more restricted.
  Among other changes, written prescriptions will be required and refills will not be permitted. The ruling also conveyed findings
  that hydrocodone combination products have a higher risk of abuse and addiction compared to Schedule III products. The ruling
  went into full effect in October 2014.
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  Buprenorphine
  is one of the few remaining Schedule III opioids and has a lower risk of abuse and addiction compared to Schedule II opioids and
  thus will have fewer restrictions on dispensing. BuTab has the opportunity to provide a Schedule III option for the treatment
  of chronic pain and thus helping to replace the void left from the hydrocodone combination products. We believe the actions taken
  to restrict the use of hydrocodone combination products may markedly increase the utility and appeal of BuTab as it could address
  an important unmet medical need for Schedule III options.
  In
  December 2014, BioDelivery Sciences and Endo Pharmaceuticals, Inc. announced the NDA submission for BELBUCA™ for moderate
  to severe chronic pain, which was accepted by FDA in February 2015. BELBUCA™ is subject to a ten month FDA review, which
  could result in an approval in the fourth quarter of 2015 and allow for product launch in early 2016.
  Opioid
  Addiction Indication
  Maintenance
  treatment with buprenorphine reduces the typical cravings and withdrawal symptoms associated with coming off opioid prescription
  painkillers and heroin. This allows the individual suffering from an addiction to opioids –along with counseling and support
  – to work toward recovery. On average, treatment lasts a couple months, reflecting relatively high dropout rates, but a
  significant number of people remain on buprenorphine treatment chronically, with nearly one-quarter of patients still on therapy
  after nine months.
  The
  total market for buprenorphine containing products for opioid dependence approached $1.8 billion in 2014. The market has grown
  significantly as a result of the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin
  use, the growing number of physicians treating opioid dependence, and the inclusion of addiction treatment as an essential benefit
  in the Affordable Care Act.
  The
  products currently marketed for this indication include Suboxone®, a sublingual film formulation of buprenorphine and naloxone,
  a sublingual tablet, Zubsolv®, and generic formulations of buprenorphine/naloxone tablets. Suboxone® film, the market
  leader, achieved sales of nearly $1.2 billion in the U.S. in 2014. While maintaining its dominance as the market leader in the
  U.S., Suboxone® film experienced a decline in sales and share due to increased use of generics and the availability of newer
  formulation of buprenorphine/naloxone. In December 2014, Reckitt Benckiser Group PLC, the manufacturer of Suboxone® sublingual
  tablets and films, announced that they completed the spin-off of that company's pharmaceutical business (including the Suboxone®
  brand) under the name Indivior PLC in order to allow the consumer goods group to focus on its consumer health and hygiene products.
  The Indivior business will focus on addiction treatment and closely related areas including opioid overdose, cocaine overdose
  and alcohol dependence. In September 2012, Reckitt Benckiser announced that it had notified the FDA that they would be voluntarily
  discontinuing the distribution of Suboxone® tablets in the U.S. and subsequently halted further shipments in March 2013. The
  decision made by Reckitt Benckiser was reportedly due to accumulating data demonstrating significantly lower rates of accidental
  pediatric exposure with Suboxone® films compared with their tablet formulation due to the child-resistant, unit-dose packaging
  of the film versus a multi-dose bottle for the tablets. Additionally, Reckitt Benckiser filed a Citizens Petition to request that
  the FDA require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence to implement public
  health safeguards including child-resistant, unit-dose packaging to reduce the risk of pediatric exposure. FDA subsequently rejected
  the Citizens Petition in February 2013, which allowed for the approval of the first generic formulations of Suboxone® tablets.
  The
  actions taken by Reckitt Benckiser as well as patient preference for a film formulation of Suboxone® resulted in significant
  conversion of the Suboxone® market to the branded film formulation. In 2013, the sublingual film formulation of Suboxone®
  accounted for over 95% of total Suboxone® prescription sales.
  Generic
  buprenorphine/naloxone tablet formulations were launched in early 2013 by Actavis and Amneal Pharmaceuticals and were followed
  by additional entrants including a generic formulation from Teva. The remaining prescription volume for Suboxone® tablets
  was rapidly converted to generics; however, the impact of generic buprenorphine/naloxone tablets on Suboxone® film sales has
  been somewhat limited to date. In 2014, generic buprenorphine/naloxone tablets accounted for 18% of total buprenorphine/naloxone
  sales. It is anticipated that additional generics may enter the market, though the timing is unclear.
  In
  June 2014, BioDelivery Sciences received FDA approval for BUNAVAIL® for the maintenance treatment of opioid dependence. BUNAVAIL®
  contains the partial opioid agonist buprenorphine with naloxone, an opioid antagonist, included as an abuse deterrent. When used
  as directed, the naloxone is swallowed and minimally absorbed; however, if misused (ie, dissolved and injected), the naloxone
  rapidly precipitates withdrawal symptoms.
  In
  terms of additional competition, Phase 3 trials were completed for Probuphine, a subcutaneous depot delivery system containing
  buprenorphine from Titan Pharmaceuticals. Results of clinical studies demonstrated efficacy and safety, and Probuphine was submitted
  for FDA review in October 2012. Probuphine was anticipated to address the needs of the subset of patients undergoing treatment
  for opioid dependence who are unable to maintain compliance with alternative formulations or those who may be at high risk for
  diversion. In December 2012, Titan announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl. The license
  grants Braeburn exclusive commercialization rights in the United States and Canada. In April 2013, the FDA issued a Complete Response
  Letter for Probuphine and requested additional data regarding its efficacy. An additional Phase 3 study assessing the efficacy
  and safety of Probuphine was initiated in April 2014. In June 2015, Titan announced that the Phase 3 study of Probuphine for opioid
  addiction met the primary endpoint, allowing for a resubmission of their NDA in late 2015 and potentially securing approval for
  the product in the first half of 2016. Given the need for surgical implantation and removal, Probuphine is not expected to be
  a significant competitive threat to BuTab.
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  A
  sublingual tablet, referred to as Zubsolv® or OX219, was approved by FDA in July 2013 and subsequently launched in September
  2013. Zubsolv® is a sublingual formulation of buprenorphine/naloxone using Orexo's proprietary sublingual drug delivery
  technology. Orexo is a specialty pharmaceutical company with headquarters in Sweden. Orexo is developing treatments using their
  proprietary sublingual drug delivery technology, which includes the marketed product Abstral® that delivers fentanyl for the
  treatment of breakthrough cancer pain. In July 2013 Orexo announced the establishment of a commercial partnership with Publicis
  Healthcare Solutions. In May 2014, Orexo announced a new partnership with InVentiv Health for Zubsolv in the U.S.
  The
  sales efforts for Zubsolv® are supported by a contract sales organization (Inventive Health) and the product is being marketed
  predominantly based on its claims of improved taste and faster dissolve time compared to Suboxone®. Sales for Zubsolv®
  in 2014 totaled approximately $52 million in the U.S and a prescription market share of just over 3%.
  While
  limited information is available, other formulations of buprenorphine may also be in early stages of development for the treatment
  of opioid dependence, including an oral capsule (NTC-510) from Nanotherapeutics, Inc. Three Phase 1 studies have been completed
  to date (two Phase 1a single dose pharmacokinetic studies and one Phase 1b, multidose pharmacokinetic study). It has been demonstrated
  that NTC-510 administered orally achieves appropriate serum buprenorphine concentrations for analgesia and could potentially be
  dosed once daily. Also in development is a sublingual spray formulation of buprenorphine/naloxone from Insys which completed a
  Phase 1 study and buprenorphine hemiadipate (RBP-6300) from Indivior, an oral abuse-deterrent formulation of buprenorphine prodrug
  using Capsugel drug delivery technology.
  While
  we anticipate that the market for buprenorphine/naloxone products for the treatment of opioid dependence will get increasingly
  more competitive, we believe BuTab would have significant appeal given its traditional oral route of administration. We also believe
  that the increased number of companies promoting the use of buprenorphine containing-products for opioid dependence has the potential
  to create greater awareness and help to further expand what is already a significant and growing market.
  MepiGel
  (REL-1021)
  Our
  third-most-advanced novel version of a proven drug product, MepiGel (REL-1021), is a proprietary topical dosage form of the local
  anesthetic mepivacaine for the treatment of painful peripheral neuropathies, such as painful diabetic neuropathy, postherpetic
  neuralgia and painful HIV-associated neuropathy. Mepivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses
  that send pain signals to the brain. It is chemically related to bupivacaine but pharmacologically related to lidocaine. Mepivacaine
  is currently indicated for infiltration, nerve block and epidural anesthesia. Relmada has received two FDA Orphan Drug Designations
  for mepivacaine, one each for "the treatment of painful HIV-associated neuropathy" and for "the management of
  postherpetic neuralgia," or PHN. We have selected the formulations to be advanced into clinical studies for MepiGel after
  the evaluation of results from in vitro and ex vivo studies comparing various topical prototypes of mepivacaine that were conducted
  by MedPharm Ltd, a specialist formulation development company recognized internationally for its expertise in topical and transdermal
  products. Relmada is planning single and multiple dose Phase I studies in healthy subjects with the selected MepiGel formulations.
  The data from these studies will inform the design of a subsequent Phase 2 proof of concept study in patients suffering from neuropathic
  pain.
  Along
  with antidepressants, antiepileptic drugs (AEDs) are often used as a first-line therapy for PHN. The most commonly prescribed
  AEDs for PHN are gabapentin and pregabalin (Lyrica). The choice between them is mostly influenced by physicians' preference
  for the more-favorable dosing attributes (less-frequent daily dosing, faster titration) of pregabalin in balance with price and
  accessibility. AEDs are commonly associated with side effects including somnolence, dizziness, and weight gain. If first-line
  AED or antidepressant monotherapy fails to provide acceptable pain relief, physicians initiate combination therapy. If AED/antidepressant
  combination therapy is not effective, physicians typically add a dual-acting opioid such as tramadol. For more-severe pain, physicians
  may add or switch to tapentadol ER (Nucynta ER). If pain persists with the addition of tramadol or tapentadol, physicians often
  switch to a more potent opioid analgesic (e.g., oxycodone) while maintaining AED and/or antidepressant therapy. Although some
  experts acknowledge that strong opioids can be quite effective for PHN, they generally reserve this drug class for refractory
  cases and/or those with high pain intensity. For some PHN patients, particularly those experiencing highly localized pain, physicians
  may prescribe the lidocaine 5% patch (Lidoderm). Pain specialists generally consider that lidocaine is particularly beneficial
  for localized pain, and many physicians prefer it to oral agents because it does not cause systemic side effects and is easy to
  administer. In many cases, the patch is used in combination with an oral first-line AED and/or antidepressant therapy.
  Acorda
  Therapeutics is developing a concentrated (20%) topical liquid formulation of capsaicin (NP-1998 [formerly NGX-1998]) for the
  treatment of neuropathic pain. The product was formerly in development by NeurogesX, which licensed all U.S. rights as well as
  those of its 8% capsaicin patch (Qutenza) to Accorda in July 2013. Acorda is planning to launch a Phase 3 clinical trial of NP-1998
  in painful HIV (human immunodeficiency virus) peripheral neuropathy as the first potential indication for NP-1998. The company
  is also exploring the potential for additional indications, including painful diabetic neuropathy. In 2011, NeurogesX completed
  a Phase 2 trial in post herpetic neuralgia and results from the trial confirmed efficacy and safety. Teva and Xenon Pharmaceuticals
  are developing TV-45070 (formerly XEN402), a subtype selective ion channel inhibitor. TV-45070 has potentially broad application
  in nociceptive pain, including inflammatory pain, and neuropathic pain indications. TV-45070 is partnered with Teva in a milestone,
  royalty and co-promotion partnership. Using a topical (ointment) formulation of TV-45070, Teva has initiated a 300-patient Phase
  2b clinical trial in osteoarthritis, or OA, of the knee. In July 2015, it was reported that TV-45070 4% and 8% did not demonstrate
  statistically significant difference from placebo in efficacy endpoints in Phase 2b study in pain due to osteoarthritis of the
  knee. Teva is also developing topical TV-45070 in neuropathic pain indications, and is currently planning a Phase 2b clinical
  trial in patients with postherpetic neuralgia.
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  Research
  and Development Expenses
  A
  significant portion of our operating expenses is related to research and development and we intend to maintain our strong commitment
  to research and development. Research and development expense for year ended June 30, 2015, for the six months ended June 30,
  2014 and for the year ended December 31, 2013 was approximately $7,872,400, $840,000 and $5,248,700, respectively.
  Overview
  of the 505(b)(2) Regulatory Pathway
  The
  majority of our drug development pipeline is based on the application of drug delivery technologies and/or new dosage forms/indications
  to existing drugs for the creation of novel products. We then seek proprietary protection and FDA approval, and subsequently plan
  to commercialize these products ourselves or through partners. We believe that research and development efforts focused on novel
  dose forms of FDA approved drugs is less risky than attempting to discover new drugs, sometimes called new chemical entities (known
  as NCEs).
  An
  important part of our strategy is the utilization of FDA's 505(b)(2) NDA process for approval. The 505(b)(2) new drug application
  (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy
  for many companies. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the
  Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication
  of studies already performed on a previously approved ("reference" or "listed") drug; the section gives
  the FDA express permission to rely on data not developed by the NDA applicant.
  A
  505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval,
  such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant.
  This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such
  as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.
  Overview of Orphan Drug Status
  In
  accordance with laws and regulations pertaining to the Regulatory Agencies, a sponsor may request that the Regulatory Agencies
  designate a drug intended to treat a "Rare Disease or Condition" as an "Orphan Drug." For example, in
  the United States, a "Rare Disease or Condition" is defined as one which affects less than 200,000 people in the United
  States, or which affects more than 200,000 people but for which the cost of developing and making available the product is not
  expected to be recovered from sales of the product in the United States. Upon the approval of the first NDA or BLA for a drug
  designated as an orphan drug for a specified indication, the sponsor of that NDA or BLA is entitled to 7 years of exclusive marketing
  rights in the United States unless the sponsor cannot assure the availability of sufficient quantities to meet the needs of persons
  with the disease. In Europe, this exclusivity is 10 years, and in Australia it is 5 years. However, orphan drug status is particular
  to the approved indication and does not prevent another company from seeking approval of an off-patent drug that has other labeled
  indications that are not under orphan or other exclusivities. Orphan drugs may also be eligible for federal income tax credits
  for costs associated with such as the disease state, the strength and complexity of the data presented, the novelty of the target
  or compound, risk-management approval and whether multiple rounds of review are required for the agency to evaluate the submission.
  There is no guarantee that a potential treatment will receive marketing approval or that decisions on marketing approvals or treatment
  indications will be consistent across geographic areas.
  Properties
  We
  do not own any property. As of June 30, 2015, we have a commitment of $30,600 at our previous corporate office location. We temporarily
  moved our corporate office location and have a commitment of approximately $41,600 through September 30, 2015 at 757 Third Avenue,
  Suite 2018, New York, NY 10017. In June 2015, we entered into a seven year
  and three months
  lease at 275 Madison Avenue, Suite 702, New York, NY 10016 for our corporate office location, with an annual rental rate commencing
  at approximately $312,600 per year for the period to commencing in October 2015 through September 2019. The annual rent will increase
  to approximately $341,600 commencing in October 2019 through the end of the lease term.
  We also lease an office at Village
  Square Professional Building Two, 686 DeKalb Pike, Suite 202, Blue Bell, PA 19422 for approximately $3,100, expiring September,
  2017. We entered into a sublease agreement through September 2016 whereby a tenant will be reimbursing us $2,350 for rent
  per month.
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  Our
  Corporate History and Background
  We
  are a clinical stage biopharmaceutical company focused on developing a pipeline of drug candidates to treat chronic pain.
  Relmada
  Therapeutics, Inc. ("RTI"), which was previously a private company commenced operations in May 2004, entered into
  a Merger Agreement with Medeor Inc. ("Medeor") on December 31, 2013. This transaction occurred by the exchange of
  Medeor's shares, for RTI's common stock. Following the transaction, the corporate existence of Medeor ceased and RTI
  continued as the surviving corporation (the "Merger"). In connection with the Merger, each share of common stock of
  Medeor was converted into the right to receive a pro rata share of RTI's common stock based upon an exchange ratio. Medeor
  was developing d-Methadone.
  In
  May 2014, RTI completed a Share Exchange with Camp Nine, Inc., a publicly traded Nevada corporation that was formed in May 2012.
  In July 2014, we changed the name of Camp Nine, Inc. to Relmada Therapeutics, Inc. At the Share Exchange, RTI shareholders exchanged
  10 shares of RTI common stock for one share of our common stock. As a result of the Share Exchange, RTI's shareholders acquired
  the majority of our issued and outstanding capital stock and RTI became our subsidiary.
  The
  Share Exchange was accounted for as a "reverse merger" rather than a business combination, wherein Relmada is considered
  the acquirer for accounting and financial reporting purposes. The statement of operations reflects the activities of RTI from
  the commencement of its operations since inception. Unless the context suggests otherwise, when we refer in this Report to business
  and financial information for periods prior to the consummation of the Share Exchange, we are referring to the business and financial
  information of RTI.
  During
  the six months ended June 30, 2014, we changed our year-end to June 30 and increased its authorized common stock to 500,000,000
  shares and its authorized preferred stock to 200,000,000 shares of which 3,500,000 is designated for Class A preferred stock.
  On August 12, 2015, the Company completed a one-for-five reverse stock split in preparation for our proposed up-listing to NASDAQ
  Capital Markets reducing the authorized common share to 100,000,000 common shares. This Annual Report reflects a retroactive adjustment
  for the reverse stock split.
  Currently,
  none of our drugs have been approved for sale in the United States or elsewhere. We have no commercial products nor do we have
  a sales or marketing infrastructure. In order to market and sell our products we must conduct clinical trials on patients and
  obtain regulatory approvals from appropriate regulatory agencies, like the FDA in the United States, and similar organizations
  elsewhere in the world.
  We
  have not generated revenues and do not anticipate generating revenues for the foreseeable future. We had net loss of approximately
  $20,803,600, $21,336,000 and $19,871, 900 for the year ended June 30, 2015, for the six months ended June 30, 2014 and for the
  year ended the year ended December 31, 2013, respectively. At June 30, 2015, we have an accumulated deficit of approximately
  $76,122,200.
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  Business
  Strategy
  Our
  strategy is to leverage our considerable industry experience, understanding of pain markets and development expertise to identify,
  develop and commercialize product candidates with significant market potential that can fulfill unmet medical needs in the treatment
  of pain.
  We
  plan to further develop our novel, proprietary drug products via the 505(b)(2) development pathway and also to gain exclusivity
  under the Hatch-Waxman Act for new indications and also orphan drug designation in certain indications. We plan to also generate
  intellectual property (IP) that will further protect our products from competition. As the drug d-Methadone is not an already
  approved product by the FDA, the regulatory pathway to approval will be the more traditional NDA development, which may consist
  of conducting a full clinical development program. We will continue to prioritize our product development activities after taking
  into account the resources we have available, market dynamics and potential for adding value. We will continue to outsource development
  of our products, while retaining scientific, operational and financial oversight and control.
  We
  intend to seek and execute licensing and/or co-development agreements with companies capable of supporting the final stage development
  of the Company's products and their subsequent commercialization in the U.S. and international markets. We may also
  develop our own internal sales and marketing capabilities to commercialize some or all of our products to selected specialty medical
  segments in the U.S. while out-licensing sales and marketing for the international market.
  We
  may in-license late-stage or approved drugs to accelerate the pathway to become a fully integrated pain specialty biopharmaceutical
  company with commercial capability. Alternatively, we might consider a trade sale of our products or the entire company if we
  deem that it is in the best interests of our shareholders.
  Market
  Opportunity
  The
  pain market is well established, with many pharmaceutical companies marketing innovative products as well as generic versions
  of older, non-patent protected products. In 2014, according to data from IMS Health, there were 328 million pain prescriptions
  representing $13 billion in annual sales in the U.S.
  7
  Table of Contents
  Analgesics
  continue to be among the most widely prescribed medications and there is little to suggest that their preeminence will change
  in the near future, given the prominent role of pain in many diseases. Survey data indicate substantial patient dissatisfaction
  with current pain management modalities. According to the Chronic Pain in America Study published in 1999 by AAPM, APS, and Jansen
  and the Voice of Chronic Pain Survey by the American Pain Foundation in May 2006; only 55% of patients with chronic pain feel
  their pain is "under control" and only 23% believe their pain medications are "very effective." According
  to IMS Health, the U.S. opioid market was worth approximately $8.3B in 2013, with ER (Extended Release) opioids accounting for
  approximately $4.8B in sales. Significant market value has been maintained in the presence of low-cost high-volume generics over
  the last two decades through the introduction of new products that were approved via the 505(b)(2) FDA approval route. These products
  are branded and differentiated formulations such as fixed dose combinations, extended-release products, transdermal patches, etc.
  and thus provide both market exclusivity and the possibility of a high price point. Per Decision Resources, the cost of therapy
  for branded ER opioids is approximately $11.00 per day versus generics which cost $3.00 per day. Our ER opioids LevoCap ER and
  BuTab are pharmacologically differentiated from commercially available immediate release (IR) opioids, including OxyContin®,
  Embeda®, Opana® ER, Duragesic®, Avinza®, Kadian®, Remoxy® & Exalgo®. Many patients with neuropathic
  pain have suboptimal relief with monotherapy and treatment is frequently multimodal, involving use of two or more drugs from different
  pharmacologic classes. Our topical local anaesthetic mepivacaine and oral d-Methadone are anticipated to be used for the treatment
  of painful peripheral neuropathies. According to Decision Resources, the market for neuropathic pain drugs is expected to grow
  to $9.7B by 2018 in the U.S. According to GlobalData, the U.S. neuropathic pain market consists of approximately 4.7M patients
  and is expected to grow to more than 6.1M patients in 2018. d-Methadone is anticipated to compete with the current available therapies
  for neuropathic pain, including Cymbalta® which had $5.1B in worldwide 2013 sales, according to Eli Lilly 2013 annual report
  Lyrica® which had $4.6B in worldwide 2013 sales, according to Pfizer 2013 annual report and lidocaine patch which had $1.28B
  in U.S. 2014 sales, according to IMS Health including generics.
  Our
  orphan designated topical MepiGel is anticipated to compete with topical lidocaine patch with $1.28B according to ISM which includes
  generic drugs in U.S. 2014 sales and may also be used in combination with oral therapies for neuropathic pain. MepiGel is developed
  for the relief of pain associated with post-herpetic neuralgia which is the same indication as that of the topical Lidocaine patch.
  Hence, we believe that MepiGel is anticipated to compete with the Lidocaine patch. Lidocaine patch is the only topical local anaesthetic
  approved for the treatment of neuropathic pain. Lidocaine patch provides only modest pain relief in patients with postherpetic
  neuralgia. According to the March 2010 issue of UK National Institute of Health and Clinical Excellence (NICE) clinical guideline
  on neuropathic pain, there is a "lack of evidence for the efficacy of topical lidocaine for treating neuropathic pain"
  and topical lidocaine should be considered as "third line" treatment for neuropathic pain.
  Intellectual
  Property Portfolio and Market Exclusivity
  We
  have secured Orphan Drug Designation from the FDA for MepiGel for "the treatment of painful HIV-associated neuropathy"
  and for "the management of postherpetic neuralgia" which would, upon NDA approval, carry 7-year FDA Orphan Drug marketing
  exclusivity. In the European Union, some of our products may be eligible up to 10 years of market exclusivity which includes 8
  years data exclusivity and 2 years market exclusivity. In addition to any granted patents, our products will be eligible for market
  exclusivity to run concurrently with the term of the patent for 3 years in the U.S. (Hatch Waxman plus pediatric exclusivity)
  and up to 10 years of in the E.U. We believe an extensive intellectual property estate of several patents will protect our technology
  and products once our patent applications for our products are approved.
  The
  following is a summary of our patents and patent applications:
  Levorphanol:
  These patent applications cover the Levorphanol product.
  Patent
  application 12/223.327 filed 1/29/07, Abuse Resistant and Extended Release Formulations and Method of Use Thereof. Currently pending.
  Patent
  application 12/597,702 filed 4/28/08, Multimodal Abuse Resistant and Extended Release Opioid Formulations. Currently claims are
  allowed. Issued fee paid.
  Patent
  application 13/320,9889 filed 2/26/10, Extended Release Oral Pharmaceutical Compositions of 3-Hydroxy-N-Methylmorphinan and Method
  of Use. Currently pending.
  d-Methadone:
  These patent and patent application cover the d-Methadone product.
  Patent
  No. 6,008,258 filed 1/21/98, d-Methadone, a Nonopioid Analgesic, Patent granted.
  Patent
  application 13/803,375 filed 3/14/13, d-Methadone for the Treatment of Psychiatric Symptoms. Currently pending.
  Buprenorphine:
  This patent application covers the buprenorphine product.
  Patent
  application 12/988,209 filed 3/9/09, Oral Pharmaceutical Compositions of Buprenorphine and Method of Use. Currently pending.
  Mepivacaine
  :
  This patent application covers the Mepivacaine product.
  Patent
  application PCT/US2011/032,381 filed 4/13/11, Dermal Pharmaceutical Composition of 1-Methyl-2',6'-Pipecoloxylidide
  and Method of Use. Currently pending.
  8
  Table of Contents
  Key
  Strengths
  We
  believe that the key elements for our market success include:
  ●
  A multiple product portfolio with a balanced risk reward profile:
      We have four products at various stages of development, and each has its own development risk profile and indication. Accordingly,
      management believes that we are well positioned to become a competitive player in a large unsatisfied market.
  ●
  Products are differentiated and address significant unmet needs:
      All four lead development programs are well differentiated value added pain drugs that address significant unmet medical needs.
      Pain management remains a critical area of unmet medical need. Increasingly, patients, advocacy groups, pain related professional
      organizations and the media are highlighting the limitations of pain management and are demanding changes in the medical system.
      Neuropathic pain in particular is a large and unsatisfied segment where d-Methadone could play an important role. In addition,
      the abuse potential of leading pain medications such as the OxyContin franchise, Vicodin, etc. has been reported extensively.
      Our LevoCap ER dosage form is designed to deter the manipulation for intravenous, intranasal or inhalational use, and for
      oral ingestion to provide high peak concentrations to opioid addicts and recreational drug users.
  ●
  Scientific support of leading experts: Our scientific advisory
      board includes clinicians and scientists who are affiliated with a number of highly regarded medical institutions. The board
      consists of individuals who have served as executives of leading national and international societies in pain, rheumatology
      and the FDA.
  ●
  Efficient development strategy: The 505(b) (2) pathway lowers
      the risk of drug development. Our strategy of combining proven drug candidates with novel delivery methods and pharmaceutical
      compositions reduces clinical development time and costs and lowers regulatory risks, while delivering valuable products in
      areas of high unmet need to the market place. Abuse resistant and once a day formulations improve the commercial potential
      of opioids, addressing the risk of opioid abuse and opioid diversion by making the dosage form tamper resistant, thereby frustrating
      attempts at physical manipulation of the dosage.
  ●
  Substantial IP portfolio and market protection: Upon the approval
      of our filed patent applications for our products we will have secured an intellectual property portfolio comprised of several
      patents. In addition, some of our drugs have also been designated as Orphan Drugs by the FDA, thereby providing seven years
      of market exclusivity at launch.
  ●
  Experienced management: We combine business expertise with what
      we believe is an internationally recognized research team. We believe our highly experienced drug development leadership provides
      us with a significant competitive advantage in designing highly efficient clinical programs with predictable regulatory outcomes.
  Competition
  Overview
  The
  pharmaceutical and biotechnology industry is characterized by intense competition, rapid product development and technological
  change. Competition is intense among manufacturers of prescription pharmaceuticals and other product areas where we may develop
  and market products in the future. Most of our competitors are large, well established pharmaceutical or healthcare companies
  with considerably greater financial, marketing, sales and technical resources than are available to us. Additionally, many of
  our competitors have research and development capabilities that may allow such competitors to develop new or improved products
  that may compete with our products. Our products could be rendered obsolete or made uneconomical by the development of new products.
  Regarding
  our competitive position in the industry, none of our products have been approved for sale.
  The
  pain market has peculiar characteristics with regards to competition. While there are several products in development both in
  the narcotic and neuropathic pain space, the market history has shown that a new entry in the therapeutic area does not necessarily
  cannibalize existing products, but instead expands the market. The reasons behind this behavior can be found in the "opioid
  rotation" phenomena. As there is considerable variability in the efficacy and side effect response of patients to opioid
  analgesics, many patients rotate from one opioid to another, offering growth opportunity to new entries. In the case of the neuropathic
  pain indication, it is mostly the limited efficacy of the existing therapies that creates a strong demand for new entries, a model
  also supported by the considerable off-label use of opioids, tricyclic antidepressant and NSAIDS in neuropathic pain.
  Because
  of the large opportunity, the current competitive landscape includes a significant number of pharmaceutical companies such as
  Pfizer, Johnson & Johnson, Eli Lilly, Endo Pharmaceutical Holding, Purdue Pharma, Mallinckrodt, DepoMed, and Teva Pharmaceutical.
  In
  addition to the marketed drugs, we expect competition from product candidates that are or will be in development by the companies
  mentioned above and others. We are aware that several companies not mentioned before are working on new delivery forms of pain
  products and abuse deterrent formulations, including Acura Pharmaceutical, BioDelivery Science, Collegium Pharmaceutical, Egalet
  A/S, Elite Pharmaceutical, Inspirion Delivery Technologies, and Intellipharmaceutics International.
  9
  Table of Contents
  Government
  Regulation
  Governmental
  authorities in the United States and other countries extensively regulate, among other things, the research, development, testing,
  manufacture, labeling, promotion, advertising, distribution and marketing of active pharmaceutical ingredients, excipients, controlled
  substances and finished pharmaceutical products such as those being developed by Relmada.
  In
  the United States, the FDA regulates such products under the Federal Food, Drug and Cosmetic Act (FDCA), as amended and regulations
  pursuant to the FDCA.
  The
  U.S. Drug Enforcement Agency (DEA), a division of the Department of Justice, administers the federal Controlled Substances Act
  ("CSA") of 1970, as amended. The CSA imposes various registration, record-keeping and reporting requirements, procurement
  and manufacturing quotas, import and export controls, labeling and packaging requirements, security controls, and a restriction
  on prescription refills on certain pharmaceutical products.
  To
  meet its responsibilities, the DEA conducts periodic inspections of registered establishments that handle controlled substances.
  Failure of companies to maintain compliance, particularly as manifested in loss or diversion, can result in regulatory action
  including civil and criminal penalties, refusal to renew necessary registrations, or initiating proceedings to revoke those registrations.
  If a manufacturer or distributor has its registration revoked, it can no longer lawfully possess or distribute controlled substances
  meaning effectively that the operations of such an organization must cease with respect to controlled substances. In certain circumstances,
  violations also can lead to criminal proceedings.
  Most
  states impose similar controls over controlled substances under state law as regulated by the Board of Pharmacy or other state
  regulatory authorities.
  The
  U.S. Federal Trade Commission (FTC) and the Office of the Inspector General of the U.S. Department of Health and Human Services
  (HHS) also regulate certain pharmaceutical marketing practices. Thus, reimbursement practices of the HHS covering medicine and
  medical services are important to the success of our products.
  We
  are also subject to United States regulation under the Controlled Substances Act ("CSA"). Drug Enforcement Administration
  regulations require Scheduled II controlled substances to be manufactured in the United States if the products are to be marketed
  in the United States. Our only products that contain Schedule II controlled substances are LevoCap-ER and d-Methadone. We are
  in the process of transferring all third party manufacturing of these products to the United States, and we intend to comply with
  this CSA requirement.
  We
  are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing
  practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances.
  Failure
  to comply with applicable FDA, DEA, FTC, HHS and other federal and state regulations and requirements, both before and after drug
  approval may subject us to administrative and judicial sanctions, such as a delay in approving or refusal by the FDA to approve
  pending applications, warning letters, product recalls, product seizures, total or partial suspension of production or distribution,
  injunctions, fines and/or criminal prosecution.
  Relmada
  believes that a two tiered approach can reduce overall clinical development risks. Our approach consists of: (1) developing improved
  versions of proven drug candidates and filings under 505(b)(2) which may require an abbreviated clinical development program;
  and (2) developing a drug in treating conditions that have not been approved by the FDA, and filings under the traditional NDA
  which would require a full clinical development program. In general, drugs for the 505(b)(2) filing possess less risks as compared
  to drugs filed under the traditional NDA route. As with all drugs filed with the FDA, there is no guarantee of approval.
  Please
  see "Company Overview" above for a status of our drug development.
  U.S.
  Food and Drug Administration Regulation
  Our
  research, development and clinical programs, as well as our manufacturing and marketing operations, are subject to extensive regulation
  in the United States and other countries. Most notably, all of our products sold in the United States are subject to the FDCA
  as implemented and enforced by the FDA. Certain of our product candidates in the United States require FDA pre-marketing approval
  of an NDA pursuant to 21 C.F.R. § 314. Foreign countries may require similar or more onerous approvals to manufacture or
  market these products.
  Failure
  by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA, the DEA
  or other regulatory authorities, which may result in sanctions including, but not limited to: untitled letters, warning letters,
  fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recall, detention
  or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying
  our requests for NDA premarket approval of new products or modified products; withdrawing NDA approvals that have already been
  granted; refusal to grant export approval for our products; or criminal prosecution.
  Corporate
  Information
  Our
  principal executive office is located at 757 Third Avenue, New York, NY 10017 and our telephone number is (212) 376-5776. Our
  website address is
  www.relmada.com.
  Information accessed through our website is not incorporated into this prospectus
  and is not a part of this prospectus.
  10
  Table of Contents
  The
  Offering
  Common stock offered by selling stockholders
  847,147
  shares of our common stock (i) underlying outstanding options and restricted stock previously granted under the Relmada Therapeutics,
  Inc 2014 Stock Option and Equity Incentive Plan, as amended (the "Plan") to the selling stockholders.
  Use of proceeds
  We will not receive any proceeds
      from the sales of these shares.  We will receive proceeds to the extent that options to purchase common stock may be
      issued and thereafter exercised.  We will use the exercise proceeds, if any, for working capital and general corporate
      purposes.
  Trading Symbol
  RLMD
  Risk Factors
  The common stock offered hereby involves
      a high degree of risk and should not be purchased by investors who cannot afford the loss of their entire investment.  You
      should carefully consider the risk factors described in this prospectus in the "Risk Factors" section before making
      a decision to invest.
  11
  Table of Contents
  RISK
  FACTORS
  An
  investment in our common stock involves a high degree of risk. You should carefully consider the risks described below, together
  with all of the other information included in this report, before making an investment decision. If any of the following risks
  actually occurs, our business, financial condition or results of operations could suffer. In that case, the trading price of our
  shares of common stock could decline, and you may lose all or part of your investment. You should read the section entitled "Forward-Looking
  Statements" above for a discussion of what types of statements are forward-looking statements, as well as the significance
  of such statements in the context of this prospectus.
  Risk
  Related to Our Business
  Our
  product candidates are in early stages of clinical testing.
  Our product
  candidates are still in the early stages of clinical testing. None has gone beyond the Phase I/Phase IIa stage and FDA approval
  requires that a drug candidate complete a Phase III study program, to test the safety and efficacy of the drug candidate on a
  large sample of patients. The timeline between a Phase I study and a Phase III study and subsequent filing of a New Drug Application
  can be several years. We will need to commit substantial time and additional resources to conducting further nonclinical studies
  and clinical trials before we can submit an NDA with respect to any of these product candidates. We cannot predict with any certainty
  if or when we might submit an NDA for regulatory approval of any of our product candidates.
  We
  have generated no revenue from commercial sales to date and our future profitability is uncertain.
  We have
  a limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise.
  Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently
  encountered in connection with this. Since we began our business, we have focused on research, development and clinical trials
  of product candidates, and have incurred significant losses since inception and generated no product revenues. If we continue
  to incur operating losses and fail to become a profitable company, we may be unable to continue our operations. We expect to continue
  to operate at a net loss for at least the next several years as we continue our research and development efforts, continue to
  conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities. There can be no assurance that
  the products under development by us will be approved for sales in the US or elsewhere. Furthermore, there can be no assurance
  that if such products are approved they will be successfully commercialized, and the extent of our future losses and the timing
  of our profitability are highly uncertain.
  International
  commercialization of our product candidates faces significant obstacles.
  We may plan
  to commercialize some of our products internationally through collaborative relationships with foreign partners. We have limited
  foreign regulatory, clinical and commercial resources. Future partners are critical to our international success. We may not be
  able to enter into collaboration agreements with appropriate partners for important foreign markets on acceptable terms, or at
  all. Future collaborations with foreign partners may not be effective or profitable for us. We will need to obtain approvals from
  the appropriate regulatory, pricing and reimbursement authorities to market any of our proposed products internationally, and
  we may be unable to obtain foreign regulatory approvals. Pursuing foreign regulatory approvals will be time-consuming and expensive.
  The regulations can vary among countries and foreign regulatory authorities may require different or additional clinical trials
  than we conducted to obtain FDA approval for our product candidates. In addition, adverse clinical trial results, such as death
  or injury due to side effects, could jeopardize not only regulatory approval, but if approval is granted, may also lead to marketing
  restrictions. Our product candidates may also face foreign regulatory requirements applicable to controlled substances.
  We
  need to raise additional capital to operate our business
  .
  We are a
  company focused on product development and have not generated any product revenues to date. Until, and if, we receive approval
  from the FDA and other regulatory authorities for our product candidates, we cannot sell our drugs and will not have product revenues.
  Therefore, for the foreseeable future, we will have to fund all of our operations and capital expenditures from the net proceeds
  of future offerings and grants. We believe with our cash and cash equivalents on hand at June 30, 2015 of approximately $22,470,000
  we can fund our operations until the end of calendar year 2016. Our actual capital requirements will depend on many factors. If
  we experience unanticipated cash requirements, we may need to seek additional sources of financing, which may not be available
  on favorable terms, if at all. If we do not succeed in raising additional funds on acceptable terms, we may be unable to complete
  planned nonclinical studies and clinical trials or obtain approval of our product candidates from the FDA and other regulatory
  authorities. In addition, we could be forced to discontinue product development, reduce or forego sales and marketing efforts
  and attractive business opportunities, or discontinue operations.
  We
  have a history of losses and we may never achieve or sustain profitability.
  We have
  incurred substantial losses since our inception, and we may not achieve profitability for the foreseeable future, if at all. We
  have incurred an accumulated loss of approximately $76,100,200, which includes non-cash expenses of approximately $47,565,700.
  The Company has cash and cash equivalents of approximately $22,470,000 at June 30, 2015. Even if we succeed in developing and
  commercializing one or more of our product candidates, we expect to incur substantial net losses and negative cash flows for the
  foreseeable future due in part to increasing research and development expenses, including clinical trials, and increasing expenses
  from leasing additional facilities and hiring additional personnel. As a result, we will need to generate significant revenues
  in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the
  future. Even if we do achieve profitability, we may not be able to sustain or increase profitability.
  12
  Table of Contents
  We
  have a limited operating history upon which to base an investment decision.
  Our limited
  operating history may limit your ability to evaluate our prospects due to our limited historical financial data and our unproven
  potential to generate profits. You should evaluate the likelihood of financial and operational success in light of the risks,
  uncertainties, expenses and difficulties associated with an early-stage business, many of which may be beyond our control, including:
  ●
  our potential
      inability to continue to undertake nonclinical studies, pharmaceutical development and clinical trials,
  ●
  our potential
      inability to obtain regulatory approvals, and
  ●
  our potential
      inability to manufacture, sell and market our products.
  Our operations
  have been limited to organizing and staffing, on a limited basis, our company, acquiring, developing and securing our proprietary
  technology and undertaking nonclinical studies and early stage clinical trials of our principal product candidates. These operations
  provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing
  in our common stock.
  If
  we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development
  and you will likely lose your entire investment.
  We will
  need to continue to seek capital from time to time to continue for the development beyond of our product that are in Phase I and
  II clinical trials. We also may acquire and develop other product candidates. Our first product is not expected to be commercialized
  until at least 2018 and the revenues it will generate may not be sufficient to fund our ongoing operations. The Company believes
  that with current cash on hand it will be able to fund the Company's operations until end of calendar year 2016. Accordingly,
  we believe that we will need to raise substantial additional capital to fund our continuing operations and the development and
  commercialization of our product candidates in the second half of 2015. Our business or operations may change in a manner that
  would consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain operations,
  fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or otherwise respond
  to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred pain treatment
  modalities. In addition, we may need to accelerate the growth of our sales capabilities and distribution beyond what is currently
  envisioned and this would require additional capital. However, we may not be able to secure funding when we need it or on favorable
  terms. If we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale-back or eliminate our
  research and development activities, clinical studies or future operations. We may also be required to obtain funds through arrangements
  with collaborators, which arrangements may require us to relinquish rights to certain technologies or products that we otherwise
  would not consider relinquishing, including rights to future product candidates or certain major geographic markets. We may further
  have to license our technology to others. This could result in sharing revenues which we might otherwise retain for ourselves.
  Any of these actions may harm our business, financial condition and results of operations.
  The amount
  of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;
  the progress, timing and scope of our nonclinical studies and clinical trials; the time and cost necessary to obtain regulatory
  approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our
  ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners' commitment
  of time and resource to the development and commercialization of our products.
  We
  have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on terms that
  are dilutive to you.
  We have
  limited access to the capital markets to raise capital. The capital markets have been unpredictable in the recent past for other
  pain companies and unprofitable companies such as ours. In addition, it is generally difficult for companies to raise capital
  under current market conditions. The amount of capital that a company such as ours is able to raise often depends on variables
  that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we are
  able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds
  are not available on acceptable terms, or at all, our business, results of operations, financial condition and our continued viability
  will be materially adversely affected.
  13
  Table of Contents
  Risks
  Related to Clinical and Regulatory Matters
  If
  we or our potential collaborators fail to obtain the necessary regulatory approvals, or if such approvals are limited, we and
  our potential collaborators will not be allowed to commercialize our drug candidates, and we will not generate product revenues.
  Satisfaction
  of all regulatory requirements for commercialization of a drug candidate typically takes many years, is dependent upon the type,
  complexity and novelty of the drug candidate, and requires the expenditure of substantial resources for research and development.
  Our research and clinical approaches may not lead to drugs that the FDA considers safe for humans and effective for indicated
  uses we are studying. The FDA may require additional studies, in which case we or our collaborators would have to expend additional
  time and resources and would likely delay the date of potentially receiving regulatory approval. The approval process may also
  be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur
  prior to or during our regulatory review. Delays in obtaining regulatory approvals would:
  ●
  delay commercialization
      of, and product revenues from, our drug candidates; and
  ●
  diminish the competitive
      advantages that we may have otherwise enjoyed, which would have an adverse effect on our operating results and financial condition.
  Even if
  we or our collaborators comply with all FDA regulatory requirements, our drug candidates may never obtain regulatory approval.
  If we or our collaborators fail to obtain regulatory approval for any of our drug candidates we will have fewer commercial products,
  if any, and corresponding lower product revenues, if any. Even if our drug candidates receive regulatory approval, such approval
  may involve limitations on the indications and conditions of use or marketing claims for our products. Further, later discovery
  of previously unknown problems or adverse events could result in additional regulatory restrictions, including withdrawal of products.
  The FDA may also require us or our collaborators to commit to perform lengthy Phase IV post-approval clinical efficacy or safety
  studies. Our expending additional resources on such trials would have an adverse effect on our operating results and financial
  condition.
  In jurisdictions
  outside the United States, we or our collaborators must receive marketing authorizations from the appropriate regulatory authorities
  before commercializing our drugs. Regulatory approval processes outside the United States generally include all of the aforementioned
  requirements and risks associated with FDA approval.
  If
  we or our collaborators are unable to design, conduct and complete clinical trials successfully, our drug candidates will not
  be able to receive regulatory approval.
  In order
  to obtain FDA approval for any of our drug candidates, we or our collaborators must submit to the FDA an NDA that demonstrates
  with substantive evidence that the drug candidate is both safe and effective in humans for its intended use. This demonstration
  requires significant research and animal tests, which are referred to as preclinical studies, as well as human tests, which are
  referred to as clinical trials.
  Results
  from Phase I clinical programs may not support moving a drug candidate to Phase II or Phase III clinical trials. Phase III clinical
  trials may not demonstrate the safety or efficacy of our drug candidates. Success in preclinical studies and early clinical trials
  does not ensure that later clinical trials will be successful. Results of later clinical trials may not replicate the results
  of prior clinical trials and preclinical studies. Even if the results of Phase III clinical trials are positive, we or our collaborators
  may have to commit substantial time and additional resources to conducting further preclinical studies and clinical trials before
  obtaining FDA approval for any of our drug candidates.
  Clinical
  trials are very expensive and difficult to design and implement, in part because they are subject to rigorous requirements. The
  clinical trial process also consumes a significant amount of time. Furthermore, if participating patients in clinical trials suffer
  drug-related adverse reactions during the course of such clinical trials, or if we, our collaborators or the FDA believe that
  participating patients are being exposed to unacceptable health risks, such clinical trials will have to be suspended or terminated.
  Failure can occur at any stage of the clinical trials, and we or our collaborators could encounter problems that cause abandonment
  or repetition of clinical trials.
  Our clinical
  trials and our future clinical trials for other drug candidates for treatment of pain measure clinical symptoms, such as pain
  and physical dependence that are not biologically measurable. The success in clinical trials and our other drug candidates designed
  to reduce risks of unintended use depends on reaching statistically significant changes in patients' symptoms based on clinician-rated
  scales. Due in part to a lack of consensus on standardized processes for assessing clinical outcomes, these scores may or may
  not be reliable, useful or acceptable to regulatory agencies.
  We have
  no history of developing drug candidates. We do not know whether any of our planned clinical trials will result in marketable
  drugs.
  In addition,
  completion of clinical trials can be delayed by numerous factors, including:
  ●
  delays in identifying
      and agreeing on acceptable terms with prospective clinical trial sites;
  ●
  slower than expected
      rates of patient recruitment and enrollment;
  ●
  unanticipated
      patient dropout rates;
  ●
  increases in time
      required to complete monitoring of patients during or after participation in a clinical trial; and
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  Any of these
  delays could significantly impact the timing, approval and commercialization of our drug candidates and could significantly increase
  our overall costs of drug development.
  Even if
  clinical trials are completed as planned, their results may not support expectations or intended marketing claims. The clinical
  trials process may fail to demonstrate that our drug candidates are safe and effective for indicated uses. Such failure would
  cause us to abandon a drug candidate and could delay development of other drug candidates.
  With
  respect to the Phase III clinical trial, these discussions are not binding obligations on the part of regulatory authorities.
  Regulatory
  authorities may revise previous guidance or decide to ignore previous guidance at any time during the course of our clinical activities
  or after the completion of our clinical trials. Even with successful clinical safety and efficacy data, including such data from
  a clinical trial conducted pursuant to an SPA, we or our collaborators may be required to conduct additional, expensive clinical
  trials to obtain regulatory approval.
  Developments
  by competitors may establish standards of care that affect our ability to conduct our clinical trials as planned.
  Changes
  in standards related to clinical trial design could affect our ability to design and conduct clinical trials as planned. For example,
  regulatory authorities may not allow us to compare our drug candidates to placebo in a particular clinical indication where approved
  products are available. In that case, both the cost and the amount of time required to conduct a clinical trial could increase.
  The
  DEA limits the availability of the active ingredients in certain of our current drug candidates and, as a result, quotas for these
  ingredients may not be sufficient to complete clinical trials, or to meet commercial demand or may result in clinical delays.
  The U.S.
  Drug Enforcement Administration, or DEA, regulates chemical compounds as Schedule I, II, III, IV or V substances, with Schedule
  I substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. Certain active
  ingredients in our current drug candidates, such as oxycodone, are listed by the DEA as Schedule II under the Controlled Substances
  Act of 1970. Consequently, their manufacture, research, shipment, storage, sale and use are subject to a high degree of oversight
  and regulation. For example, all Schedule II drug prescriptions must be signed by a physician, physically presented to a pharmacist
  and may not be refilled without a new prescription. Furthermore, the amount of Schedule II substances that can be obtained for
  clinical trials and commercial distribution is limited by the DEA and quotas for these substances may not be sufficient to complete
  clinical trials or meet commercial demand. There is a risk that DEA regulations may interfere with the supply of the drugs used
  in clinical trials for our product candidates, and, in the future, the ability to produce and distribute our products in the volume
  needed to meet commercial demand.
  Conducting
  clinical trials of our drug candidates or commercial sales of a drug candidate may expose us to expensive product liability claims
  and we may not be able to maintain product liability insurance on reasonable terms or at all.
  The risk
  of product liability is inherent in the testing of pharmaceutical products. If we cannot successfully defend ourselves against
  product liability claims, we may incur substantial liabilities or be required to limit or terminate testing of one or more of
  our drug candidates. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against product
  liability claims could prevent or inhibit the commercialization of our drug candidates. We currently carry clinical trial insurance
  but do not carry product liability insurance. If we successfully commercialize one or more of our drug candidates, we may face
  product liability claims, regardless of FDA approval for commercial manufacturing and sale. We may not be able to obtain such
  insurance at a reasonable cost, if at all. Even if our agreements with any current or future corporate collaborators entitle us
  to indemnification against product liability losses, such indemnification may not be available or adequate should any claim arise.
  If
  our drug candidates receive regulatory approval, we and our collaborators will also be subject to ongoing FDA obligations and
  continued regulatory review, such as continued safety reporting requirements, and we and our collaborators may also be subject
  to additional FDA post-marketing obligations or new regulations, all of which may result in significant expense and limit our
  and our collaborators' ability to commercialize our drugs.
  Any regulatory
  approvals that our drug candidates receive may also be subject to limitations on the indicated uses for which the drug may be
  marketed or contain requirements for y costly post-marketing follow-up studies. In addition, if the FDA approves any of our drug
  candidates, the labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping for the drug
  will be subject to extensive regulatory requirements. The subsequent discovery of previously unknown problems with the drug, including
  but not limited to adverse events of unanticipated severity or frequency, or the discovery that adverse events previously observed
  in preclinical research or clinical trials that were believed to be minor actually constitute much more serious problems, may
  result in restrictions on the marketing of the drug, and could include withdrawal of the drug from the market.
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  The FDA's
  policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our
  drug candidates. For example, on July 9, 2012, the FDA approved a risk management program, known as a Risk Evaluation and
  Mitigation Strategy, or REMS, for extended-release and long-acting opioid analgesics, or ER/LA opioid analgesics. This REMS will
  require companies affected by the REMS to make available training for health care professionals who prescribe ER/LA opioid analgesics
  on proper prescribing practices and also to distribute educational materials to prescribers and patients on the safe use of ER/LA
  opioid analgesics.
  We cannot
  predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative
  action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we may be subject to fines,
  suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
  Any of these events could prevent us from marketing our drugs and our business could suffer drug candidates and we will not become
  competitive with our drug candidates being developed. If time and resources devoted are limited or there is a failure to fund
  the continued development other opioid drug candidates or there is otherwise a failure to perform as we expect, we may not achieve
  clinical and regulatory milestones and regulatory submissions and related product introductions may be delayed or prevented, and
  revenues that we would receive from these activities will be less than expected.
  We may depend
  on independent investigators and collaborators, such as universities and medical institutions, to conduct our clinical trials
  under agreements with us. These investigators and collaborators are not our employees and we cannot control the amount or timing
  of resources that they devote to our programs. They may not assign as great a priority to our programs or pursue them as diligently
  as we would if we were undertaking such activities ourselves. If these investigators or collaborators fail to devote sufficient
  time and resources to our drug development programs, or if their performance is substandard, the approval of our regulatory submissions
  and our introductions of new drugs will be delayed or prevented.
  Our potential
  collaborators may also have relationships with other commercial entities, some of which may compete with us. If outside collaborators
  assist our competitors to our detriment, the approval of our regulatory submissions will be delayed and the sales from our products,
  if any are commercialized, will be less than expected.
  We
  may not succeed at in-licensing drug candidates or technologies to expand our product pipeline.
  We may not
  successfully in-license drug candidates or technologies to expand our product pipeline. The number of such candidates and technologies
  is limited. Competition among large pharmaceutical companies and biopharmaceutical companies for promising drug candidates and
  technologies is intense because such companies generally desire to expand their product pipelines through in-licensing. If we
  fail to carry out such in-licensing and expand our product pipeline, our potential future revenues may suffer.
  If
  we fail to obtain or maintain necessary U.S. Food and Drug Administration clearances for our pain therapy products, or if such
  clearances are delayed, we will be unable to commercially distribute and market our products.
  Our products
  are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. The process
  of seeking regulatory clearance or approval to market a pain therapy product, in particular a controlled substance is expensive
  and time consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed. If we are
  not successful in obtaining timely clearance or approval of our products from the FDA, we may never be able to generate significant
  revenue and may be forced to cease operations. In particular, the FDA permits commercial distribution of a new pain therapy product
  only after the product has received approval of a New Drug Application ("NDA") filed with the FDA pursuant to 21 C.F.R.
  § 314, seeking permission to market the product in interstate commerce in the United States. The NDA process is costly, lengthy
  and uncertain. Any NDA application filed by the Company will have to be supported by extensive data, including, but not limited
  to, technical, nonclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA's satisfaction the
  safety and efficacy of the product for its intended use.
  Obtaining
  clearances or approvals from the FDA and from the regulatory agencies in other countries could result in unexpected and significant
  costs for us and consume management's time and other resources. The FDA and other agencies could ask us to supplement our
  submissions, collect non-clinical data, conduct additional clinical trials or engage in other time-consuming actions, or they
  could simply deny our applications. In addition, even if we obtain an NDA approval or pre-market approvals in other countries,
  the approval could be revoked or other restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness.
  We cannot predict with certainty how, or when, the FDA will act. If we are unable to obtain the necessary regulatory approvals,
  our financial condition and cash flow may be adversely affected, and our ability to grow domestically and internationally may
  be limited. Additionally, even if cleared or approved, the Company's products may not be approved for the specific indications
  that are most necessary or desirable for successful commercialization or profitability.
  Our
  clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which could prevent or delay
  regulatory approval and commercialization.
  Before obtaining
  regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and
  expensive nonclinical testing and clinical trials that the product is both safe and effective for use in each target indication.
  Clinical trial results from the study of chronic pain (e.g., osteoarthritis and chronic low back pain) and neuropathic pain (e.g.,
  painful diabetic neuropathy, postherpetic neuralgia and painful HIV-associated neuropathy) are inherently difficult to predict.
  The primary measure of pain is subjective and can be influenced by factors outside of our control, and can vary widely from day
  to day for a particular patient, and from patient to patient and site to site within a clinical study. The results we have obtained
  in completed animal studies or we have observed in published clinical trials conducted by third parties of other dosage forms
  of the same drug (e.g., sublingual, immediate release oral, parenteral) may not be predictive of results from our future clinical
  trials. Additionally, we may suffer significant setbacks in advanced clinical trials, even after promising results in earlier
  studies.
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  We
  cannot predict whether regulatory agencies will determine that the data from our clinical trials support marketing approval.
  The FDA's
  and other regulatory agencies' decision to approve our analgesic product candidates will depend on our ability to demonstrate
  with substantial clinical evidence through well-controlled clinical trials, that the product candidates are effective, as measured
  statistically by comparing the overall improvement in pain in actively-treated patients against improvement in pain in the control
  group (usually a placebo control). However, there is a possibility that our data may fail to show a statistically significant
  difference from the placebo-control or the active control. Alternatively, there is a possibility that our data may be statistically
  significant, but that the actual clinical benefit of the product candidates may not be considered to be clinically significant,
  clinically relevant or clinically meaningful. Consequently, we believe that the FDA may consider additional data, such as a "responder"
  analysis, secondary efficacy endpoints and even safety when evaluating whether our product can be approved. We believe that the
  FDA views "responders" as patients who experience at least a 30% reduction in overall pain. We cannot predict whether
  the regulatory agencies will find that our clinical trial results provide compelling "responder" or other secondary
  endpoint data. Even if we believe that the data from our trials will support marketing approval in the United States or in Europe,
  we cannot predict whether the agencies will agree with our analysis and approve our applications.
  We
  may need to focus our future efforts in new therapeutic areas where we have little or no experience.
  Although
  our primary strategic interest is in the area of pain management, a number of our products have potential efficacy in other therapeutic
  areas such as addition. If our drug development efforts in pain management fail, or if the competitive landscape or investment
  climate for analgesic dug development is less attractive, we may need to change the company's strategic focus to include
  development of our product candidates or of newly acquired product candidates for therapeutic areas other than pain. We have very
  limited drug development experience in other therapeutic areas and we may be unsuccessful in making this change from a pain management
  company to a company with a focus in areas other than pain or a company with a focus in multiple therapeutic areas including pain.
  Our
  product candidates contain controlled substances, the supply of which may be limited by U.S. government policy and the use of
  which may generate public controversy.
  The active
  ingredients in our current product candidates, including levorphanol, buprenorphine and d-Methadone are listed by the DEA, as
  "Controlled Substances" or schedule substances, under the Controlled Substances Act of 1970. The DEA regulates chemical
  compounds as Schedule I, II, III, IV or V substances, with Schedule I substances considered to present the highest risk of substance
  abuse and Schedule V substances the lowest risk. These product candidates are subject to DEA regulations relating to manufacturing,
  storage, distribution and physician prescription procedures. For example, all regular Schedule II drug prescriptions must be signed
  by a physician and may not be refilled.
  Some of
  our drug products (e.g., buprenorphine, REL-1041) have a less restrictive controlled substance schedule (i.e., within the Schedule
  III to V range) than Schedule II drugs. According to the DEA, Schedule V drugs have lower abuse potential than Schedule II, III
  and IV drugs, Schedule IV drugs have lower abuse potential than Schedule II and III drugs and Schedule III drugs have lower abuse
  potential than Schedule II. However, despite the foregoing reduced risk of abuse from Schedule III, IV and V drugs, when compared
  to Schedule II drugs, there is no assurance that such reduced risk can be demonstrated in well controlled non-clinical and/or
  clinical studies in models of physical dependence, psychic dependence, addiction or precipitated withdrawal, or in studies of
  addiction or abuse liability in opioid addicts, opioid ex-addicts or recreational drug users. In the event that a reduced risk
  of abuse from Schedule III, IV and V drugs, when compared to Schedule II drugs is demonstrated in well controlled non-clinical
  and/or clinical studies, there is no assurance that the FDA will agree to incorporation of such favorable language in the products
  prescribing information.
  Our LevoCap
  ER is a Schedule II drug in an abuse resistant, abuse deterrent or tamper resistant dosage form. Although the dosage form is referred
  to as abuse resistant, abuse deterrent or tamper resistant, a determined or persistent abuser can defeat, wholly or partially,
  the tamper resistance within the dosage form. In addition, opioid addicts and recreational opioid users can over time find new
  methods to defeat the tamper resistance mechanism within the dosage form.
  Although
  our LevoCap ER is a tamper resistant dosage form, we may elect to not seek specific language in the prescribing information to
  describe this feature in order to reduce the amount of data required for our NDA, the time required to file the NDA and/or the
  probability of a protracted review process. The absence of such language in the prescribing information may reduce the commercial
  value of the product. Even if we do seek specific language in the prescribing information to describe the tamper resistance feature,
  there is no assurance that FDA will agree to any such language.
  Products
  containing controlled substances may generate public controversy. Opponents of these products may seek restrictions on marketing
  and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort
  to persuade the medical community to reject these products. Political pressures and adverse publicity could lead to delays in,
  and increased expenses for, and limit or restrict the introduction and marketing of our product candidates.
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  Table of Contents
  Failure
  to comply with the Drug Enforcement Administration regulations, or the cost of compliance with these regulations, may adversely
  affect our business.
  A number
  of our products are opioids and subject to extensive regulation by the DEA, due to their status as controlled substances or scheduled
  drugs. Although d-Methadone is substantially devoid of opioid activity, the DEA may elect to designate it as a controlled substance
  falling under a Schedule, up to the Schedule II [C-II]. Any level of DEA scheduling for d-Methadone, particularly Schedule II,
  III or IV, would substantially reduce commercial interest in d-Methadone. Additionally, d-Methadone is produced by separation
  from racemic methadone, a scheduled drug subject to extensive regulation by the DEA.
  The manufacture,
  shipment, storage, sale and use of controlled substances are subject to a high degree of regulation, including security, record-keeping
  and reporting obligations enforced by the DEA. For example, all Schedule II drug prescriptions must be signed by a physician,
  physically presented to a pharmacist and may not be refilled. This high degree of regulation can result in significant costs in
  order to comply with the required regulations, which may have an adverse effect on the development and commercialization of our
  product candidates.
  The DEA
  limits the availability and production of all scheduled substances, including our product candidates, through a quota system.
  The DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before assigning quotas
  to manufacturers. In future years, we may need greater amounts of controlled substances to sustain our Phase III development program,
  and we will need significantly greater amounts to implement our commercialization plans if the FDA approves our proposed formulations.
  Any delay or refusal by the DEA in establishing the procurement quota or a reduction in our quota for scheduled controlled substances
  or a failure to increase it over time as we anticipate could delay or stop the clinical development or commercial sale of some
  of our products or product candidates. This could have a material adverse effect on our business, results of operations, financial
  condition and prospects.
  Some
  of our products for clinical trials are manufactured outside the United States including Schedule II controlled substances.
  Drug Enforcement
  Administration regulations require Scheduled II controlled substances to be manufactured in the United States if the products
  are to be marketed in the United States. There is no guarantee that we will secure a commercial supply agreement with a manufacturer
  based in the United States. Switching or adding commercial manufacturing capability can involve substantial cost and require extensive
  management time and focus, as well as additional regulatory filings. In addition, there is a natural transition period when a
  new manufacturing facility commences work. As a result, delays may occur, which can materially impact our ability to meet our
  desired commercial timelines, thereby increasing our costs and reducing our ability to generate revenue.
  The facilities
  of any of our future manufacturers of controlled substances must be approved by the FDA after we submit our NDA and before approval.
  We are dependent on the continued adherence of third party manufacturers to GMP manufacturing and acceptable changes to their
  process. If our manufacturers cannot successfully produce material that conforms to our specifications and the FDA's strict regulatory
  requirements, they will not be able to secure FDA approval for their manufacturing facilities. If the FDA does not approve these
  facilities for the commercial manufacture, we will need to find alternative suppliers, which would result in significant delays
  in obtaining FDA approvals. These challenges may have a material adverse impact on our business, results of operations, financial
  condition and prospects.
  We manufacture
  some products outside the United States for development and to conduct human clinical studies either in the US or outside the
  US. These products are for development purposes only, and not for commercial manufacturing.
  If
  the supplier of active pharmaceutical ingredient (API) or pharmaceutical excipient fails to provide us sufficient quantities,
  we may not be able to obtain an alternative supply on a timely or acceptable basis.
  We currently
  rely on a single source for our supply of levorphanol. There are presently no alternative sources of pharmaceutical grade levorphanol.
  We may also not be able to find alternative suppliers in a timely manner that would provide levorphanol at acceptable quantities
  and prices. Any interruption in the supply of levorphanol would disrupt our ability to manufacture LevoCap ER and could have a
  material adverse effect on our business. Currently this single source supplies the API for research and development purposes only.
  There is no material agreement for commercial supply at this time.
  Our pharmaceutical
  excipients and other API's are multisource, although not all sources have an active Drug Master File (DMF) with the FDA.
  (A DMF is a submission to the FDA used to provide confidential detailed information about facilities, processes, or articles used
  in the manufacturing, processing, packaging, and storing of drugs to support a drug development and approval). In addition, some
  of the countries for our multisource APIs are not the same as our drug manufacturing locations. Thus, any disruption in supply
  from our preferred vendor could result in significant delays with our pharmaceutical development, clinical trials, NDA filing,
  NDA approval or commercial sale of the finished product due to contract delays, the need to manufacture a new batch of API, out
  of specification API, the need for import and export permits, and the failure of the newly sourced API to perform to the standards
  of the previously sourced API.
  Our
  pain product candidates are in the early stages of development and we have not demonstrated that any of our products can actually
  treat pain.
  Adverse
  or inconclusive results from pre-clinical testing or clinical trials of product candidates may substantially delay, or halt entirely,
  any further development of one or more of our products. The projected timetables for continued development of the technologies
  and related product candidates by us may otherwise be subject to delay or suspension.
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  Modifications
  to our products may require new NDA approvals.
  Once a particular
  company product receives FDA approval or clearance, expanded uses or uses in new indications of our products may require additional
  human clinical trials and new regulatory approvals or clearances, including additional IND and NDA submissions and premarket approvals
  before we can begin clinical development, and/or prior to marketing and sales. If the FDA requires new clearances or approvals
  for a particular use or indication, we may be required to conduct additional clinical studies, which would require additional
  expenditures and harm our operating results. If the products are already being used for these new indications, we may also be
  subject to significant enforcement actions.
  Conducting
  clinical trials and obtaining clearances and approvals can be a time consuming process, and delays in obtaining required future
  clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in
  turn would harm our future growth.
  There
  is no guarantee that the FDA will grant NDA approval of our future products and failure to obtain necessary clearances or approvals
  for our future products would adversely affect our ability to grow our business.
  We are currently
  preparing to conduct several Phase I/II clinical trials for our drug candidates and in the future expect to submit NDAs to the
  FDA for approval of these products. The FDA may not approve or clear these products for the indications that are necessary or
  desirable for successful commercialization. Indeed, the FDA may refuse our requests for NDA market approval of new products, new
  intended uses or indications to existing or future products. Failure to receive approval for our new products would have an adverse
  effect on our ability to expand our business.
  We
  have no manufacturing capabilities and depend on other parties for our manufacturing operations. If these manufacturers fail to
  meet our requirements and strict regulatory requirements, our product development and commercialization efforts may be materially
  harmed.
  We currently
  depend on contract manufacturers. We plan to enter into long-term commercial supply agreements for our product candidates. If
  any manufacturer is unable to produce required quantities on a timely basis or at all, our operations would be delayed and our
  business harmed. Our reliance on contract manufacturers exposes us to additional risks, including:
  ●
  failure of our
      future manufacturers to comply with strictly-enforced regulatory requirements;
  ●
  failure to manufacture
      to our specifications, or to deliver sufficient quantities in a timely manner;
  ●
  the possibility
      that we may terminate a contract manufacturer and need to engage a replacement;
  ●
  the possibility
      that our future manufacturers may not be able to manufacture our product candidates and products without infringing the intellectual
      property rights of others;
  ●
  the possibility
      that our future manufacturers may not have adequate intellectual property rights to provide for exclusivity and prevent competition;
      and
  ●
  insufficiency
      of intellectual property rights to any improvements in the manufacturing processes or new manufacturing processes for our
      products.
  Any of these
  factors could result in significant delay or suspension of our clinical trials, regulatory submissions, receipt of required approvals
  or commercialization of our products and harm our business.
  Delays
  in the commencement or completion of pharmaceutical development, manufacturing or clinical efficacy and safety testing could result
  in increased costs to us and delay our ability to generate revenues.
  We do not
  know whether our pharmaceutical development, manufacturing or clinical efficacy and safety testing will begin on time or be completed
  on schedule, if at all. For example, we may encounter delays during the manufacture of pilot scale batches including delays with
  our contract development or manufacturing organization, sourcing satisfactory quantities of active pharmaceutical ingredient,
  narcotic import and export permits, sourcing of excipients, contract disputes with our third party vendors and manufacturers,
  or failure of the product to meet specification. Similar delays may occur a during our GMP manufacture of the product.
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  The commencement
  and completion of clinical trials can be disrupted for a variety of reasons, including difficulties in:
  ●
  recruiting and
      enrolling patients to participate in a clinical trial;
  ●
  obtaining regulatory
      approval to commence a clinical trial;
  ●
  reaching agreement
      on acceptable terms with prospective clinical research organizations and trial sites;
  ●
  manufacturing
      sufficient quantities of a product candidate;
  ●
  investigator fraud,
      including data fabrication by clinical trial personnel;
  ●
  diversion of controlled
      substances by clinical trial personnel; and
  A clinical
  trial may also be suspended or terminated by us, the FDA or other regulatory authorities due to a number of factors, including:
  ●
  failure to conduct
      the clinical trial in accordance with regulatory requirements or in accordance with our clinical protocols;
  ●
  inspection of
      the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical
      hold;
  ●
  unforeseen safety
      issues; or
  ●
  inadequate patient
      enrollment or lack of adequate funding to continue the clinical trial.
  In addition,
  changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes,
  which could impact the cost, timing or successful completion of a clinical trial. If we experience delays in the commencement
  or completion of our clinical trials, the commercial prospects for our product candidates will be harmed, and our ability to generate
  product revenues will be delayed. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
  trials may also lead to the denial of regulatory approval of a product candidate.
  We
  intend to rely on third parties to conduct our clinical trials. If these third parties do not perform as contractually required
  or otherwise expected, we may not be able to obtain regulatory approval for our product candidates.
  At this
  time we do not have any ongoing trials. However, we do not currently intend to conduct clinical trials on our own, and instead
  will rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract
  laboratories, to assist us with our clinical trials. We are also required to comply with regulations and standards, commonly referred
  to as good clinical practices, for conducting, recording and reporting the results of clinical trials to assure that data and
  reported results are credible and accurate and that the trial participants are adequately protected. If these third parties do
  not successfully carry out their duties to us or regulatory obligations or meet expected deadlines, if the third parties need
  to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical
  protocols or regulatory requirements or for other reasons, our nonclinical development activities or clinical trials may be extended,
  delayed, suspended or terminated, and we may not be able to obtain regulatory approval for our product candidates.
  Clinical
  trials necessary to support NDA approval of our future products will be time consuming and expensive. Delays or failures in our
  clinical trials will prevent us from commercializing our products and will adversely affect our business, operating results and
  prospects and could cause us to cease operations.
  Initiating
  and completing clinical trials necessary to support NDA approval of a new formulation of an existing product or a new product,
  will be time consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily
  predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical
  trials.
  Some of
  the trials we undertake are not designed to support final NDA approval of the product and additional trials will have to be conducted
  in the future before we file an NDA. In addition, there can be no assurance that the data generated during the trials will meet
  our chosen safety and effectiveness endpoints or otherwise produce results that will eventually support the filing or approval
  of an NDA.
  Conducting
  successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to
  identify and recruit.
  Patient
  enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size
  of the patient population; the nature of the trial protocol; the attractiveness of, or the discomforts and risks associated with,
  the treatments received by enrolled subjects; the availability of appropriate clinical trial investigators; support staff; and
  proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in
  the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the
  trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness
  of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable
  risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous
  clinical trials of competitive products.
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  Table of Contents
  Development
  of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop
  such protocols to support clearance and approval.
  The FDA
  may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period
  or change the data collection requirements or data analysis applicable to our clinical trials. They may also require additional
  data on certain categories of patients, should it emerge during the conduct of our clinical trials that certain categories of
  patients are likely to be affected in different and/or additional manner than most of the patients. In addition to FDA requirements,
  our clinical trial requires the approval of the institutional review board, or IRB, at each site selected for participation in
  our clinical trial.
  Additional
  delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial,
  if such modifications are warranted and/or required by the occurrences in the given trial
  .
  Each of
  such modifications has to be submitted to the FDA. This could result in the delay or halt of a clinical trial while the modification
  is evaluated. In addition, depending on the magnitude and nature of the changes made, FDA could take the position that the data
  generated by the clinical trial cannot be pooled because the same protocol was not used throughout the trial. This might require
  the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying clearance
  or approval of a product.
  There
  can be no assurance that the data generated using modified protocols will be acceptable to FDA.
  There can
  be no assurance that the data generated using modified protocols will be acceptable to FDA or that if future modifications during
  the trial are necessary, any such modifications will be acceptable to FDA. If FDA believes that its prior approval is required
  for a particular modification, it can delay or halt a clinical trial while it evaluates additional information regarding the change.
  Serious
  injury or death resulting from a failure of one of our drug candidates during current or future clinical trials could also result
  in the FDA delaying our clinical trials or denying or delaying clearance or approval of a product.
  Even though
  an adverse event may not be the result of the failure of our drug candidate, FDA or an IRB could delay or halt a clinical trial
  for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such events.
  Any delay
  or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining
  or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate
  in a clinical trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during
  the trials, may cause an increase in costs and delays in the filing of any product submissions with the FDA, delay the approval
  and commercialization of our products or result in the failure of the clinical trial, which could adversely affect our business,
  operating results and prospects. Lengthy delays in the completion of clinical trials of our products would adversely affect our
  business and prospects and could cause us to cease operations.
  On November
  29, 2006 the FDA imposed a bold warning on the label of racemic methadone, a parent compound to our d-Methadone related to cardiac
  death. Although the decision was based on case reports and not on a controlled clinical trial, as part of the development of d-Methadone
  we will likely have to conduct a specific study to evaluate the effects of d-Methadone on QTc interval prolongation. QT interval
  is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. Drugs
  that prolong the corrected QT interval (QTc) interval are associated with an increased risk of serious disturbances in heart rhythm,
  leading to sudden death. QT interval studies can be extremely costly and there is no assurance that we will have funds to undertake
  such a study. In addition, even if we do a QT interval prolongation study in accordance with regulatory guidelines, there is no
  assurance that the results of the study will demonstrate an absence of QT interval prolongation with d-Methadone. An adverse safety
  outcome from such study could result in a similar bolded warning on the label of d-Methadone or in a decision not to approve d-Methadone,
  either one of which could have serious consequences for our continued operation.
  If
  the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform
  as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.
  We do not
  have the ability to independently conduct all the pre-clinical and clinical trials for our products and we must rely on third
  parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct
  such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected
  deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due
  to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development
  activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval
  for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects
  may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical
  trials for reasons outside of their control.
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  The
  future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery
  of unexpected adverse side effects.
  Even if
  our clinical trials are completed as planned, we cannot be certain that their results will support our drug candidate claims or
  that the FDA or foreign authorities will agree with our conclusions regarding them. Success in pre-clinical studies and early
  clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will
  replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our drug
  candidates are safe and effective for the proposed indicated uses. If FDA concludes that the clinical trials for any of our products
  for which we might seek clearance, have failed to demonstrate safety and effectiveness, we would not receive FDA clearance to
  market that product in the United States for the indications sought. In addition, such an outcome could cause us to abandon the
  product candidate and might delay development of others. Any delay or termination of our clinical trials will delay the filing
  of any product submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.
  It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part
  of the product candidate's profile. In addition, our clinical trials performed until now involve a relatively small patient
  population. Because of the small sample size, their results may not be indicative of future results.
  Future
  products may never achieve market acceptance.
  Future products
  that we may develop may never gain market acceptance among physicians, patients and the medical community. The degree of market
  acceptance of any of our products will depend on a number of factors, including the actual and perceived effectiveness and reliability
  of our products; the results of any long−term clinical trials relating to use of our products; the availability, relative
  cost and perceived advantages and disadvantages of alternative technologies; the degree to which treatments using our products
  are approved for reimbursement by public and private insurers; the strength of our marketing and distribution infrastructure;
  and the level of education and awareness among physicians and hospitals concerning our products. Failure of any of our products
  to significantly penetrate current or new markets would negatively impact our business, financial condition and results of operations.
  To
  be commercially successful, physicians must be persuaded that using our products for treatment of pain are effective alternatives
  to existing therapies and treatments.
  We believe
  that pain doctors and other physicians will not widely adopt our products unless they determine, based on experience, clinical
  data, and published peer reviewed journal articles, that the use of our products provides an effective alternative to other means
  of treating pain. Patient studies or clinical experience may indicate that treatment with our products does not provide patients
  with sufficient benefits in pain intensity and/or quality of life. We believe that recommendations and support for the use of
  our products from influential physicians will be essential for widespread market acceptance. Our products are still in the development
  stage and it is premature to attempt to gain support from physicians at this time. We can provide no assurance that such support
  will ever be obtained. If our products do not receive such support from these physicians and from long-term data, physicians may
  not use or continue to use, and hospitals may not purchase or continue to purchase, our products.
  Even
  if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulation or if
  we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the
  market.
  Any product
  for which we obtain clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical data
  and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections
  by the FDA. In particular, we and our suppliers are required to comply with FDA's Quality System Regulations, or QSR, and
  International Standards Organization, or ISO, regulations for the manufacture of our products and other regulations which cover
  the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and
  shipping of any product for which we obtain clearance or approval. Regulatory bodies, such as the FDA, enforce these regulations
  through periodic inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered
  by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations
  or product safety issues could result in, among other things, enforcement actions by the FDA.
  If any of
  these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent
  us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance
  with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in
  the required quantities, if at all.
  Even if
  regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended
  uses for which the product may be marketed and reduce the potential to successfully commercialize the product and generate revenue
  from the product. If the FDA determines that the product promotional materials, labeling, training or other marketing or educational
  activities constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify
  our training or promotional materials or subject us to regulatory enforcement actions. It is also possible that other federal,
  state or foreign enforcement authorities might take action if they consider such training or other promotional materials to constitute
  promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as
  laws prohibiting false claims for reimbursement.
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  In addition,
  we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products,
  and we must comply with adverse event and pharmacovigilance reporting requirements, including the reporting of adverse events
  which occur in connection with, and whether or not directly related to, our products. Later discovery of previously unknown problems
  with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing
  problems, or failure to comply with regulatory requirements, may result in changes to labeling, restrictions on such products
  or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to recall,
  replace or refund the cost of any product we manufacture or distribute, fines, suspension of regulatory approvals, product seizures,
  injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and
  prospects.
  Some
  of our other product candidates will require Risk Evaluation and Mitigation Strategies (REMS).
  The FDA
  Amendments Act of 2007 implemented safety-related changes to product labeling and requires the adoption of REMS. Some of our product
  candidates, the controlled substance-based and maybe others, will require REMS. The REMS may include requirements for special
  labeling or medication guides for patients, special communication plans to health care professionals and restrictions on distribution
  and use. We cannot predict the specific REMS to be required as part of the FDA's approval of any of our products. Depending on
  the extent of the REMS requirements, our costs to commercialize our products may increase significantly. Furthermore, controlled
  substances risks that are not adequately addressed through proposed REMS for our product candidates may also prevent or delay
  their approval for commercialization.
  Our
  revenue stream will depend upon third party reimbursement.
  The commercial
  success of our products in both domestic and international markets will be substantially dependent on whether third-party coverage
  and reimbursement is available for patients that use our products. However, the availability of insurance coverage and reimbursement
  for newly approved drugs to treat pain is uncertain, and therefore, third-party coverage may be particularly difficult to obtain
  even if our products are approved by the FDA as safe and efficacious. Many patients using existing approved therapies are generally
  reimbursed all or part of the product cost by Medicare or other third-party payors. Medicare, Medicaid, health maintenance organizations
  and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of
  reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for these products. Submission of
  applications for reimbursement approval generally does not occur prior to the filing of an NDA for that product and may not be
  granted for as long as many months after NDA approval. In order to obtain reimbursement arrangements for these products, we or
  our commercialization partners may have to agree to a net sales price lower than the net sales price we might charge in other
  sales channels. The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare may limit
  our revenue. Initial dependence on the commercial success of our products may make our revenues particularly susceptible to any
  cost containment or reduction efforts.
  We
  are dependent on third parties for manufacturing and marketing of our proposed proprietary products. If we are not able to secure
  favorable arrangements with such third parties, our business and financial condition could be harmed.
  We are not
  planning to manufacture any of our proposed proprietary products for commercial sale nor do we have the resources necessary to
  do so. In addition, we currently do not have the capability to market our drug products ourselves. We intend to contract with
  specialized manufacturing companies to manufacture our proposed proprietary products and partner with larger pharmaceutical companies
  for commercialization of our products, retaining the marketing and promotion rights for specialty medical areas. In connection
  with our efforts to commercialize our proposed proprietary products, we will seek to secure favorable arrangements with third
  parties to distribute, promote, market and sell our proposed proprietary products. If we are not able to secure favorable commercial
  terms or arrangements with third parties for distribution, marketing, promotion and sales of our proposed proprietary products,
  we may have to retain promotional and marketing rights and seek to develop the commercial resources necessary to promote or co-promote
  or co-market certain or all of our proprietary drug candidates to the appropriate channels of distribution in order to reach the
  specific medical market that we are targeting. We may not be able to enter into any partnering arrangements on this or any other
  basis. If we are not able to secure favorable partnering arrangements, or are unable to develop the appropriate resources necessary
  for the commercialization of our proposed proprietary products, our business and financial condition could be harmed. In addition,
  we will have to hire additional employees or consultants, since our current employees have limited experience in these areas.
  Sufficient employees with relevant skills may not be available to us. Any increase in the number of our employees would increase
  our expense level, and could have an adverse effect on our financial position.
  In addition,
  we, or our potential commercial partners, may not successfully introduce our proposed proprietary products or our proposed proprietary
  products may not achieve acceptance by patients, health care providers and insurance companies. Further, it is possible that we
  may not be able to secure arrangements to manufacture, market, distribute, promote and sell our proposed proprietary products
  on favorable commercial terms that would permit us to make a profit. To the extent that corporate partners conduct clinical trials,
  we may not be able to control the design and conduct of these clinical trials.
  We
  must enter into an agreement with, and depend upon, one or more partners to assist us in commercializing our product candidates.
  Because
  of our limited financial and other resources, we must actively seek and enter into a collaboration with one or more partners to
  assist us in our product launch, if marketing approval is granted. Any collaboration agreement we enter into may contain unfavorable
  terms, for example, with respect to product candidates covered, control over decisions and responsibilities, termination rights,
  payment, and other significant terms. Our ability to receive any significant revenue from our product candidates covered by the
  collaboration agreement will be dependent on the efforts of our collaboration partner and may result in lower levels of income
  to us than if we marketed our product candidates entirely on our own. The collaboration partner may not fulfill its obligations
  or commercialize our product candidates as quickly as we would like. We could also become involved in disputes with our partner,
  which could lead to delays in or termination of our commercialization programs and time-consuming and expensive litigation or
  arbitration. If a collaboration partner terminates or breaches its agreement with us, or otherwise fails to complete its obligations
  in a timely manner, the chances of successfully developing or commercializing our product candidates would be materially and adversely
  affected.
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  Additionally,
  depending upon the collaboration partner that we choose, other companies that might otherwise be interested in developing products
  with us could be less inclined to do so because of our relationship with the collaboration partner. If our ability to work with
  present or future strategic partners or collaborators is adversely affected as a result of our collaboration agreement, our business
  prospects may be limited and our financial condition may be adversely affected.
  We
  may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.
  We may have
  conflicts with our partners, such as conflicts concerning the interpretation of nonclinical or clinical data, the achievement
  of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership
  of intellectual property developed during our collaboration. If any conflicts arise with any of our partners, such partner may
  act in a manner that is adverse to our best interests. Any such disagreement could result in one or more of the following, each
  of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating
  revenues: unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;
  uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent
  us from entering into additional collaborations; unwillingness by the partner to cooperate in the development or manufacture of
  the product, including providing us with product data or materials; unwillingness on the part of a partner to keep us informed
  regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those
  activities; initiating of litigation or alternative dispute resolution options by either party to resolve the dispute; or attempts
  by either party to terminate the agreement.
  We
  have no experience selling, marketing or distributing products and no internal capability to do so.
  We currently
  have no sales, marketing or distribution capabilities. In order to commercialize our products, if any are approved, we intend
  to develop internal sales, marketing and distribution capabilities to target particular markets for our products, as well as make
  arrangements with third parties to perform these services for us with respect to other markets for our products. We may not be
  able to establish these capabilities internally or hire marketing and sales personnel with appropriate expertise to market and
  sell our products, if approved. In addition, even if we are able to identify one or more acceptable collaborators to perform these
  services for us, we may not be able to enter into any collaborative arrangements on favorable terms, or at all. If we enter into
  any collaborative arrangements for the marketing or sale of our products, our product revenues are likely to be lower than if
  we marketed and sold our products ourselves. In addition, any revenues we receive would depend upon the efforts of our collaborators,
  which may not be adequate due to lack of attention or resource commitments, management turnover, change of strategic focus, business
  combinations, and their inability to comply with regulatory requirements or other factors outside of our control. Depending upon
  the terms of our collaboration, the remedies we have against an under-performing collaborator may be limited. If we were to terminate
  a relationship, it may be difficult or impossible to find a replacement collaborator on acceptable terms, if at all.
  Upon
  commercialization of our products, we may be dependent on third parties to market, distribute and sell our products.
  Our ability
  to receive revenues may be dependent upon the sales and marketing efforts of any future co-marketing partners and third-party
  distributors. At this time, we have not entered into an agreement with any commercialization partner and only plan to do so after
  the successful completion of Phase II clinical trials and prior to commercialization. If we fail to reach an agreement with any
  commercialization partner or upon reaching such an agreement that partner fails to sell a large volume of our products, it may
  have a negative impact on our business, financial condition and results of operations.
  Our
  products will face significant competition in the markets for such products, and if they are unable to compete successfully, our
  business will suffer.
  Our products
  candidates face, and will continue to face, intense competition from large pharmaceutical companies, specialty pharmaceutical
  and biotechnology companies as well as academic and research institutions. We compete in an industry that is characterized by:
  (i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition and (iv) new product introductions.
  Our competitors have existing products and technologies that will compete with our products and technologies and may develop and
  commercialize additional products and technologies that will compete with our products and technologies. Because several competing
  companies and institutions have greater financial resources than us, they may be able to: (i) provide broader services and product
  lines, (ii) make greater investments in research and development, (R&D
  )
  , and (iii) carry on larger R&D initiatives.
  Our competitors also have greater development capabilities than we do and have substantially greater experience in undertaking
  nonclinical and clinical testing of products, obtaining regulatory approvals, and manufacturing and marketing pharmaceutical products.
  They also have greater name recognition and better access to customers than us. Our chief competitors include companies such as
  Purdue Pharma, Pfizer, Eli Lilly, Endo, Astra Zeneca, among others.
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  We
  are faced with intense competition and rapid technological change, which may make it more difficult for us to achieve significant
  market penetration. If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient
  product revenues and our business will suffer.
  The market
  for our product candidates is characterized by intense competition and rapid technological advances. If our product candidates
  receive FDA approval, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed
  by others. If our competitors' existing products or new products are more effective than or considered superior to our future
  products, the commercial opportunity for our product candidates will be reduced or eliminated. Existing or future competing products
  may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may
  offer comparable performance at a lower cost. We face competition from fully integrated pharmaceutical companies and smaller companies
  that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private
  research organizations. If we are successful in penetrating the market for pain treatment with our product candidates, other companies
  may be attracted to the market. Many of our competitors have analgesics already approved or in development. In addition, many
  of these competitors, either alone or together with their collaborative partners, are larger than we are and have substantially
  greater financial, technical, research, marketing, sales, distribution and other resources than we do. Our competitors may develop
  or market products that are more effective or commercially attractive than any that we are developing or marketing. Our competitors
  may obtain regulatory approvals, and introduce and commercialize products before we do. These developments could have a significant
  negative effect on our financial condition. Even if we are able to compete successfully, we may not be able to do so in a profitable
  manner.
  Adverse
  events involving our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could
  harm our reputation, business and financial results.
  Once a product
  receives FDA clearance or approval, the agency has the authority to require the recall of commercialized products in the event
  of adverse side effects, material deficiencies or defects in design or manufacture. The authority to require a recall must be
  based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death. Manufacturers
  may, under their own initiative, recall a product if any material deficiency in a product is found. A government-mandated or voluntary
  recall by us or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination,
  manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert
  managerial and financial resources and have an adverse effect on our financial condition and results of operations. The FDA requires
  that certain classifications of recalls be reported to FDA within 10 working days after the recall is initiated. Companies are
  required to maintain certain records of recalls, even if they are not reportable to the FDA. We may initiate voluntary recalls
  involving our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our determinations,
  they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers
  and negatively affect our sales. In addition, the FDA could take enforcement action for failing to report the recalls when they
  were conducted.
  We
  may be exposed to liability claims associated with the use of hazardous materials and chemicals.
  Our research
  and development activities involve the controlled use of hazardous materials and chemicals. Although we believe that our safety
  procedures for using, storing, handling and disposing of these materials comply with federal, state and local laws and regulations,
  we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident,
  we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial
  condition and results of operations. In addition, the federal, state and local laws and regulations governing the use, manufacture,
  storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance
  costs that could materially adversely affect our business and financial condition.
  We
  may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability
  lawsuits.
  The testing
  and marketing of medical products entail an inherent risk of product liability. We may be held liable if serious adverse reactions
  from the use of our product candidates occur. If we cannot successfully defend ourselves against product liability claims, we
  may incur substantial liabilities or be required to limit commercialization of our product candidates. Our inability to obtain
  sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent
  or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators. We currently do
  not carry product liability insurance. We, or any corporate collaborators, may not be able to obtain insurance at a reasonable
  cost, if at all. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses,
  such indemnification may not be available or adequate if any claim arises.
  Our
  business depends upon securing and protecting critical intellectual property.
  Our commercial
  success will depend in part on our obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies
  in the United States and other jurisdictions as well as successfully enforcing this intellectual property and defending this intellectual
  property against third-party challenges. We will only be able to protect our technologies from unauthorized use by third parties
  to the extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them. In particular,
  we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and
  processes. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only
  limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. Moreover,
  the degree of future protection of our proprietary rights is uncertain for products that are currently in the early stages of
  development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial
  versions of these products will incorporate proprietary technologies.
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  Our
  patent position is highly uncertain and involves complex legal and factual questions.
  Accordingly,
  we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. For example,
  we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and
  issued patents; we or our licensors might not have been the first to file patent applications for these inventions; others may
  independently develop similar or alternative technologies or duplicate any of our technologies; it is possible that none of our
  pending patent applications or the pending patent applications of our licensors will result in issued patents; our issued patents
  and issued patents of our licensors may not provide a basis for commercially viable technologies, or may not provide us with any
  competitive advantages, or may be challenged and invalidated by third parties; and, we may not develop additional proprietary
  technologies that are patentable.
  As a result,
  our owned and licensed patents may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret
  protection for the full commercial extent of our technology. The extent to which we are unable to do so could materially harm
  our business.
  We or our
  licensors have applied for and will continue to apply for patents for certain products. Such applications may not result in the
  issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from competition.
  Furthermore, it is possible that patents issued or licensed to us may be challenged successfully. In that event, if we have a
  preferred competitive position because of such patents, any preferred position held by us would be lost. If we are unable to secure
  or to continue to maintain a preferred position, we could become subject to competition from the sale of generic products. Failure
  to receive, inability to protect, or expiration of our patents would adversely affect our business and operations.
  Patents
  issued or licensed to us may be infringed by the products or processes of others. The cost of enforcing our patent rights against
  infringers, if such enforcement is required, could be significant, and the Company does not currently have the financial resources
  to fund such litigation. Further, such litigation can go on for years and the time demands could interfere with our normal operations.
  There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical
  industry. We may become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved
  in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation more effectively
  than we can because of their substantially greater financial resources. Litigation may also absorb significant management time.
  Unpatented
  trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and
  commercial success. Although we attempt to and will continue to attempt to protect our proprietary information through reliance
  on trade secret laws and the use of confidentiality agreements with our corporate partners, collaborators, employees and consultants
  and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any
  event, others may develop independently, or obtain access to, the same or similar information.
  Certain
  of our patent rights are licensed to us by third parties. If we fail to comply with the terms of these license agreements, our
  rights to those patents may be terminated, and we will be unable to conduct our business.
  The
  following is a summary of our patents and patent applications:
  Levorphanol
  :
  These patent applications cover the Levorphanol product.
  Patent application
  12/223.327 filed 1/29/07, Abuse Resistant and Extended Release Formulations and Method of Use Thereof. Currently pending.
  Patent application
  12/597,702 filed 4/28/08, Multimodal Abuse Resistant and Extended Release Opioid Formulations. Currently claims are allowed. Issued
  fee paid.
  Patent application
  13/320,9889 filed 2/26/10, Extended Release Oral Pharmaceutical Compositions of 3-Hydroxy-N-Methylmorphinan and Method of Use.
  Currently pending.
  d-Methadone
  :
  These patent and patent application cover the d-Methadone product.
  Patent No.
  6,008,258 filed 1/21/98, d-Methadone, a Nonopioid Analgesic, Patent granted.
  Patent application
  13/803,375 filed 3/14/13, d-Methadone for the Treatment of Psychiatric Symptoms. Currently pending.
  Buprenorphine
  :
  This patent application covers the buprenorphine product.
  Patent application
  12/988,209 filed 3/9/09, Oral Pharmaceutical Compositions of Buprenorphine and Method of Use. Currently pending.
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  Mepivacaine
  :
  This patent application covers the Mepivacaine product.
  Patent application
  PCT/US2011/032,381 filed 4/13/11, Dermal Pharmaceutical Composition of 1-Methyl-2',6'
  -Pipecoloxylidide
  and Method of Use. Currently pending.
  If
  we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development
  efforts, obtain a license to continue the development or sale of our products, and/or pay damages.
  Our manufacturing
  processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities
  or others, or the trade secrets of those persons and entities. As the pharmaceutical industry expands and more patents are issued,
  the risk increases that our processes and potential products may give rise to claims that they infringe the patents or trade secrets
  of others. These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing
  and marketing of the affected product or process. If any of these actions are successful, in addition to any potential liability
  for damages, we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the
  affected product or use the affected process. Required licenses may not be available on acceptable terms, if at all, and the results
  of litigation are uncertain. If we become involved in litigation or other proceedings, it could consume a substantial portion
  of our financial resources and the efforts of our personnel.
  Our
  ability to protect and enforce our patents does not guaranty that we will secure the right to commercialize our patents.
  A patent
  is a limited monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing of
  a new and non-obvious invention. This monopoly is of limited duration but, while in force, allows the patent holder to prevent
  others from making and/or using his invention. While a patent gives the holder this right to exclude others, it is not a license
  to commercialize the invention, where other permissions may be required for permissible commercialization to occur. For example,
  a drug cannot be marketed without the appropriate authorization from the FDA, regardless of the existence of a patent covering
  the product. Further, the invention, even if patented itself, cannot be commercialized if it infringes the valid patent rights
  of another party.
  We
  rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties,
  our trade secrets may become known to our competitors.
  We rely
  on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties. If these agreements
  are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. We may not have any
  remedies against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate
  us for the damaging disclosure. In addition, we may have to expend resources to protect our interests from possible infringement
  by others.
  If we are
  unable to obtain the statutory patent extension related to the review time in the United States, we may need to rely on the 3-year
  Hatch-Waxman Act marketing exclusivity, the six month pediatric exclusivity, any approved 7- year Orphan Drug exclusivities, potential
  future formulation patents and up to ten years of data exclusivity in Europe.
  We
  may not be able to obtain or maintain orphan drug exclusivity for our products.
  The FDA
  Office of Orphan Products (OOPD) has granted orphan drug designation for mepivacaine to which we have secured rights. The orphan
  designations cover postherpetic neuralgia and painful HIV neuropathy. If a product that has orphan drug designation subsequently
  receives FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, i.e.,
  for seven years, the FDA may not approve any other applications to market the same drug for the same indication, except in very
  limited circumstances. We may be unable to obtain orphan drug designations for any additional mepivacaine product candidates or
  orphan exclusivity for any of our product candidates, or our potential competitors may obtain orphan drug exclusivity for mepivacaine-based
  products competitive with our product candidates before we do, in which case we may be excluded from that market for the exclusivity
  period. Even if we obtain orphan drug exclusivity for any of our product candidates, we may not be able to maintain it if a competitive
  product is shown to be clinically superior to our product. Although obtaining FDA approval to market a product with orphan exclusivity
  can be advantageous, there can be no assurance that it would provide us with a significant commercial advantage.
  We
  may not be able to obtain Hatch-Waxman Act marketing exclusivity or equivalent regulatory data exclusivity protection in other
  jurisdictions for our products.
  We intend
  to rely, in part, on Hatch-Waxman exclusivity for the commercialization of our products in the United States. The Hatch-Waxman
  Act provides marketing exclusivity to the first applicant to gain approval of an NDA under specific provisions of the Food, Drug
  and Cosmetic Act for a product using an active ingredient that the FDA has not previously approved (five years) or for a new dosage
  form, route or indication (three years). This market exclusivity will not prevent the FDA from approving a competitor's
  NDA if the competitor's NDA is based on studies it has performed and not on our studies.
  There can
  be no assurance that European authorities will grant data exclusivity for our products, because it does not contain a new active
  molecule. Even if European data exclusivity is granted for our products, that may not protect us from direct competition. Given
  the well-established use of our product candidates as pain relievers, a competitor with a generic version of our products may
  be able to obtain approval of their product during our product's period of data exclusivity, by submitting a marketing authorization
  application (MAA) with a less than full package of nonclinical and clinical data.
  27
  Table of Contents
  We
  may undertake international operations, which will subject us to risks inherent with operations outside of the United States.
  Although
  we do not have any foreign operations at this time, we intend to seek to obtain market clearances in foreign markets that we deem
  to generate significant opportunities. However, even with the cooperating of a commercialization partner, conducting drug development
  in foreign countries involves inherent risks, including, but not limited to: difficulties in staffing, funding and managing foreign
  operations; unexpected changes in regulatory requirements; export restrictions; tariffs and other trade barriers; difficulties
  in protecting, acquiring, enforcing and litigating intellectual property rights; fluctuations in currency exchange rates; and
  potentially adverse tax consequences.
  If we were
  to experience any of the difficulties listed above, or any other difficulties, any international development activities and our
  overall financial condition may suffer and cause us to reduce or discontinue our international development and registration efforts.
  We
  may not be successful in hiring and retaining key employees.
  Our future
  operations and successes depend in large part upon the continued service of key members of our senior management team whom we
  are highly dependent upon to manage our business, specifically Dr. Traversa, our CEO. If he terminates his employment with
  us, such a departure would have a material adverse effect on our business.
  Our future
  success also depends on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial,
  technical, clinical and regulatory personnel. We will need to hire additional qualified personnel with expertise in nonclinical
  pharmacology and toxicology, pharmaceutical development, clinical research, regulatory affairs, manufacturing, sales and marketing.
  We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions.
  Competition for such individuals, particularly in the United States, is intense, and we may not be able to hire sufficient personnel
  to support our efforts. There can be no assurance that these professionals will be available in the market, or that we will be
  able to retain existing professionals or to meet or to continue to meet their compensation requirements. Furthermore, the cost
  base in relation to such compensation, which may include equity compensation, may increase significantly, which could have a material
  adverse effect on us. Failure to establish and maintain an effective management team and work force could adversely affect our
  ability to operate, grow and manage our business.
  Our
  employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  We
  are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to:
  ●
  comply with FDA
      regulations or similar regulations of comparable foreign regulatory authorities; provide accurate information to the FDA or
      comparable foreign regulatory authorities;
  ●
  comply with federal
      and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by comparable
      foreign regulatory authorities;
  ●
  report financial
      information or data accurately; or
  ●
  disclose unauthorized
      activities to us.
  In particular,
  sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to
  prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide
  range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
  Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could
  result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Ethics, but it is not always possible
  to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective
  in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits
  stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and
  we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business
  and results of operations, including the imposition of significant fines or other sanctions.
  28
  Table of Contents
  Our
  relationships with customers and payors will be subject to applicable anti-kickback, fraud and abuse, transparency, and other
  healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational
  harm, administrative burdens, and diminished profits and future earnings.
  Healthcare
  providers, physicians and payors play a primary role in the recommendation and prescription of any product candidates for which
  we may obtain marketing approval. Our arrangements with payors and customers may expose us to broadly applicable fraud and abuse
  and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through
  which we market, sell and distribute any product candidates for which we may obtain marketing approval. Restrictions under applicable
  federal, state and foreign healthcare laws and regulations may affect our ability to operate, including:
  ●
  the federal Anti-Kickback
      Statute, which prohibits, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration,
      directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase,
      order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs
      such as Medicare and Medicaid;
  ●
  the federal False
      Claims Act, which imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against
      individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment
      that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal
      government;
  ●
  state and foreign
      anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items
      or services reimbursed by non-governmental payors, including private insurers;
  ●
  the federal Health
      Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a
      scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
  ●
  HIPAA, as amended
      by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, which
      also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well
      as their business associates that perform certain services involving the use or disclosure of individually identifiable health
      information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
      individually identifiable health information;
  ●
  laws which require
      pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance
      guidance promulgated by the federal government or otherwise restricting payments that may be made to healthcare providers;
      and
  ●
  federal laws requiring
      drug manufacturers to report information related to payments and other transfers of value made to physicians and other healthcare
      providers, as well as ownership or investment interests held by physicians and their immediate family members, including under
      the federal Open Payments program, as well as other state and foreign laws regulating marketing activities.
  Managing
  our growth as we expand operations may strain our resources.
  We expect
  to need to grow rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our
  drug candidates, which will place a significant strain on our financial, managerial and operational resources. In order to achieve
  and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities. Moreover,
  we will need to increase staffing and to train, motivate and manage our employees. All of these activities will increase our expenses
  and may require us to raise additional capital sooner than expected. Failure to manage growth effectively could harm our business,
  financial condition or results of operations.
  We
  may not successfully manage our growth.
  Our success
  will depend upon the expansion of our operations and the effective management of our growth. We expect to experience significant
  growth in the scope of our operations and the number of our employees. If we grow significantly, such growth will place a significant
  strain on our management and on our administrative, operational and financial resources. To manage this growth, we must expand
  our facilities, augment our operational, financial and management systems, internal controls and infrastructure and hire and train
  additional qualified personnel. Our future success is heavily dependent upon growth and acceptance of our future products. If
  we are unable to scale our business appropriately or otherwise adapt to anticipated growth and new product introduction, our business
  and financial condition will be harmed.
  We
  may expand our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial
  condition and may also dilute current stockholders' ownership interests in our company.
  Our business
  strategy includes expanding our products and capabilities, and we may seek acquisitions of drug candidates or technologies to
  do so. Acquisitions involve numerous risks, including substantial cash expenditures; potentially dilutive issuance of equity securities;
  incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;
  difficulties in assimilating the acquired technologies or the operations of the acquired companies; diverting our management's
  attention away from other business concerns; risks of entering markets in which we have limited or no direct experience; and the
  potential loss of our key employees or key employees of the acquired companies.
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  Table of Contents
  We cannot
  assure you that any acquisition will result in short-term or long-term benefits to us. We may incorrectly judge the value or worth
  of an acquired product, company or business. In addition, our future success would depend in part on our ability to manage the
  rapid growth associated with some of these acquisitions. We cannot assure you that we will be able to make the combination of
  our business with that of acquired products, businesses or companies work or be successful. Furthermore, the development or expansion
  of our business or any acquired products, business or companies may require a substantial capital investment by us. We may not
  have these necessary funds or they might not be available to us on acceptable terms or at all. We may also seek to raise funds
  by selling shares of our preferred or common stock, which could dilute each current stockholder's ownership interest in
  the Company.
  We
  are unable to develop our own sales, marketing and distribution capabilities, or if we are not successful in contracting with
  third parties for these services on favorable terms, or at all, our product revenues could be disappointing
  .
  We currently
  have no sales, marketing or distribution capabilities. In order to commercialize our products, if any are approved by the FDA,
  we will either have to develop such capabilities internally or collaborate with third parties who can perform these services for
  us. If we decide to commercialize any of our drugs ourselves, we may not be able to hire the necessary experienced personnel and
  build sales, marketing and distribution operations which are capable of successfully launching new drugs and generating sufficient
  product revenues. In addition, establishing such operations will take time and involve significant expense.
  If we decide
  to enter into new co-promotion or other licensing arrangements with third parties, we may be unable to locate acceptable collaborators
  because the number of potential collaborators is limited and because of competition from others for similar alliances with potential
  collaborators. Even if we are able to identify one or more acceptable new collaborators, we may not be able to enter into any
  collaborative arrangements on favorable terms, or at all.
  In addition,
  any revenues we receive would depend upon our collaborators' efforts which may not be adequate due to lack of attention
  or resource commitments, management turnover, change of strategic focus, business combinations or other factors outside of our
  control. Depending upon the terms of our collaboration, the remedies we have against an under-performing collaborator may be limited.
  If we were to terminate the relationship, it may be difficult or impossible to find a replacement collaborator on acceptable terms,
  or at all.
  If
  we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and
  our business will suffer.
  The market
  for our drug candidates is characterized by intense competition and rapid technological advances. If our drug candidates receive
  FDA approval, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed
  by others. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for
  a specific indication than our products, or may offer comparable performance at a lower cost. If our products are unable to capture
  and maintain market share, we may not achieve sufficient product revenues and our business will suffer.
  We and our
  collaborators will compete for market share against fully integrated pharmaceutical companies or other companies that are collaborating
  with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations.
  Many of these competitors have drugs already approved or drug candidates in development that will or may compete against our approved
  drug candidates. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger
  research and development programs and have substantially greater financial resources than we do, as well as significantly greater
  experience in:
  ●
  developing drugs;
  ●
  conducting preclinical
      testing and human clinical trials;
  ●
  obtaining FDA
      and other regulatory approvals of drugs;
  ●
  formulating and
      manufacturing drugs; and
  ●
  launching, marketing,
      distributing and selling drugs.
  30
  Table of Contents
  Government
  agencies, professional and medical societies, and other groups may establish usage guidelines that apply to our
  Law enforcement
  concerns over diversion of opioids and social issues around abuse of opioids may make the regulatory approval process and commercialization
  of our drug candidates very difficult.
  Media stories
  regarding the diversion of opioids and other controlled substances are commonplace. Law enforcement agencies or regulatory agencies
  may apply policies that seek to limit the availability of opioids. Such efforts may adversely affect the regulatory approval and
  commercialization of our drug candidates.
  Developments
  by competitors may render our products or technologies obsolete or non-competitive.
  Alternative
  technologies and products are being developed to improve or replace the use of opioids for pain management, several of which are
  in clinical trials or are awaiting approval from the FDA. In addition, the active ingredients in nearly all opioid drugs are available
  in generic form. Drug companies that sell generic opioid drugs represent substantial competition. Many of these organizations
  competing with us have substantially greater capital resources, larger research and development staffs and facilities, greater
  experience in drug development and in obtaining regulatory approvals and greater manufacturing and marketing capabilities than
  we do. Our competitors may market less expensive or more effective drugs that would compete with our drug candidates or reach
  market with competing drugs before we are able to reach market with our drug candidates. These organizations also compete with
  us to attract qualified personnel and partners for acquisitions, joint ventures or other collaborations.
  Business
  interruptions could limit our ability to operate our business.
  Our operations
  as well as those of our collaborators on which we depend are vulnerable to damage or interruption from computer viruses, human
  error, natural disasters, electrical and telecommunication failures, international acts of terror and similar events. We have
  not established a formal disaster recovery plan and our back-up operations and our business interruption insurance may not be
  adequate to compensate us for losses we may suffer. A significant business interruption could result in losses or damages incurred
  by us and require us to cease or curtail our operations.
  Unfavorable
  media coverage of opioid pharmaceuticals could negatively affect our business.
  Opioid drug
  abuse receives a high degree of media coverage. Unfavorable publicity regarding, for example, the use or misuse of oxycodone or
  other opioid drugs, the limitations of abuse-resistant formulations, public inquiries and investigations into prescription drug
  abuse, litigation or regulatory activity, or the independent actions regarding the sales, marketing, distribution or storage of
  our drug products, could adversely affect our reputation. Such negative publicity could have an adverse effect on the potential
  size of the market for our drug candidates and decrease revenues and royalties, which would adversely affect our business and
  financial results.
  Risks
  Related to Ownership of Our Common Stock
  There
  is a limited market for our common stock which may make it more difficult to dispose of your stock.
  Our
  common stock is currently quoted on the OTCQB under the symbol "RLMD". There is a limited trading market for our
  common stock. Accordingly, there can be no assurance as to the liquidity of any markets that may develop for our common stock,
  the ability of holders of our common stock to sell shares of our common stock, or the prices at which holders may be able to sell
  their common stock.
  A
  sale of a substantial number of shares of our common stock may cause the price of the common stock to decline.
  If our stockholders
  sell substantial amounts of our common stock in the public market, the market price of our common stock could fall. These sales
  also may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem
  reasonable or appropriate. Stockholders who have been issued shares in the Reverse Merger will be able to sell their shares pursuant
  to Rule 144 under the Securities Act of 1933, beginning one year after the stockholders acquired their shares, subject to limitations
  imposed by the lock-up agreements.
  We
  are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other
  projects, thus impairing our ability grow.
  We are a
  public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other
  federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002 (the "Sarbanes-Oxley Act"). The
  costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing
  audited reports to stockholders would cause our expenses to be higher than they would be if we remained privately held and did
  not consummate the Reverse Merger. In addition, we will incur substantial expenses in connection with the preparation of the registration
  statement and related documents required under the terms of our May and June 2014 offerings.
  It may be
  time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by
  the Sarbanes-Oxley Act. We may need to hire additional financial reporting, internal controls and other finance personnel in order
  to develop and implement appropriate internal controls and reporting procedures. If we are unable to comply with the internal
  controls requirements of the Sarbanes-Oxley Act, then we may not be able to obtain the independent accountant certifications required
  by such act, which may preclude us from keeping our filings with the SEC current.
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  If
  we fail to establish and maintain an effective system of internal control, we may not be able to report our financial results
  accurately or to prevent fraud. Any inability to report and file our financial results accurately and timely could harm our reputation
  and adversely impact the trading price of our Common Stock.
  Effective
  internal control is necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial
  reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment
  existed, and our business and reputation with investors may be harmed. As a result, our small size and any current internal control
  deficiencies may adversely affect our financial condition, results of operation and access to capital. We have not performed an
  in-depth analysis to determine if historical un-discovered failures of internal controls exist, and may in the future discover
  areas of our internal control that need improvement.
  The
  issuing of our press release, dated July 1, 2014, which was not in compliance with Rule 134 of the Securities Act of 1933, as
  amended (the "Securities Act") and potentially Section 5(b) of the Securities Act, could subject us to rescission
  rights by investors that are participating in the offering
  On July
  1, 2014, we filed a press release announcing the filing of registration statement on Form S-1, of which this prospectus is a part.
  The press release was not in compliance with the provisions of Rule 134 of the Securities Act. The SEC has regulations concerning
  the ability of an issuer to make public announcements during a registered public offering of its securities. Rule 134 of the Securities
  Act is a safe harbor which permits an issuer to make a public announcement during the waiting period (the period after filing
  the registration statement). As a result, investors in this offering may potentially be entitled to bring suit against the Company
  for not being in compliance with the Securities Act, and such investor may be able to obtain rescission rights. The potential
  costs, risks and liabilities associated with such potential lawsuits, rights of rescission and/or regulatory actions cannot be
  accurately assessed at this time, but in the event such lawsuits, rescission offerings and/or regulatory actions are instituted,
  our Company believes that such actions will not have a material financial effect on our Company.  Also, our Company's
  inability to resolve any potential violation of Section 5 of the Securities Act to the satisfaction of the SEC could result in
  a delay or prohibition in obtaining the effectiveness of any future registration statements, which could hinder or impair the
  ability to obtain future financing.
  Public
  company compliance may make it more difficult to attract and retain officers and directors.
  The Sarbanes-Oxley
  Act and new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.
  As a public company, we expect these new rules and regulations to increase our compliance costs in 2012 and beyond and to make
  certain activities more time consuming and costly. As a public company, we also expect that these new rules and regulations may
  make it more difficult and expensive for us to obtain director and officer liability insurance in the future and we may be required
  to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a
  result, it may be more difficult for us to attract and retain qualified persons to serve on our board of directors or as executive
  officers.
  Our
  stock price may be volatile.
  The market
  price of our Common Stock is likely to be highly volatile and could fluctuate widely in price in response to various factors,
  many of which are beyond our control, including the following:
  ●
  changes in our
      industry;
  ●
  competitive pricing
      pressures;
  ●
  our ability to
      obtain working capital financing;
  ●
  additions or departures
      of key personnel;
  ●
  limited "public
      float" in the hands of a small number of persons whose sales or lack of sales could result in positive or negative pricing
      pressure on the market price for our common stock;
  ●
  sales of our common
      stock;
  ●
  our ability to
      execute our business plan;
  ●
  operating results
      that fall below expectations;
  ●
  loss of any strategic
      relationship;
  ●
  regulatory developments;
  ●
  economic and other
      external factors;
  ●
  period-to-period
      fluctuations in our financial results; and
  ●
  inability to develop
      or acquire new or needed technology or products.
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  In addition,
  the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the
  operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price
  of our Common Stock.
  Our
  Common Stock may be deemed a "penny stock," which would make it more difficult for our investors to sell their shares.
  Our common
  stock may be subject to the "penny stock" rules adopted under Section 15(g) of the Exchange Act. The penny stock
  rules generally apply to companies whose common stock is not listed on The Nasdaq Stock Market or other national securities exchange
  and trades at less than $5.00 per share, other than companies that have had average revenue of at least $6,000,000 for the last
  three years or that have tangible net worth of at least $5,000,000 ($2,000,000 if the company has been operating for three or
  more years). These rules require, among other things, that brokers who trade penny stock to persons other than "established
  customers" complete certain documentation, make suitability inquiries of investors and provide investors with certain information
  concerning trading in the security, including a risk disclosure document and quote information under certain circumstances. Many
  brokers have decided not to trade penny stocks because of the requirements of the penny stock rules and, as a result, the number
  of broker-dealers willing to act as market makers in such securities is limited. If we remain subject to the penny stock rules
  for any significant period, it could have an adverse effect on the market, if any, for our securities. If our securities are subject
  to the penny stock rules, investors will find it more difficult to dispose of our securities.
  You
  may have difficulty trading and obtaining quotations for our Common Stock.
  Our securities
  are actively traded, and the bid and asked prices for our Common Stock on the Over-the-Counter Bulletin Board may fluctuate
  widely. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our securities. This
  severely limits the liquidity of the Common Stock, and would likely reduce the market price of our Common Stock and hamper our
  ability to raise additional capital. There is a limited market for our securities. Accordingly, investors may therefore bear
  the economic risk of an investment in the Securities thereof, for an indefinite period of time. Even if an active market develops
  for the common stock, Rule 144 promulgated under the Securities Act ("Rule 144"), which provides for an exemption from
  the registration requirements under the Securities Act under certain conditions, requires, among other conditions, a one-year
  holding period prior to the resale (in limited amounts) of securities acquired in a non-public offering without having to satisfy
  the registration requirements under the Securities Act. There can be no assurance that we will fulfill any reporting requirements
  in the future under the Securities Exchange Act of 1934, as amended, or disseminate to the public any current financial or other
  information concerning the Company, as is required by Rule 144 as part of the conditions of its availability. Our securities have
  not been registered under the Securities Act.
  USE
  OF PROCEEDS
  The
  shares which may be sold pursuant to this prospectus will be sold for the respective accounts of each of the selling stockholders.
  Accordingly, the Company will not realize any proceeds from the sale of the shares, except that it will derive proceeds if options
  currently outstanding or hereafter granted are exercised. If exercised, such funds will be available to the Company for working
  capital and general corporate purposes. No assurance can be given, however, as to when or if any or all of the options will be
  exercised. All expenses of the registration of the shares have been paid for by the Company. See "Selling Stockholders"
  and "Plan of Distribution."
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  Table of Contents
  SELLING
  STOCKHOLDERS
  The
  847,147 shares of our common stock to which this reoffer prospectus relates is comprised entirely of shares issuable upon the
  exercise of options granted under the Plan to the selling stockholders named below, and are being registered for reoffers and
  resales by such selling stockholders, who acquired the shares pursuant to one of our "employee benefit plans" as that
  term is defined in Rule 405 of Regulation C under the Securities Act. The shares of common stock that may be resold pursuant to
  this prospectus may be subject the satisfaction of certain applicable vesting conditions pursuant to the terms of the respective
  grants. Such selling stockholders may resell all, a portion, or none of the shares of common stock from time to time while this
  prospectus is effective. Any changed information will be set forth in an amendment to the registration statement or supplement
  to this reoffer prospectus, to the extent required by law.
  The
  following table sets forth the name and relationship to the Company of the selling stockholders and information regarding beneficial
  ownership of our common stock by the selling stockholders as of October 1, 2015. Unless otherwise indicated, beneficial ownership
  is determined in accordance with the rules of the Commission, and is based upon information provided by each respective selling
  stockholder identified below and other public documents filed with the Commission.
  Unless
  otherwise specified, the address of each of the selling stockholders listed below is c/o Relmada Therapeutics, Inc., 757
  Third Avenue, Suite 2018, New York, NY 10017.
  Selling Stockholder
  Position
  Total Shares
  Beneficially
  Owned Prior
  to Offering (1)
  Maximum
  Shares
  Offered
  Pursuant
  to this
  Prospectus
  Shares
  Beneficially
  Owned
  Following
  Resale (2)
  Percentage
  of
  Outstanding
  Shares of
  Common Stock
  after the
  Offering (3)
  Charles Casamento
  Director
  25,765
  25,765
  (4)
  Christopher James
  Employee
  30,000
  30,000
  (5)
  -
  *
  Christine Silverstein
  Employee
  50,400
  50,400
  (6)
  -
  *
  Danny Kao
  Employee
  46,380
  42,500
  (7)
  3,880
  *
  Donna Cummings
  Employee
  1,700
  1,700
  (8)
  -
  *
  Douglas Beck
  Chief Financial Officer
  71,840
  71,840
  (9)
  -
  *
  Elizabeth Nolan
  Employee
  80,000
  80,000
  (10)
  Fai Jim
  Employee
  24,000
  24,000
  (11)
  -
  *
  Kulendiran Purushothaman
  Employee
  40,000
  40,000
  (12)
  -
  *
  Michael Becker
  Employee
  82,000
  82,000
  (13)
  -
  *
  Nabil Yazgi
  Director
  49,733
  9,733
  (14)
  40,000
  *
  Richard Mangano
  Employee
  56,000
  56,000
  (15)
  -
  *
  Sandesh Seth
  Director
  9,733
  9,733
  (16)
  -
  *
  Sergio Traversa
  Chief Executive Officer
  413,284
  313,743
  (17)
  99,541
  *
  Sheeram Agharkar
  Director
  9,733
  9,733
  (18)
  -
  *
  (1)
  The
      securities "beneficially owned" by a person are determined in accordance with the definition of
      "beneficial     ownership" set forth in the rules and regulations promulgated under the Exchange Act, and
      accordingly, may include securities     owned by and for, among others, the spouse and/or minor children of an individual and
      any other relative who has the same     home as such individual, as well as other securities as to which the individual has
      or shares voting or investment power or     which such person has the right to acquire within 60 days of October 1, 2015
      pursuant to the exercise of options, or otherwise.      Beneficial ownership may be disclaimed as to certain of the
      securities.
  (2)
  Assumes
      that all shares of common stock offered by this prospectus are sold in this offering and that no other transactions with respect
      to shares of our common stock occur.
  (3)
  Based on 11,014,155 shares of common stock and
      71,672 shares of Class A preferred stock issued and outstanding as of October 1, 2015.
  (4)
  Includes
      25,765 shares of common stock underlying outstanding options granted to the selling stockholder .
  (5)
  Includes
      (i) 16,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 14,000 shares
      of restricted common stock granted to the selling stockholder.
  34
  Table of Contents
  (6)
  Includes
      (i) 40,400 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 10,000 shares
      of restricted common stock granted to the selling stockholder.
  (7)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (8)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (9)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (10)
  Includes
      (i) 50,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 30,000 shares
      of restricted common stock granted to the selling stockholder.
  (11)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (12)
  Includes
      (i) 20,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 20,000 shares
      of restricted common stock granted to the selling stockholder.
  (13)
  Includes
      (i) 62,000 shares of common stock underlying outstanding options granted to the selling stockholder and (ii) 20,000 shares
      of restricted common stock granted to the selling stockholder.
  (14)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (15)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (16)
  Includes all shares of common stock underlying outstanding options granted to the selling stockholder
  (17)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  (18)
  Includes
      all shares of common stock underlying outstanding options granted to the selling stockholder.
  *
  Less
      than 1% of our common stock.
  35
  Table of Contents
  PLAN
  OF DISTRIBUTION
  The
  common shares being offered for resale by the selling stockholders consist of 847,147 shares of common stock underlying
  outstanding options and restricted common stock granted to the selling stockholders under the Plans. We will pay any fees and
  expenses incurred by us incident to the registration of the securities.
  Each
  selling stockholder of the securities and any of their pledgees, assignees and successors-in-interest permitted under the Plan
  may, from time to time, sell any or all of their securities covered hereby on OTCQB or any other stock exchange, market or trading
  facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A selling
  stockholder may use any one or more of the following methods when selling securities:
  ●
  ordinary
      brokerage transactions and transactions in which the broker-dealer solicits purchasers;
  ●
  block
      trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the
      block as principal to facilitate the transaction;
  ●
  purchases
      by a broker-dealer as principal and resale by the broker-dealer for its account;
  ●
  an
      exchange distribution in accordance with the rules of the applicable exchange;
  ●
  privately
      negotiated transactions;
  ●
  settlement
      of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
  ●
  in
      transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such securities
      at a stipulated price per security;
  ●
  through
      the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
  ●
  a
      combination of any such methods of sale; or
  ●
  any
      other method permitted pursuant to applicable law.
  The
  selling stockholders may also sell securities under Rule 144 under the Securities Act, if available, rather than under this prospectus.
  The
  amount of our common stock to be reoffered or resold by means of this prospectus by each selling stockholder, and any other person
  with whom such selling stockholder is acting in concert for the purpose of selling securities of our company, may not exceed,
  during any three month period, the amount specified in Rule 144(e) of the Securities Act.
  Broker-dealers
  engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive
  commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities,
  from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an
  agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a
  principal transaction a markup or markdown in compliance with FINRA IM-2440.
  In
  connection with the sale of the securities or interests therein, the selling stockholders may enter into hedging transactions
  with broker-dealers or other financial institutions, which may in turn engage in short sales of the securities in the course of
  hedging the positions they assume. The selling stockholders may also sell securities short and deliver these securities to close
  out their short positions, or loan or pledge the securities to broker-dealers that in turn may sell these securities. The selling
  stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one
  or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered
  by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus
  (as supplemented or amended to reflect such transaction).
  The
  selling stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be "underwriters"
  within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
  or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
  under the Securities Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding,
  directly or indirectly, with any person to distribute the securities.
  The
  resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities
  laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or
  qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and
  is complied with.
  Under
  applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not
  simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined
  in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable
  provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of
  purchases and sales of securities of the common stock by the selling stockholders or any other person. We will make copies of
  this prospectus available to the selling stockholders and have informed them of the need to deliver a copy of this prospectus
  to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
  36
  Table of Contents
  LEGAL
  MATTERS
  The
  validity of the shares of common stock being offered pursuant to this prospectus will be passed upon by Fennemore Craig, P.C.,
  Reno, NV.
  EXPERTS
  The
  audited financial statements incorporated by reference in this prospectus and elsewhere in the registration statement have been
  so incorporated by reference in reliance upon the report of GBH CPAs, PC an independent registered public accounting firm, upon
  the authority of said firm as experts in accounting and auditing in giving said report.
  WHERE
  YOU CAN FIND MORE INFORMATION
  We
  filed with the Commission a registration statement under the Securities Act for the common stock in this offering. This prospectus
  does not contain all of the information in the registration statement and the exhibits and schedule that were filed with the registration
  statement. For further information with respect to us and our common stock, we refer you to the registration statement and the
  exhibits that were filed with the registration statement. Statements contained in this prospectus about the contents of any contract
  or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and we refer you
  to the full text of the contract or other document filed as an exhibit to the registration statement.
  We
  file annual, quarterly, and current reports and other information with the Commission. Our filings with the the Commission are
  available to the public on the commission's website at www.sec.gov. Those filings are also available to the public on our
  corporate website at www.relmada.com. The information we file with the Commission or contained on, or linked to through, our corporate
  website or any other website that we may maintain is not part of this prospectus or the registration statement of which this prospectus
  is a part. You may also read and copy, at the Commission's prescribed rates, any document we file with the Commission, including
  the registration statement (and its exhibits) of which this prospectus is a part, at the Commission's Public Reference Room
  located at 100 F Street, N.E., Washington, D.C. 20549. You can call the Commission at 1-800-SEC-0330 to obtain information on
  the operation of the Public Reference Room.
  INCORPORATION
  OF CERTAIN DOCUMENTS BY REFERENCE
  We
  are incorporating by reference certain information that we have filed with the Commission under the informational requirements
  of the Exchange Act, which means that we are disclosing it to you by referring to another document filed separately with the Commission.
  The information contained in the documents we are incorporating by reference is considered to be a part of this prospectus, and
  the information that we later file with the Commission will automatically update and supersede the information contained or incorporated
  by reference in this prospectus. Accordingly, we incorporate by reference:
  ●
  Our Form 10-K for the year ended June 30, 2015,
  filed with the Securities and Exchange Commission on September 11, 2015; and
  ●
  The
      description of our common stock, which is contained in our Form 8-K, filed with the Securities and Exchange Commission on
      May 27, 2014.
  37
  Table of Contents
  All
  documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of this
  prospectus and prior to the filing of a post-effective amendment indicating that all securities offered have been sold or which
  deregisters all securities then remaining unsold, are incorporated by reference in this prospectus and are a part of this prospectus
  from the respective dates of filings of such documents. Any statement contained herein or in a document incorporated or deemed
  to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus to the extent
  that a statement contained herein or in any other filed document which also is or is deemed to be incorporated by reference herein
  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
  may request a copy of any filings or information incorporated herein by reference, at no cost, by writing or telephoning us at
  the following address and telephone number: Relmada Therapeutics, Inc., 757 3rd Avenue, Suite 2018, New York, NY 10017, Attention:
  Sergio Traversa, telephone number (212) 376-5776.
  DISCLOSURE
  OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
  We
  are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes,
  or NRS.
  Section
  78.138 of the NRS provides that, unless the corporation's Articles of Incorporation provide otherwise, a director or officer
  will not be individually liable unless it is proven that (i) the director's or officer's acts or omissions constituted
  a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of
  the law. Our Articles of Incorporation provide that no director or officer shall be personally liable to the corporation or any
  of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability of a director or
  officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii) payment of dividends
  in violation of Section 78-300 of the NRS.
  Section
  78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid
  in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding,
  if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or
  director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding,
  had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes
  indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion
  of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent
  that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for
  such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or
  otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.
  Section
  78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending
  a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination
  by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation
  to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount
  if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified
  by the company if so provided in the corporations articles of incorporation, by-laws, or other agreement. Section 78.751 of the
  NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of
  incorporation, by-laws, or other agreement.
  Section
  78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf
  of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the
  company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise,
  for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee,
  or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him or her against such
  liability and expenses.
  The
  By-laws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS.
  The
  indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter
  acquire under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person's
  official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased
  to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such
  person.
  We
  maintain a general liability insurance policy that covers liabilities of directors and officers of our corporation arising out
  of claims based on acts or omissions in their capacities as directors or officers.
  No
  one has been authorized 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, such information or representations must not be relied upon as having been authorized
  by us. This prospectus does not constitute an offer or a solicitation by anyone in any jurisdiction in which such offer or solicitation
  is not authorized or in which the person making such offer is not qualified to do so or to anyone to whom it is unlawful to make
  such offer or solicitation. Neither the delivery of this prospectus nor any sale hereunder shall, under any circumstances, create
  any implication that there has not been any change in our affairs since the date hereof.
  38
  Table of Contents
  PART
  II
  INFORMATION
  REQUIRED IN THE REGISTRATION STATEMENT
  Item
      3.
  Incorporation of Documents by Reference.
  We
  are subject to the informational requirements of the Securities Exchange Act of 1934, as amended (the "Exchange Act")
  and, in accordance therewith, file reports and other information with the Commission. The following documents, or portions thereof,
  filed by us with the Commission pursuant to the Exchange Act, are incorporated by reference in this Registration Statement:
  ●
  Our Form 10-K as of June 30, 2015 and 2014 and for
      the     year     ended     June     30,     2015, for the six months ended June 30, 2014, and for the year ended December
      31, 2013, filed with     the     Securities     and     Exchange     Commission     on     September     11,     2015;
      and
  ●
  The
      description of our common stock, which is contained in our Form 8-K, filed with the Securities and Exchange Commission on
      May 27, 2014.
  All
  documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of this
  Registration Statement and prior to the filing of a post-effective amendment to this Registration Statement indicating that all
  securities offered have been sold or which deregisters all securities then remaining unsold, are incorporated by reference in
  this Registration Statement and are a part of this Registration Statement from the respective dates of filings of such documents.
  Any statement contained herein or in a document incorporated or deemed to be incorporated by reference herein shall be deemed
  to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein or in
  any other filed document which also is or is deemed to be incorporated by reference herein 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 Registration Statement.
  Item
      4.
  Description of Securities.
  Not
  applicable.
  II-
  1
  Table of Contents
  Item 5.
  Interests of Named Experts and Counsel.
  Not
  applicable.
  Item 6.
  Indemnification of Directors and Officers.
  We
  are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes,
  or NRS.
  Section
  78.138 of the NRS provides that, unless the corporation's Articles of Incorporation provide otherwise, a director or officer
  will not be individually liable unless it is proven that (i) the director's or officer's acts or omissions constituted
  a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of
  the law. Our Articles of Incorporation provide that no director or officer shall be personally liable to the corporation or any
  of its stockholders for damages for any breach of fiduciary duty as a director or officer except for liability of a director or
  officer for (i) acts or omissions involving intentional misconduct, fraud, or a knowing violation of law or (ii) payment of dividends
  in violation of Section 78-300 of the NRS.
  Section
  78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid
  in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding,
  if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or
  director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding,
  had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS also precludes
  indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion
  of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent
  that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for
  such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or
  otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.
  Section
  78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending
  a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination
  by the stockholders, the disinterested board members, or by independent legal counsel. Section 78.751 of NRS requires a corporation
  to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount
  if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified
  by the company if so provided in the corporations articles of incorporation, bylaws, or other agreement. Section 78.751 of the
  NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of
  incorporation, bylaws, or other agreement.
  Section
  78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf
  of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the
  company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise,
  for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee,
  or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability
  and expenses.
  The
  Bylaws implement the indemnification and insurance provisions permitted by Chapter 78 of the NRS.
  The
  indemnification rights set forth above shall not be exclusive of any other right which an indemnified person may have or hereafter
  acquire under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise, both as to action in such person's
  official capacity and as to action in another capacity while holding such office, and shall continue as to a person who has ceased
  to be a director, officer, employee, or agent and shall inure to the benefit of the heirs, executors, and administrators of such
  person.
  We
  maintain a general liability insurance policy that covers liabilities of directors and officers of our corporation arising out
  of claims based on acts or omissions in their capacities as directors or officers.
  Item 7.
  Exemption From Registration Claimed.
  Not
  applicable.
  II-
  2
  Table of Contents
  Item 8.
  Exhibits.
  Exhibit
  No.
  Description
  4.1
  Specimen
      Common Stock Certificate*
  4.2
  Articles
      of Incorporation (incorporated by reference to Exhibit 3.1 to Registration Statement on Form S-1 filed with the SEC on November
      13, 2012).
  4.3
  Certificate
      of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Report on Form 8-K filed with the SEC on May
      19, 2014).
  4.4
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective May 30, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on May 27, 2014).
  4.5
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective July 8, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on July 14, 2014).
  4.6
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective February 12, 2015 (incorporated by reference to Exhibit 3.1
      to Form 10-Q filed with the SEC on February 13, 2015).
  4.7
  Nevada
      Certificate of Change Pursuant to NRS 78,209, effective August 11, 2015 (incorporated by reference to Exhibit 3.1 to Form
      8-K filed with the SEC on August 10, 2015).
  4.8
  Bylaws
      of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 of the Company's Form 8-K filed with the SEC
      on May 27, 2014).
  5.1
  Opinion
      of Fennemore Craig, P.C. *
  10.1
  Relmada
      Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.14 to Form S-1/A filed
      with the SEC on December 9, 2015).
  10.2
  First
      Amendment to Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit
      10.1 to Form 8-K filed with the SEC on August 7, 2015).
  23.1
  Consent
      of GBH CPAs, PC *
  23.2
  Consent
      of Fennemore Craig, P.C.  (included in Exhibit 5.1) *
  24.1
  Power
      of Attorney (included on signature page) *
  *
  Filed herewith
  II-
  3
  Table of Contents
  Item 9.
  Undertakings.
  The
  undersigned Company hereby undertakes:
  (1)
           To file, during any period in which offers or sales are being made, a post-effective
  amendment to this Registration Statement:
  (i)
          To include any prospectus required by Section 10(a)(3) of the Securities Act;
  (ii)
          To reflect in the prospectus any facts or events arising after the effective date
  of the Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent
  a fundamental change in the information set forth in the Registration Statement. Notwithstanding the foregoing, any increase or
  decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered)
  and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus
  filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than
  a 20 percent change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table
  in the effective Registration Statement;
  (iii)
          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;
  Provided
  ,
  however
  , that paragraphs (1)(i) and (1)(ii) above do not apply if the information required to be included in a post-effective
  amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Company pursuant to Section
  13 or Section 15(d) of the Securities Exchange Act that are incorporated by reference in the Registration Statement.
  (2)         That, for the purpose of determining any liability under the Securities
  Act, 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.
  The
  undersigned Company hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of
  the Company's annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable,
  each filing of an employee benefit plan's annual report pursuant to Section 15(d) of the Exchange Act) 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.
  The
  undersigned Company hereby undertakes to deliver or cause to be delivered with the prospectus, to each person to whom the prospectus
  is sent or given, the latest annual report, to security holders that is incorporated by reference in the prospectus and furnished
  pursuant to and meeting the requirements of Rule 14a–3 or Rule 14c–3 under the Exchange Act; and, where interim financial
  information required to be presented by Article 3 of Regulation S-X is not set forth in the prospectus, to deliver, or cause to
  be delivered to each person to whom the prospectus is sent or given, the latest quarterly report that is specifically incorporated
  by reference in the prospectus to provide such interim financial information.
  Insofar
  as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons
  of the Company pursuant to the foregoing provisions, or otherwise, the Company has been advised that in the opinion of the 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 Company of expenses incurred or paid
  by a director, officer or controlling person of the Company 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 Company 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.
  II-
  4
  Table of Contents
  SIGNATURES
  Pursuant
  to the requirements of the Securities Act of 1933, the Company 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, in the City of New York, State of New York, on this 2nd day of October, 2015.
  Relmada
      Therapeutics, Inc.
  By:
  /s/
      Sergio Traversa
  Name:
  Sergio
      Traversa
  Title:
  Chief Executive
      Officer
  (Duly Authorized
      Officer and Principal Executive Officer)
  By:
  /s/
      Douglas Beck
  Name:
  Douglas Beck
  Title:
  Chief Financial Officer
  (Duly Authorized Officer and Principal
      Financial and Accounting Officer)
  POWER
  OF ATTORNEY
  Each
  person whose signature appears below hereby appoints each of Sandesh Seth and Sergio Traversa, severally, acting alone and without
  the other, his or her true and lawful attorney-in-fact, with full power of substitution, and with the authority to execute in
  the name of each such person, any and all amendments (including without limitation, post-effective amendments) to this registration
  statement, to sign any and all additional registration statements relating to the same offering of securities as this registration
  statement that are filed pursuant to Rule 462(b) of the Securities Act of 1933, and to file such registration statements with
  the Securities and Exchange Commission, together with any exhibits thereto and other documents therewith, necessary or advisable
  to enable the registrant to comply with the Securities Act of 1933, and any rules, regulations and requirements of the Securities
  and Exchange Commission in respect thereof, which amendments may make such other changes in the registration statement as the
  aforesaid attorney-in-fact executing the same deems appropriate.
  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.
  Signature
  Title
  Date
  /s/
      Sergio Traversa
  Chief
      Executive Officer and Director
  October 2, 2015
  Sergio
      Traversa
  (principal
      executive officer)
  /s/
      Douglas Beck
  Chief
      Financial Officer
  October 2, 2015
  Douglas
      Beck
  (Principal
      Financial and Accounting Officer)
  /s/
      Sandesh Seth
  Chairman
      of the Board
  October 2, 2015
  Sandesh
      Seth
  /s/
      Shreeram Agharkar
  Director
  October 2, 2015
  Shreeran
      Agharkar
  /s/
      Nabil Yazgi
  Director
  October 2, 2015
  Nabil
      Yazgi
  /s/
      Charles Casamento
  Director
  October 2, 2015
  Charles
      Casamento
  II-
  5
  Table of Contents
  INDEX
  TO EXHIBITS
  Exhibit
      No.
  Description
  4.1
  Specimen
      Common Stock Certificate*
  4.2
  Articles
      of Incorporation (incorporated by reference to Exhibit 3.1 to Registration Statement on Form S-1 filed with the SEC on November
      13, 2012).
  4.3
  Certificate
      of Designation dated May 13, 2014 (incorporated by reference to Exhibit 4.1 to Report on Form 8-K filed with the SEC on May
      19, 2014).
  4.4
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective May 30, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on May 27, 2014).
  4.5
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective July 8, 2014 (incorporated by reference to Exhibit 3.1 to
      Form 8-K filed with the SEC on July 14, 2014).
  4.6
  Nevada
      Certificate of Amendment to Articles of Incorporation, effective February 12, 2015 (incorporated by reference to Exhibit 3.1
      to Form 10-Q filed with the SEC on February 13, 2015).
  4.7
  Nevada
      Certificate of Change Pursuant to NRS 78,209, effective August 11, 2015 (incorporated by reference to Exhibit 3.1 to Form
      8-K filed with the SEC on August 10, 2015).
  4.8
  Bylaws
      of Relmada Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 of the Company's Form 8-K filed with the SEC
      on May 27, 2014).
  5.1
  Opinion
      of Fennemore Craig, P.C. *
  10.1
  Relmada
      Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit 10.14 to Form S-1/A filed
      with the SEC on December 9, 2015).
  10.2
  First
      Amendment to Relmada Therapeutics, Inc. 2014 Stock Option and Equity Incentive Plan (incorporated by reference to Exhibit
      10.1 to Form 8-K filed with the SEC on August 7, 2015).
  23.1
  Consent
      of GBH CPAs, PC *
  23.2
  Consent
      of Fennemore Craig, P.C.  (included in Exhibit 5.1) *
  24.1
  Power
      of Attorney (included on signature page) *
  *
  Filed herewith
  E-1